Devices

Device Recall Solarice Rapid Exchange Balloon Dilatation Catheter

  • Modèle / numéro de série
    Product Number / CFN GTIN Lot SLC2525X 00643169680234 212610381 SLC3520X 00643169680449 212610395 SLC1520X 00643169680043 212610391 SLC2015X 00643169680081 212610384 SLC2020X 00643169680098 212621132 SLC2515X 00643169680210 212610388 SLC2520X 00643169680227 212621130 SLC4015X 00643169680531 212610378 SLC27520X 00643169680289 212621127 SLC27515X 00643169680272 212621128 SLC3515X 00643169680432 212621129 SLC3020X 00643169680340 212663250 SLC22510X 00643169680135 212671839 SLC3010X 00643169680319 212663249 SLC22506X 00643169680128 212671834 SLC2506X 00643169680180 212671836 SLC2025X 00643169680104 212671880 SLC37515X 00643169680487 212671833 SLC32515X 00643169680388 212671838 SLC4010X 00643169680517 212671837 SLC22520X 00643169680166 212663251 SLC3006X 00643169680302 212671835 SLC2020X 00643169680098 212691165 SLC2512X 00643169680203 212691118 SLC2515X 00643169680210 212691164 SLC2015X 00643169680081 212691160 SLC22512X 00643169680142 212691163 SLC2025X 00643169680104 212691167 SLC2020X 00643169680098 212702017 SLC2530X 00643169680241 212691173 SLC1512X 00643169680029 212691119 SLC2515X 00643169680210 212702018 SLC2015X 00643169680081 212702463 SLC2012X 00643169680074 212710905 SLC2030X 00643169680111 212710910 SLC2510X 00643169680197 212710908 SLC2512X 00643169680203 212702020 SLC2520X 00643169680227 212702019 SLC22520X 00643169680166 212702021 SLC2015X 00643169680081 212702016 SLC3030X 00643169680364 212691171 SLC2020X 00643169680098 212702465 SLC2012X 00643169680074 212709027 SLC2015X 00643169680081 212709026 SLC1520X 00643169680043 212702462 SLC2525X 00643169680234 212691168 SLC22525X 00643169680173 212691166 SLC2012X 00643169680074 212709723 SLC1512X 00643169680029 212702464 SLC2515X 00643169680210 212709726 SLC2512X 00643169680203 212709724 SLC3020X 00643169680340 212710906 SLC1510X 00643169680012 212710907 SLC1515X 00643169680036 212709725 SLC1520X 00643169680043 212709025 SLC4015X 00643169680531 212691162 SLC3512X 00643169680425 212710909 SLC4020X 00643169680548 212691170 SLC27525X 00643169680296 212691172 SLC1512X 00643169680029 212724814 SLC1506X 00643169680005 212724811 SLC1515X 00643169680036 212724813 SLC22515X 00643169680159 212724812 SLC3515X 00643169680432 212691169 SLC1512X 00643169680029 212752474 SLC2020X 00643169680098 212760551 SLC2015X 00643169680081 212760550 SLC2520X 00643169680227 212760552 SLC32512X 00643169680371 212751958 SLC2520X 00643169680227 212751959 SLC2006X 00643169680050 212752340 SLC3520X 00643169680449 212691161 SLC37520X 00643169680494 212751957 SLC2010X 00643169680067 212773513 SLC2015X 00643169680081 212796639 SLC3015X 00643169680333 212796634 SLC2515X 00643169680210 212773514 SLC2515X 00643169680210 212796637 SLC3020X 00643169680340 212796740 SLC2512X 00643169680203 212796633 SLC3510X 00643169680418 212796632 SLC3030X 00643169680364 212796635 SLC2530X 00643169680241 212796638 SLC1520X 00643169680043 212796636 SLC2020X 00643169680098 212796741 SLC2015X 00643169680081 212820860 SLC2515X 00643169680210 212820856 SLC2020X 00643169680098 212820861 SLC2520X 00643169680227 212820857 SLC2012X 00643169680074 212820850 SLC3020X 00643169680340 212820859 SLC3012X 00643169680326 212820853 SLC3010X 00643169680319 212820854 SLC3520X 00643169680449 212820851 SLC37512X 00643169680470 212820847 SLC27515X 00643169680272 212820849 SLC1515X 00643169680036 212820858 SLC2512X 00643169680203 212820852 SLC2020X 00643169680098 212835827 SLC22510X 00643169680135 212835833 SLC2520X 00643169680227 212835823 SLC1515X 00643169680036 212835829 SLC1510X 00643169680012 212835824 SLC2512X 00643169680203 212835832 SLC2012X 00643169680074 212835830 SLC2525X 00643169680234 212835825 SLC3520X 00643169680449 212835828 SLC3010X 00643169680319 212835831 SLC3530X 00643169680463 212835826 SLC4015X 00643169680531 212835822 SLC2515X 00643169680210 212846677 SLC2015X 00643169680081 212855147 SLC27515X 00643169680272 212846678 SLC2010X 00643169680067 212855152 SLC2012X 00643169680074 212846679 SLC3025X 00643169680357 212855146 SLC3015X 00643169680333 212855153 SLC22512X 00643169680142 212846676 SLC2512X 00643169680203 212846741 SLC2020X 00643169680098 212846740 SLC2510X 00643169680197 212855154 SLC1520X 00643169680043 212855151 SLC22515X 00643169680159 212855150 SLC3030X 00643169680364 212855155 SLC2012X 00643169680074 212855148 SLC2015X 00643169680081 212884040 SLC1510X 00643169680012 212884042 SLC2020X 00643169680098 212883779 SLC2515X 00643169680210 212883778 SLC2512X 00643169680203 212883776 SLC2012X 00643169680074 212904436 SLC2520X 00643169680227 212884041 SLC2015X 00643169680081 212904428 SLC2510X 00643169680197 212904437 SLC2020X 00643169680098 212904427 SLC2512X 00643169680203 212904431 SLC2515X 00643169680210 212904430 SLC2520X 00643169680227 212904435 SLC3515X 00643169680432 212904424 SLC3020X 00643169680340 212904433 SLC1512X 00643169680029 212904432 SLC1520X 00643169680043 212883777 SLC27512X 00643169680265 212904425 SLC4020X 00643169680548 212904426 SLC2020X 00643169680098 212917146 SLC2015X 00643169680081 212917148 SLC2010X 00643169680067 212917149 SLC2515X 00643169680210 212917150 SLC2520X 00643169680227 212917154 SLC2006X 00643169680050 212917145 SLC2030X 00643169680111 212917152 SLC3010X 00643169680319 212917147 SLC2025X 00643169680104 212917151 SLC2506X 00643169680180 212917144 SLC1520X 00643169680043 212904429 SLC2015X 00643169680081 212931282 SLC2012X 00643169680074 212931285 SLC1515X 00643169680036 212917153 SLC1515X 00643169680036 212904434 SLC2020X 00643169680098 212931281 SLC2512X 00643169680203 212931287 SLC2520X 00643169680227 212931292 SLC2510X 00643169680197 212931291 SLC2010X 00643169680067 212931293 SLC2015X 00643169680081 212938539 SLC2020X 00643169680098 212938538 SLC3012X 00643169680326 212931288 SLC3510X 00643169680418 212931280 SLC2515X 00643169680210 212931284 SLC2515X 00643169680210 212938680 SLC1520X 00643169680043 212931283 SLC3020X 00643169680340 212931286 SLC1515X 00643169680036 212931290 SLC22520X 00643169680166 212931099 SLC2530X 00643169680241 212938532 SLC22525X 00643169680173 212931289 SLC2525X 00643169680234 212938534 SLC22512X 00643169680142 212938535 SLC3006X 00643169680302 212938530 SLC3025X 00643169680357 212938537 SLC2020X 00643169680098 212948305 SLC2015X 00643169680081 212948306 SLC2012X 00643169680074 212948310 SLC2010X 00643169680067 212955580 SLC2520X 00643169680227 212948308 SLC2515X 00643169680210 212948312 SLC2030X 00643169680111 212948314 SLC2512X 00643169680203 212948315 SLC27512X 00643169680265 212948303 SLC22520X 00643169680166 212948307 SLC3015X 00643169680333 212948313 SLC22512X 00643169680142 212955581 SLC22510X 00643169680135 212955156 SLC22515X 00643169680159 212955157 SLC2520X 00643169680227 212955584 SLC2015X 00643169680081 212967871 SLC2015X 00643169680081 212955582 SLC2020X 00643169680098 212967867 SLC3020X 00643169680340 212948311 SLC27515X 00643169680272 212955158 SLC1515X 00643169680036 212948309 SLC1520X 00643169680043 212948304 SLC3030X 00643169680364 212955159 SLC3020X 00643169680340 212955583 SLC2010X 00643169680067 212967874 SLC3012X 00643169680326 212967885 SLC27520X 00643169680289 212967864 SLC2515X 00643169680210 212967879 SLC2520X 00643169680227 212967877 SLC1515X 00643169680036 212967882 SLC2010X 00643169680067 212982918 SLC1520X 00643169680043 212982913 SLC2520X 00643169680227 212982911 SLC2015X 00643169680081 212982915 SLC2012X 00643169680074 212982912 SLC2515X 00643169680210 212982914 SLC1515X 00643169680036 212990853 SLC1510X 00643169680012 212990841 SLC2530X 00643169680241 212982909 SLC2525X 00643169680234 212982916 SLC4010X 00643169680517 212938531 SLC4012X 00643169680524 212938533 SLC4025X 00643169680555 212938529 SLC1512X 00643169680029 212990842 SLC3020X 00643169680340 212982960 SLC1520X 00643169680043 212990854 SLC2010X 00643169680067 212990847 SLC2015X 00643169680081 212990852 SLC4015X 00643169680531 212938536 SLC27525X 00643169680296 213012284 SLC2006X 00643169680050 212990846 SLC2512X 00643169680203 212982917 SLC3512X 00643169680425 212990797 SLC3515X 00643169680432 212990844 SLC3520X 00643169680449 212990798 SLC3030X 00643169680364 212990848 SLC2515X 00643169680210 212990855 SLC3010X 00643169680319 212990799 SLC3015X 00643169680333 212990845 SLC2020X 00643169680098 212982919 SLC2025X 00643169680104 212990843 SLC2520X 00643169680227 212990850 SLC2020X 00643169680098 212990851 SLC22515X 00643169680159 212990849 SLC2012X 00643169680074 212990856 SLC4020X 00643169680548 212990840 SLC3510X 00643169680418 213037271 SLC22515X 00643169680159 213037273 SLC4015X 00643169680531 213037275 SLC4030X 00643169680562 213037272 SLC1506X 00643169680005 213037274 SLC2012X 00643169680074 213069710 SLC2512X 00643169680203 213069706 SLC2515X 00643169680210 213069709 SLC2010X 00643169680067 213069707 SLC2020X 00643169680098 213069713 SLC2520X 00643169680227 213069703 SLC1515X 00643169680036 213069716 SLC1512X 00643169680029 213069708 SLC1520X 00643169680043 213069714 SLC1515X 00643169680036 213079398 SLC2030X 00643169680111 213069712 SLC3015X 00643169680333 213069702 SLC3020X 00643169680340 213069700 SLC2010X 00643169680067 213079393 SLC2015X 00643169680081 213079390 SLC4015X 00643169680531 213079394 SLC4020X 00643169680548 213069711 SLC2530X 00643169680241 213069705 SLC2020X 00643169680098 213079391 SLC2015X 00643169680081 213069715 SLC2512X 00643169680203 213079388 SLC2012X 00643169680074 213079400 SLC3015X 00643169680333 213079399 SLC1512X 00643169680029 213079392 SLC2520X 00643169680227 213079395 SLC1520X 00643169680043 213079396 SLC3012X 00643169680326 213069717 SLC3010X 00643169680319 213069704 SLC22510X 00643169680135 213079389 SLC2530X 00643169680241 213079397 SLC3520X 00643169680449 213069701 SLC3512X 00643169680425 213079387 SLC27515X 00643169680272 213079401 SLC2520X 00643169680227 213093659 SLC3020X 00643169680340 213093654 SLC1510X 00643169680012 213093653 SLC27520X 00643169680289 213093656 SLC3515X 00643169680432 213093652 SLC3030X 00643169680364 213093655 SLC1520X 00643169680043 213093658 SLC2012X 00643169680074 213093657 SLC2010X 00643169680067 213102929 SLC2015X 00643169680081 213102251 SLC2020X 00643169680098 213102252 SLC2512X 00643169680203 213102928 SLC3015X 00643169680333 213102927 SLC2530X 00643169680241 213102250 SLC22506X 00643169680128 213102926 SLC2510X 00643169680197 213145990 SLC1512X 00643169680029 213118225 SLC1515X 00643169680036 213145995 SLC2515X 00643169680210 213145994 SLC2015X 00643169680081 213151478 SLC3520X 00643169680449 213102930 SLC3010X 00643169680319 213118226 SLC27512X 00643169680265 213118223 SLC22515X 00643169680159 213145992 SLC3515X 00643169680432 213145991 SLC3512X 00643169680425 213145993 SLC2015X 00643169680081 213158197 SLC2020X 00643169680098 213158196 SLC1520X 00643169680043 213158194 SLC1512X 00643169680029 213158191 SLC2515X 00643169680210 213158192 SLC1512X 00643169680029 213165100 SLC2010X 00643169680067 213158195 SLC3015X 00643169680333 213158189 SLC22512X 00643169680142 213158193 SLC27520X 00643169680289 213158200 SLC2012X 00643169680074 213151479 SLC3020X 00643169680340 213151477 SLC2520X 00643169680227 213151482 SLC2020X 00643169680098 213151475 SLC1506X 00643169680005 213151476 SLC2030X 00643169680111 213151481 SLC2530X 00643169680241 213151483 SLC2525X 00643169680234 213151480 SLC3506X 00643169680401 213118222 SLC2010X 00643169680067 213164957 SLC3012X 00643169680326 213158188 SLC3010X 00643169680319 213158190 SLC2020X 00643169680098 213164954 SLC27515X 00643169680272 213164953 SLC2015X 00643169680081 213164955 SLC2520X 00643169680227 213164959 SLC22520X 00643169680166 213164956 SLC2015X 00643169680081 213171625 SLC2515X 00643169680210 213165101 SLC3510X 00643169680418 213164958 SLC3030X 00643169680364 213158199 SLC2010X 00643169680067 213171631 SLC2012X 00643169680074 213171634 SLC3020X 00643169680340 213165102 SLC2515X 00643169680210 213171632 SLC2020X 00643169680098 213171630 SLC2510X 00643169680197 213171635 SLC4010X 00643169680517 213164951 SLC3015X 00643169680333 213171627 SLC2530X 00643169680241 213171629 SLC2520X 00643169680227 213171633 SLC2020X 00643169680098 213180121 SLC2015X 00643169680081 213180123 SLC3530X 00643169680463 213164952 SLC3520X 00643169680449 213158198 SLC1520X 00643169680043 213171628 SLC2515X 00643169680210 213180122 SLC2520X 00643169680227 213180124 SLC2012X 00643169680074 213186992 SLC2015X 00643169680081 213186995 SLC2512X 00643169680203 213186987 SLC2515X 00643169680210 213186989 SLC3012X 00643169680326 213186990 SLC2520X 00643169680227 213186993 SLC2020X 00643169680098 213186991 SLC3020X 00643169680340 213186994 SLC4012X 00643169680524 213186988 SLC2015X 00643169680081 213191140 SLC2020X 00643169680098 213196013 SLC2520X 00643169680227 213191136 SLC2025X 00643169680104 213191132 SLC2010X 00643169680067 213191134 SLC2510X 00643169680197 213196840 SLC2512X 00643169680203 213191139 SLC2515X 00643169680210 213191135 SLC22515X 00643169680159 213196019 SLC2015X 00643169680081 213196015 SLC2020X 00643169680098 213191133 SLC2030X 00643169680111 213196016 SLC3515X 00643169680432 213171626 SLC2520X 00643169680227 213196018 SLC2012X 00643169680074 213196017 SLC2515X 00643169680210 213196014 SLC3006X 00643169680302 213196012 SLC3015X 00643169680333 213191138 SLC2010X 00643169680067 213212325 SLC2020X 00643169680098 213212322 SLC2015X 00643169680081 213212212 SLC2520X 00643169680227 213212214 SLC27512X 00643169680265 213212209 SLC3015X 00643169680333 213212217 SLC1515X 00643169680036 213212324 SLC1520X 00643169680043 213191137 SLC2515X 00643169680210 213212215 SLC2012X 00643169680074 213212216 SLC2530X 00643169680241 213212326 SLC1512X 00643169680029 213212218 SLC2512X 00643169680203 213212321 SLC2525X 00643169680234 213212211 SLC3020X 00643169680340 213212320 SLC3520X 00643169680449 213212323 SLC4020X 00643169680548 213212210 SLC4015X 00643169680531 213212213 SLC3515X 00643169680432 213212219 SLC2515X 00643169680210 213241252 SLC2015X 00643169680081 213241254 SLC2520X 00643169680227 213241250 SLC2020X 00643169680098 213241259 SLC3020X 00643169680340 213241256 SLC2012X 00643169680074 213241261 SLC3015X 00643169680333 213241257 SLC2010X 00643169680067 213241263 SLC2512X 00643169680203 213241267 SLC3012X 00643169680326 213241265 SLC1520X 00643169680043 213241268 SLC1510X 00643169680012 213248778 SLC2015X 00643169680081 213248781 SLC2012X 00643169680074 213248783 SLC2010X 00643169680067 213248784 SLC2512X 00643169680203 213258525 SLC2020X 00643169680098 213248779 SLC2510X 00643169680197 213258527 SLC1515X 00643169680036 213274760 SLC2015X 00643169680081 213274759 SLC1520X 00643169680043 213258528 SLC2520X 00643169680227 213248782 SLC3015X 00643169680333 213248780 SLC2515X 00643169680210 213258526 SLC3010X 00643169680319 213248777 SLC1512X 00643169680029 213258524 SLC2030X 00643169680111 213274757 SLC2025X 00643169680104 213274754 SLC2520X 00643169680227 213274758 SLC3515X 00643169680432 213266359 SLC2012X 00643169680074 213274755 SLC2020X 00643169680098 213274756 SLC3020X 00643169680340 213274761 SLC2010X 00643169680067 213283554 SLC2506X 00643169680180 213283553 SLC3025X 00643169680357 213283552 SLC3030X 00643169680364 213283557 SLC3520X 00643169680449 213283555 SLC4010X 00643169680517 213283556 SLC3512X 00643169680425 213283551
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution. US Nationwide, including Puerto Rico; ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, BANGLADESH, BARBADOS, BELGIUM, BOSNIA AND HERZEGOWINA, BRAZIL, BULGARIA, CANADA, CHINA, COLOMBIA, COSTA RICA, CROATIA, CZECH REPUBLIC, DOMINICAN REPUBLIC, ESTONIA, FRANCE, GERMANY, GREAT BRITAIN, GREECE, GUADELOUPE, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KOREA, REPUBLIC OF KOREA, LATVIA, LEBANON, LIECHTENSTEIN, LITHUANIA, MALAYSIA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NICARAGUA, NIGERIA, NORWAY, OMAN, PAKISTAN, PAPUA NEW GUINEA, PHILIPPINES, POLAND, PORTUGAL, REUNION, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVAKIA (SLOVAK REPUBLIC), SLOVENIA, SOUTH AFRICA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM and VIET NAM
  • Description du dispositif
    Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.
  • Manufacturer
    Medtronic Vascular Galway DBA Medtronic Ireland
  • 1 Event

Fabricant

Medtronic Vascular Galway DBA Medtronic Ireland
  • Adresse du fabricant
    Medtronic Vascular Galway DBA Medtronic Ireland, Parkmore Business Park West, Galway Ireland
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA