Device Recall Boston Scientific Synchro 14 Guidewire

  • Modèle / numéro de série
    Material # M00313510: lot/use by dates: B17282 7/31/2011
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including CA, CO, IN, MD, MI, OR, TX, and VA and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Great Britian, Greece, Honduras, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Puerto Rico, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Korea, Sweden, Switzerland, Thailand, Tunisia, Turkey, and Ukraine.
  • Description du dispositif
    Boston Scientific brand Synchro.14" Guide Wire, 300 cm length, 35 cm tip; || Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119 || Product is distributed by Boston Scientific Corporation, || Fremont, CA || The Synchro guidewire series is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous intravascular techniques and procedures.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Boston Scientific Corporation, 47900 Bayside Pkwy, Fremont CA 94538-6515
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA

5 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Material # M00313010: lot/use by dates: B18331 11/30/2011  B18332 11/30/2011  B18333 11/30/2011  B18334 11/30/2011  B18335 11/30/2011  B18383 11/30/2011  B18384 11/30/2011  B18385 11/30/2011  B18386 11/30/2011  B18387 11/30/2011  B18388 11/30/2011  B18389 11/30/2011  B18544 12/31/2011  B18545 12/31/2011  B18546 12/31/2011  B18547 12/31/2011  B18548 12/31/2011  B18549 12/31/2011  B18650 12/31/2011  B18651 12/31/2011  B18652 12/31/2011  B18653 12/31/2011  B18654 12/31/2011  B18655 12/31/2011  B18656 12/31/2011  B18657 12/31/2011  B18843 1/31/2012  B18844 1/31/2012  B18845 1/31/2012  B18887 1/31/2012  B18888 1/31/2012  B18889 1/31/2012  B18890 1/31/2012  B18891 1/31/2012  B18897 1/31/2012  B18898 1/31/2012  B18899 1/31/2012  B18900 1/31/2012  B18901 1/31/2012  B18902 1/31/2012  B19094 2/29/2012  B19095 2/29/2012  B19106 2/29/2012  B19107 2/29/2012  B19108 2/29/2012  B19233 3/31/2012  B19235 3/31/2012  B19240 3/31/2012  B19298 3/31/2012  B19299 3/31/2012  B19389 3/31/2012  B19390 4/30/2012  B19454 4/30/2012  B19466 4/30/2012 .
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including CA, CO, IN, MD, MI, OR, TX, and VA and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Great Britian, Greece, Honduras, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Puerto Rico, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Korea, Sweden, Switzerland, Thailand, Tunisia, Turkey, and Ukraine.
  • Description du dispositif
    Boston Scientific brand Synchro.14" Guide Wire, 35 cm, tip; || Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119 || Product is distributed by Boston Scientific Corporation, || Fremont, CA || The Synchro guidewire series is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous intravascular techniques and procedures.
  • Manufacturer
  • Modèle / numéro de série
    Material # M00313020: lot/use by dates: B17208 7/31/2011  B17522 8/31/2011  B17594 9/30/2011  B17817 9/30/2011  B17853 9/30/2011  B18017 10/31/2011  B18107 10/31/2011  B18390 11/30/2011  B18550 12/31/2011  B18886 1/31/2012  B19069 2/29/2012
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including CA, CO, IN, MD, MI, OR, TX, and VA and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Great Britian, Greece, Honduras, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Puerto Rico, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Korea, Sweden, Switzerland, Thailand, Tunisia, Turkey, and Ukraine.
  • Description du dispositif
    Boston Scientific brand Synchro.14" Guide Wire, 45 cm, tip; || Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119 || Product is distributed by Boston Scientific Corporation, || Fremont, CA || The Synchro guidewire series is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous intravascular techniques and procedures.
  • Manufacturer
  • Modèle / numéro de série
    Material # M00313310: lot/use by dates: B17281 7/31/2011  B17595 9/30/2011  B18018 10/31/2011  B18336 11/30/2011  B18885 1/31/2012  B19068 2/29/2012  B19236 3/31/2012
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including CA, CO, IN, MD, MI, OR, TX, and VA and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Great Britian, Greece, Honduras, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Puerto Rico, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Korea, Sweden, Switzerland, Thailand, Tunisia, Turkey, and Ukraine.
  • Description du dispositif
    Boston Scientific brand Synchro.14" Guide Wire, 300 cm length, 35 cm tip; || Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119 || Product is distributed by Boston Scientific Corporation, || Fremont, CA || The Synchro guidewire series is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous intravascular techniques and procedures.
  • Manufacturer
  • Modèle / numéro de série
    Material # M00313320: lot/use by dates: B17854 9/30/2011  B19301 3/31/2012
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including CA, CO, IN, MD, MI, OR, TX, and VA and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Great Britian, Greece, Honduras, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Puerto Rico, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Korea, Sweden, Switzerland, Thailand, Tunisia, Turkey, and Ukraine.
  • Description du dispositif
    Boston Scientific brand Synchro.14" Guide Wire, 300 cm length, 45 cm tip; || Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119 || Product is distributed by Boston Scientific Corporation, || Fremont, CA || The Synchro guidewire series is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous intravascular techniques and procedures.
  • Manufacturer
  • Modèle / numéro de série
    Material # M00313410: lot/use by dates: B17209 7/31/2011  B19510 4/30/2012
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA including CA, CO, IN, MD, MI, OR, TX, and VA and the countries of Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Egypt, Finland, France, Georgia, Germany, Great Britian, Greece, Honduras, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Lithuania, Malaysia, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Puerto Rico, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Korea, Sweden, Switzerland, Thailand, Tunisia, Turkey, and Ukraine.
  • Description du dispositif
    Boston Scientific brand Synchro.14" Guide Wire, 200 cm length, 35 cm tip; || Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119 || Product is distributed by Boston Scientific Corporation, || Fremont, CA || The Synchro guidewire series is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous intravascular techniques and procedures.
  • Manufacturer