Events

Rappel de Device Recall Medtronic DPL

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Medtronic Inc. Cardiac Rhythm Disease Management.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    64417
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0908-2013
  • Date de mise en oeuvre de l'événement
    2013-02-19
  • Date de publication de l'événement
    2013-03-05
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-11-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116100
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    venous cannula - Product Code DWF
  • Cause
    Potential for uncharacteristically rough metal edges to occur along the inner diameter of the metal tip side ports of the cannula.
  • Action
    Consignees were sent a Medtronic "Urgent Medical Device Recall" letter dated February 19, 2013. The letter described the problem and the product involved in the recall. Advised consignees to quarantine affected product, and return the product to Medtronic. Requested consignees the complete and return the attached Customer confirmation certificate. If product has been forwarded to another facility, requested consignees to notify the facility of the issue.

Device

Device Recall Medtronic DPL
  • Modèle / numéro de série
    Model Catalog# Lot 67312 6731210NO 2012090293 67312 6731210NO 2012090294 67312 6731210NO 2012090337 67312 6731210NO 2012100039 67312 6731210NO 2012100086 67312 6731210NO 2012100087 67312 6731210NO 2012100161 67312 6731210NO 2012110326 67312 6731210NO 2012110767 67312 6731210NO 2012110899 67312 6731210NO 2012111721 67314 6731410NO 2012090416 67314 6731410NO 2012090435 67314 6731410NO 2012090571 67314 6731410NO 2012090572 67314 6731410NO 2012100040 67314 6731410NO 2012100041 67314 6731410NO 2012100107 67314 6731410NO 2012101346 67314 6731410NO 2012110007 67314 6731410NO 2012110008 67314 6731410NO 2012110327 67314 6731410NO 2012111419 67314 6731410NO 2012111420 67314 6731410NO 2012120019 67316 6731610NO 2012090239 67316 6731610NO 2012090389 67316 6731610NO 2012090854 67316 6731610NO 2012091024 67316 6731610NO 2012110030 67316 6731610NO 2012110144 67316 6731610NO 2012110394 67316 6731610NO 2012110395 67316 6731610NO 2012110396 67318 67318 2012110850 67318 67318 2012110851 67318 67318 2012111013 67318 67318 2012111789 67318 67318 2012120328 67318 67318 2012120330 67318 67318 2013010932 67318 67318 2013010933 67318 67318 2013011226 67320 67320 2012121379 67320 67320 2012121629 67320 67320 2013010002 67320 67320 2013010105 69312 6931210NO 2012090236 69312 6931210NO 2012110010 69312 69312INK 2012090296 69312 69312INK 2012100905 69312 69312INK 2012110251 69312 69312INK 2012110252 69314 6931410NO 2012090855 69314 6931410NO 2012091222 69316 6931610NO 2012090240 69318 69318 2012111225 69318 69318 2013010966 69320 69320 2012121408 69320 69320 2013010003 69322 69322 2012111723 69322 69322 2012120118 69322 69322 2012120513 69322 69322 2013010812 69322 69322 2013010935 69324 69324 2012121060 69324 69324 2012121061 69324 69324 2012121062 69324 69324 2012121148 69324 69324 2012121149 69324 69324 2012121362 69328 69328 2012110184 69328 69328 2012120660 69328 69328 2012120661 69328 69328 2012120992 69328 69328 2012121004 69328 69328 2012121005 69328 69328 2012121006 69328 69328 2012121150 69328 69328 2012121192 69328 69328 2012121193 69328 69328 2012121364 69328 69328 201301C189 69331 69331 2012121063 69331 69331 2012121064 69331 69331 2012121151 69331 69331 2012121382 69331 69331 2013010224 69331 69331 2013010437 69331 69331 2013010438 69331 69331 2013010510 69331 69331 2013010511 CB67314 CB67314 206409412 CB67318 CB67318 206513557 CB67318 CB67318 206642303
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution, including USA nationwide, Albania, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Kazakhstan, Korea, Libya, Lithuania, Macedonia, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, and Viet Nam.
  • Description du dispositif
    Medtronic DPL Single Stage Venous Cannula with Metal Tip, used in cardiopulmonary bypass procedures. || Model numbers: 67312; 67314; CB67314; 67316; 67318; CB67318; 67320; 69312; 69314; 69316; 69318; 69320; 69322; 69324; 69328; 69331.
  • Manufacturer
    Medtronic Inc. Cardiac Rhythm Disease Management

Manufacturer

Medtronic Inc. Cardiac Rhythm Disease Management
  • Adresse du fabricant
    Medtronic Inc. Cardiac Rhythm Disease Management, 8200 Coral Sea St NE, Saint Paul MN 55112-4391
  • 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