Recall Z-2478-2021 ยท DSQ Ventricular (Assist) Bypass
Heartware, Inc.
Medtronic HVAD Pump Implant Kits
| Date | Aug 6, 2021 |
| Status | Open, Classified |
| Reason | There is more force required to slide the driveline cover (boot cover) away from the connector after completion of a Driveline Strain Relief Repair than over an unrepaired strain relief. This may lead to difficulty in pulling back the driveline cover when attempting to access the Driveline connector during a controller exchange. Additionally, sliding the driveline cover over a strain relief repair may compromise the repair. |
| Root cause | Device Design |
| Action | Beginning 10-Aug-2021 (US), and no later than 17-Aug-2021 (OUS), Medtronic initiated a Global notification to inform HVAD clinicians (following physicians and VAD Coordinators at HVAD accounts) who are currently treating patients implanted with the HVAD system about the potential for difficulty in pulling back the HVAD Pump Driveline cover for drivelines that have received a strain relief repair. In the United States, beginning 10-Aug-2021, an Urgent Medical Device Notice, was delivered to following physicians and VAD Coordinators, who are currently caring for an HVAD patient, via UPS 2-day d |
| Quantity | 11851 (potentially active, US); 1995 (active, US) |
| Distribution | Distribution throughout the US. Also distribution in ARGENTINA Armenia, Australia, Austria, BELGIUM, BRAZIL, CANADA, CHILE, Colombia, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, Germany, GREECE HONG KONG, HUNGARY, INDIA, ISRAEL, Italy, JAPAN, Kazakhstan, Korea, KUWAIT, Latvia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.