Reported Sep 22, 2021 · Ongoing
Medtronic HVAD Pump Implant Kits
Heartware, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Heartware, Inc. · 14400 Nw 60th Ave · Miami Lakes, FL · 33014-2807
Is this the product you have?
- Medtronic HVAD Pump Implant Kits
- Lot codes and dates
- Product Numbers
110011011102110311041104JP1205and MCS1705PU - all serial numbers
- Product Numbers
- Amount recalled
- 11851 (potentially active, US); 1995 (active, US)
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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