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Heartware, Inc. recalls Medtronic HVAD Pump Implant Kits
Recalled September 22, 2021 · FDA recall Z-2478-2021 · Heartware
Hazard
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. · FDA Class II
Units
11851 (potentially active, US); 1995 (active, US)
Sold at
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, LEBANON, LITHUANIA, LUXEMBOURG, Macedonia, MALAYSIA, NETHERLANDS, NEW ZEALAND, NORWAY, Poland, ROMANIA, SAUDI ARABIA, Serbia, Singapore, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, Taiwan, TURKEY, Ukraine, United Arab Emirates, United Kingdom, VIETNAM
Description
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.
Product
Medtronic HVAD Pump Implant Kits
Manufacturer(s)
Heartware, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →