medical Class II Updated 2021-09-22

Heartware, Inc. recalls Medtronic HVAD Pump Implant Kits

Recalled Product

Medtronic HVAD Pump Implant Kits

Hazard / Issue

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.

Issued by

FDA

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, 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
Lot/Code Info: Product Numbers: 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU - all serial numbers
View official government recall

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