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Heartware, Inc. Recall 88541

Description: Medtronic HVAD Pump Implant Kits

Heartware, Inc. Recall 88541 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-2478-2021
Event ID88541
Event DescriptionMedtronic HVAD Pump Implant Kits
Product TypeDevices
DistributionDistribution 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
Quantity11851 (potentially active, US); 1995 (active, US)
Recall ReasonThere 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.
Device Classification20210922
Device Code InfoProduct Numbers: 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU - all serial numbers
Center Classification Date20210916
Recall Initiation Date20210806
Recalling FirmHeartware, Inc.
Initial Notification Letter
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