Heartware, Inc.: Medical Device Recall in 2021 - (Recall #: Z-2478-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Medtronic HVAD Pump Implant Kits

Product Classification:

Class II

Date Initiated: August 6, 2021

Date Posted: September 22, 2021

Recall Number: Z-2478-2021

Event ID: 88541

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 11851 (potentially active, US); 1995 (active, US)

Code Information:

Product Numbers: 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU - all serial numbers

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated