Z-2478-2021Class II

Medtronic HVAD Pump Implant Kits

Name: Z-2478-2021 Medtronic HVAD Pump Implant Kits
Creator: Heartware, Inc.
Published: 2021-08-06
License: https://open.fda.gov/license/

HeartWare, Inc. / initiated 2021-08-06 / Open, Classified / root cause: design

FDA source

Heartware, Inc. began a recall of Medtronic HVAD Pump Implant Kits on 2021-08-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2478-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-08-06
Posted: 2021-09-16
Recalling firm: HeartWare, Inc.
Product: Medtronic HVAD Pump Implant Kits
Product code: DSQ Ventricular (Assist) Bypass
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.
Root cause tag: design
FDA root cause: Device Design
Action: Beginning 10-Aug-2021 (US), and no later than 17-Aug-2021 (OUS), Medtronic initiated a Global notification to inform HVAD clinicians (following physicians and VAD Coordinators at HVAD accounts) who are currently treating patients implanted with the HVAD system about the potential for difficulty in pulling back the HVAD Pump Driveline cover for drivelines that have received a strain relief repair. In the United States, beginning 10-Aug-2021, an Urgent Medical Device Notice, was delivered to following physicians and VAD Coordinators, who are currently caring for an HVAD patient, via UPS 2-day delivery as well as through verbal and in person follow ups from the Medtronic field staff. Also, in the United States, on 17-Aug-2021, Medtronic sent a notification to active HVAD Patients in the U.S. according to their registered contact information via UPS 2-day delivery to make them aware of the potential for this issue and to reinforce precautions in the IFU and Patient Manual cautioning against selfrepairing the HVAD equipment. Outside of the United States, beginning 10-Aug-2021 and no later than 17-Aug-2021, a formal FCA notification will be delivered to VAD Coordinators and following physicians who according to Medtronic records are treating patients implanted with an HVAD system. This letter will be delivered using locally approved methods. Confirmation of the communication will be received via locally approved methods.
Quantity in commerce: 11851 (potentially active, US); 1995 (active, US)
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
Product codes and lots: Product Numbers: 1100, 1101, 1102, 1103, 1104, 1104JP, 1205, and MCS1705PU - all serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2478-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2478-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-09-22	2021-09-16

Product code DSQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)