Z-1336-2021Class I

Medtronic HVAD Controller, Product Numbers: 1400, 1401, 1401AU, 1401BR, 1401CA, 1401CH, 1401DE, 1401GB...

Name: Z-1336-2021 Medtronic HVAD Controller, Product Numbers: 1400, 1401, 1401AU, 1401BR, 1401CA, 1401CH, 1401DE, 1401GB...
Creator: Heartware, Inc.
Published: 2021-02-26
License: https://open.fda.gov/license/

HeartWare, Inc. / initiated 2021-02-26 / Open, Classified / root cause: design

FDA source

Heartware, Inc. began a recall of Medtronic HVAD Controller, Product Numbers: 1400, 1401, 1401AU, 1401BR, 1401CA, 1401CH, 1401DE, 1401GB, 1401IL, 1401IN, 1401IT, 1401JP, 1401US, 1403US, 1407AR... on 2021-02-26. FDA classified it as Class I and gives the reason as "There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller ports when inserting the...". 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-1336-2021
Classification: Class I
Status: Open, Classified
Initiated: 2021-02-26
Posted: 2021-04-06
Recalling firm: HeartWare, Inc.
Product: Medtronic HVAD Controller, Product Numbers: 1400, 1401, 1401AU, 1401BR, 1401CA, 1401CH, 1401DE, 1401GB, 1401IL, 1401IN, 1401IT, 1401JP, 1401US, 1403US, 1407AR, 1407AU, 1407BR, 1407CA, 1407CA-CLIN, 1407CH, 1407DE, 1407GB, 1407IL, 1407IN, 1407IT, 1407JP, 1407KR
Product code: DSQ Ventricular (Assist) Bypass
Reason for recall: There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alarm Adapter, and HVAD Monitor data cables to cause damage to the HVAD Controller ports when inserting the cables into the Controller ports, due to wear from misalignment of the cables to the port.
Root cause tag: design
FDA root cause: Device Design
Action: The firm issued a Medical Device Notice to its consignees on 02/26/2021 by letter delivered via UPS 2-day delivery. The letter explained the issue and directed the physician to review the patient management recommendations on the frequency of of inspecting the HVAD Controller, HVAD Controller power cables, and HVAD Monitor data cables. For questions regarding this material, please contact your Medtronic Field Representative.
Quantity in commerce: 56,018 units (28,449 US)
Distribution: Worldwide
Product codes and lots: All lot codes

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1336-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1336-2021	Class I	Ongoing	Voluntary: Firm initiated	2021-04-14	2021-04-06
Z-1337-2021	Class I	Ongoing	Voluntary: Firm initiated	2021-04-14	2021-04-06
Z-1338-2021	Class I	Ongoing	Voluntary: Firm initiated	2021-04-14	2021-04-06
Z-1339-2021	Class I	Ongoing	Voluntary: Firm initiated	2021-04-14	2021-04-06
Z-1340-2021	Class I	Ongoing	Voluntary: Firm initiated	2021-04-14	2021-04-06
Z-1341-2021	Class I	Ongoing	Voluntary: Firm initiated	2021-04-14	2021-04-06

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)