Data Foundry

Medical device recalls 2021

Medtronic HVAD Monitor Data Cable — Class I medical device recall Z-1339-2021

Ongoing recall by Heartware, Inc., reported 2021-04-14. There is the potential for the Controller power cables (AC Adapter, DC Adapter, and Battery cables), HVAD Alar

Recall numberZ-1339-2021
Product typeMedical device
ClassificationClass I
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmHeartware, Inc., Miami Lakes, FL, United States
Recall initiated2021-02-26
Classified2021-04-06
Reported by FDA2021-04-14

Product

Medtronic HVAD Monitor Data Cable, Product Number: 1575

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1339-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.