CLASS II ONGOING Device recall · Reported 28 Jun 2023 · FDA Enforcement Report
Ventricular Assist Device System recalled by Heartware
Heartware is recalling Ventricular Assist Device System, distributed nationwide in the US. The recall was initiated on 16 May 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1993-2023
- FDA event ID
- 92350
- Recalling firm
- Heartware, Miami Lakes, FL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 May 2023
- FDA classified
- 22 Jun 2023
- Reported
- 28 Jun 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Patient Monitors
Timeline
| 16 May 2023 | Recall initiated by company | |
| 22 Jun 2023 | Classified by FDA | +37 days |
| 28 Jun 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Medtronic has identified that the logfiles downloaded from the recently updated Model 1521 monitors (Serial Numbers: MON4xxxxxx for OUS and MON5xxxxxx for US), are unable to be processed by the Autologs web portal.
Product as listed by the FDA
HeartWare Ventricular Assist Device System. a) Monitor 1521US Explore Tech, b) Monitor 1521GB Explore Tech, c) Monitor 1521IL Explore Tech, d) Monitor 1521DE Explore Tech
Where it was distributed
Worldwide - US Nationwide distribution in the states of TX, MO, VA, and the countries of Bahrain, UK.
Questions about this recall
Why was it recalled?
Medtronic has identified that the logfiles downloaded from the recently updated Model 1521 monitors (Serial Numbers: MON4xxxxxx for OUS and MON5xxxxxx for US), are unable to be processed by the Autologs web portal.
Which lots are affected?
a) Model Number 1521US, GTIN 00888707009256, Serial/Lot Numbers: MON500010, MON500012, MON500016, MON500028, MON500026, MON500005, MON500006, MON500007. b) Model Number 1521GB, GTIN 00888707006521, Serial/Lot Numbers: MON400039, MON400050, MON400051, MON400052, MON400053, MON400054, MON400061. c) Model Number 1521IL, GTIN 00888707010108, Serial/Lot Number: MON400017. d) Model Number 1521DE, GTIN 00888707010085, Serial/Lot Numbers: MON400045, MON400021, MON400013.
Where was it sold?
Worldwide - US Nationwide distribution in the states of TX, MO, VA, and the countries of Bahrain, UK.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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