CLASS II ONGOING Device recall · Reported 8 Feb 2023 · FDA Enforcement Report
SynCardia Total Artificial Heart System (70CC) recalled
SynCardia Systems is recalling SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial, distributed nationwide in the US. The recall was initiated on 2 Nov 2022 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-1022-2023
- FDA event ID
- 91330
- Recalling firm
- SynCardia Systems, Tucson, AZ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 Nov 2022
- FDA classified
- 27 Jan 2023
- Reported
- 8 Feb 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 2 Nov 2022 | Recall initiated by company | |
| 27 Jan 2023 | Classified by FDA | +86 days |
| 8 Feb 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to tears reported tears in the cannula due to wear and tear stress.
Product as listed by the FDA
SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000
Where it was distributed
Worldwide distribution - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, FL, IA. IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, OK, PA, TN, TX, UT, VA, WA, and WI. The countries of Australia, Austria, Canada, Croatia, Finland, France, Germany, Greece, Israel, Italy, Kuwait, Lebanon, Lithuania, Macedonia, Poland, Russia, Saudi Arabia, Serbia, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
Nationwide AlabamaArkansasArizonaCaliforniaFloridaIowaIllinoisIndianaKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouriNorth CarolinaNebraskaNew JerseyNew YorkOhio
Questions about this recall
Is SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial recalled?
Yes. SynCardia Systems recalled SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial on 2 Nov 2022. The recall is Class II and its status is Ongoing. Recall number Z-1022-2023.
Why was it recalled?
Due to tears reported tears in the cannula due to wear and tear stress.
Which lots are affected?
SynCardia Total Artificial Heart System (70CC): 500101-001 SynCardia Total Artificial Heart System (50CC): 570500-000
Where was it sold?
Worldwide distribution - U.S. Nationwide distribution in the states of AL, AR, AZ, CA, FL, IA. IL, IN, KY, LA, MA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, OK, PA, TN, TX, UT, VA, WA, and WI. The countries of Australia, Austria, Canada, Croatia, Finland, France, Germany, Greece, Israel, Italy, Kuwait, Lebanon, Lithuania, Macedonia, Poland, Russia, Saudi Arabia, Serbia, Slovak Republic, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
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 21 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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