TandemHeart pump is assembled into kits: ProtekDuo Kit — Class II medical device recall Z-1951-2020
Terminated recall by Cardiac Assist, Inc, reported 2020-05-20, distributed nationwide. Failure to prime due to an assembly error
| Recall number | Z-1951-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardiac Assist, Inc, Pittsburgh, PA, United States |
| Recall initiated | 2020-03-06 |
| Classified | 2020-05-11 |
| Reported by FDA | 2020-05-20 |
| Terminated | 2020-11-20 |
| Distributed | Nationwide (US) |
| Quantity | 38 |
| Serial numbers | 00142569, 00142570, 00142571, 00142572, 00142573, 00142574, 00142575, 00142576, 00142592, 00142593, 00142594, 00142595, 00142597, 00142598, 00142600, 00142601, 00142664, 00142665, 00142666, 00142668, 00142669, 00142670, 00142671, 00142672, 00142673 and 13 more |
Product
TandemHeart pump is assembled into kits: ProtekDuo Kit - DL29, Product: 5720-2916 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion system.
Reason for recall
Failure to prime due to an assembly error
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-1951-2020. 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.