FDA Device recall Z-0221-2020
CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the CentriMag Extracorporeal Bl…
- FDA Device
- Class I
- terminated
- Published 2019-11-06
On 2019-11-06 the FDA classified a Class I recall of CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the CentriMag Extracorporeal Bl… by Thoratec Switzerland, citing reports have been received of the CentriMag Systems experiencing motor and pump issues resulting from electromagnetic interference (EMI).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0221-2020 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2019-08-22 |
| Published | 2019-11-06 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Thoratec Switzerland |
| Distribution | US |
Product
CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the CentriMag Extracorporeal Blood Pumping System.
Reason
Reports have been received of the CentriMag Systems experiencing motor and pump issues resulting from electromagnetic interference (EMI).
Identifiers
| code_info | U.S. Model 102956 UDI: 07640135140078. Motor serial numbers between L05333-0001 and L06608-0024 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0221-2020%22
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