Drug recall
CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of…
FDA recall event 83895 · Class I · Thoratec Switzerland GMBH
Key facts
| Event ID | 83895 |
|---|---|
| Recall numbers | Z-0221-2020 |
| Recalling firm | Thoratec Switzerland GMBH |
| Product type | Devices |
| Products | CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the CentriMag Extracorporeal Blood Pumping System. |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Reports have been received of the CentriMag Systems experiencing motor and pump issues resulting from electromagnetic interference (EMI). |
| Initiation date | Aug 22, 2019 |
| Report date | Nov 6, 2019 |
| Termination date | Apr 26, 2024 |
| City | Zurich |
| Country | Switzerland |
| FEI number | 3003306248 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: