CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the CentriMa
FDA device recall Z-0221-2020 · posted 2019-10-30 · Terminated
Recall details
- Recalling firm
- Thoratec Switzerland GMBH
- Reason for recall
- Reports have been received of the CentriMag Systems experiencing motor and pump issues resulting from electromagnetic interference (EMI).
- Action taken
- A recall letter dated August 22, 2019 was issued on Abbott letterhead and was delivered by field representative visits beginning August 22, 2019 for the U.S. consignees. Foreign consignees were notified with a letter dated August 22, 2019 containing the same content but OUS model numbers and OUS contact information. Depending on the requirements by the local regulator, the letters may have been delivered by a field representative or via certified mail. The letter identified the affected product, problem and actions to be taken.
- Root cause
- Process change control
- Status
- Terminated
- Product code
- KFM
- Quantity affected
- 664 units (381 U.S. and 283 OUS)
- Distribution
- Distribution was nationwide. There was government distribution, but no military distribution. Foreign distribution was made to Canada, Chile, Colombia, Costa Rica, Denmark, Dominican Republic, Finland
- Date initiated
- 2019-08-22
- Date posted
- 2019-10-30
- Date terminated
- 2024-04-26
- Location
- Zurich, Switzerland
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100 (K020271) | Levitronix, LLC | 2003-03-25 |