Recall Z-0221-2020 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Thoratec Switzerland GMBH
CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the CentriMag Extracorporeal Blood Pumping System.
| Date | Oct 30, 2019 (initiated Aug 22, 2019) |
| Status | Terminated |
| Reason | Reports have been received of the CentriMag Systems experiencing motor and pump issues resulting from electromagnetic interference (EMI). |
| Root cause | Process change control |
| Action | 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. |
| Quantity | 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, France, Hong Kong, India, Israel, Italy, Liechtenstein, Mexico, Netherlands, Portugal, Qatar, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020271 | LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100 Levitronix, LLC, Mar 25, 2003 |