Reported Jul 3, 2024 · Ongoing
2nd Generation CentriMag Primary Console, REF: 201-90401, 201-90701, 201-90411, 201-90421, 201-30300, L201-90401,…
Thoratec Switzerland GmbH
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Thoratec Switzerland GMBH · Technoparkstrasse 1 · Zurich · N/A
Is this the product you have?
- 2nd Generation CentriMag Primary Console
- REF201-90401, 201-90701, 201-90411, 201-90421, 201-30300, L201-90401, L201-90411, L201-90421, part of the CentriMag Circulatory Support System
- Lot codes and dates
- REF/Serial Number or Range201-30300/ L00610-0004-L06786-0002 201-90401/ 19234129-20119751 and L00610-0011-L08005-0001 201-90411/19234128-20190463 and L03849-0004-L08002-0001 201-90421/19474336-19606873 and L04780-0005-L07601-0001 201-90701/ 19415572 and L03774-0007-L08007-0001 L201-90401/ L00694-0006-L06579-0004 and L201-90401 L201-90411/ 19258710-19605455 and L01627-0007-L07980-0001 L201-90421/
- L01716-0010-L06482-0005 UDI-DI
0764013514068907640135140726076401351407020764013514071907640135140856054150670372820764013514089407640135149019076401351490020764013514070207640135140719
- Amount recalled
- 3,425
Where it was sold
Why it was recalled
Due to a component change, the console part of a circulatory support system may not conform to the IEC 61000-4-5 standard, so if subjected to a power surge above 1.8kV and up to 2.0 kV, the console may shut down completely without alarm, pumping would cease, and the patient would have to be switched to a backup circulatory support system.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Thoratec Switzerland GmbH recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.