Recall Z-2215-2024 ยท DSQ Ventricular (Assist) Bypass
Thoratec Switzerland GMBH
2nd Generation CentriMag Primary Console, REF: 201-90401, 201-90701, 201-90411, 201-90421, 201-30300, L201-90401, L201-90411, L201-90421, part of the CentriMag Circulatory Support System
| Date | Jun 27, 2024 (initiated May 22, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Process control |
| Action | On 5/22/24, correction notice distribution started. Customers were asked to do the following: If the console shuts down without alarms or alerts present, follow Instruction for Use (IFU) for Console and Motor malfunction as described in the Section Emergency / Troubleshooting , and switch to a backup console, which must be prepared as required backup components in the immediate vicinity. As stated in the IFU these backup systems should have a battery charge sufficient for at least one hour of operation, be connected to wall power, and be powered off. Note: When the backup console is put in |
| Quantity | 3,425 |
| Distribution | Worldwide - US Nationwide distribution included in the states of CA, PA, FL, IL, NY, AR, GA, WI, AZ, TN, TX, NC, MT, VA, MA, NJ, NE, WV, ME, OK, CO, OH, KC, WA, IN, CT, MI, OR, ID, MO, SC, KY, LA, NM, NV, VT, IA, MD and the countries of ALGERIA, AUSTRALIA, AUSTRIA, BANGLADESH, BULGARIA, CANADA, CAYM |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.