Device recall
Z-1099-2026: CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag…
FDA device recall · Class II · Thoratec LLC
Key facts
| Recall number (Z-number) | Z-1099-2026 |
|---|---|
| Recall event | 97784 |
| Product | CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag RVAD HDE KIT, REF: 104318; CentriMag Pre-connected Pack, REF: CMAEK00; CentriMag VAD KIT, REF: 201-51006, 201-51007, 201-90001 201-90001T; Blood Pump with CentriMag Acute Circulatory Support System for ECMO, REF: CMAEK01… |
| Product code | QNR |
| Recalling firm | Thoratec LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K222038 |
| FEI number | 2916596 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database