Medtronic Custom Perfusion Systems, indicated for use in the extracorporeal circuit during cardiopulmonary bypass (CPB)
FDA device recall Z-0535-2018 · posted 2018-01-30 · Terminated
Recall details
- Recalling firm
- Medtronic Perfusion Systems
- Reason for recall
- Medtronic custom perfusion tubing packs contain Terumo OPS valves that were recalled due to a lack of flow through the valve.
- Action taken
- In response to an Urgent Safety Alert issued by Terumo Cardiovascular Systems (CVS) Medtronic initiated their safety alert verbally to their direct consignees on 10/23/2017, providing them with a copy of the Terumo Safety Alert dated 06/27/2017. The firm followed this action with a letter on 1/3/18 in which they stated that the action by Terumo CVS was changed to a recall, and , in response, Medtronic was following up as a recall and requested the products be returned.
- Root cause
- Component change control
- Status
- Terminated
- Product code
- DWF
- Quantity affected
- 2914 units
- Distribution
- DE, IA, CA and Japan
- Date initiated
- 2018-01-03
- Date posted
- 2018-01-30
- Date terminated
- 2020-10-05
- Location
- Brooklyn Park, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Tubing Pack (K171308) | Medtronic, Inc. | 2017-06-02 |