TANDEM LIFE LivaNova LIFESPARC Controller; Controller and Accessories Model 5900-0000; Controller Only Model 5900-0001.
FDA device recall Z-1763-2022 · posted 2022-09-23 · Terminated
Recall details
- Recalling firm
- Cardiac Assist, Inc
- Reason for recall
- Critical Failure of the LifeSPARC controller when the software freezes or crashes and the screen does not display data.
- Action taken
- On July 21, 2022, the recalling firm notified impacted customers through mailed letters. Customers were instructed to use Operations Manual revision 15 and to discard all previous revisions of the Operations Manuals.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- DWA
- Quantity affected
- 723 units (484 currently in field)
- Distribution
- US Nationwide distribution.
- Date initiated
- 2022-07-21
- Date posted
- 2022-09-23
- Date terminated
- 2023-08-08
- Location
- Pittsburgh, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LifeSPARC Pump, LifeSPARC Controller (K183623) | Cardiacassist, Inc. | 2019-07-09 |