FDA Device recall Z-1461-2015
TIGERPAW System II, Part number C-TP-1507 (7 connector) The TigerPaw System II is an implantable occlusion Fastener to be placed on the Ost…
- FDA Device
- Class I
- terminated
- Published 2015-04-29
On 2015-04-29 the FDA classified a Class I recall of TIGERPAW System II, Part number C-TP-1507 (7 connector) The TigerPaw System II is an implantable occlusion Fastener to be placed on the Ost… by Laax, citing increase of field reports involving issues with the TIGERPAW System II resulting in possible tissue tearing on left atrial wall and bleeding during use of the device, which may or….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1461-2015 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2015-03-25 |
| Published | 2015-04-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Laax |
| Distribution | US |
Product
TIGERPAW System II, Part number C-TP-1507 (7 connector) The TigerPaw System II is an implantable occlusion Fastener to be placed on the Ostium of the Left Atrial Appendage (LAA).
Reason
Increase of field reports involving issues with the TIGERPAW System II resulting in possible tissue tearing on left atrial wall and bleeding during use of the device, which may or may not be caused by incomplete closure of the TigerPaw System II fastener.
Identifiers
| code_info | Part number C-TP-1507 (7 connector) All serial numbers/lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1461-2015%22
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