TIGERPAW System II — Class I medical device recall Z-1461-2015
Terminated recall by Laax, Inc., reported 2015-04-29, distributed nationwide. Increase of field reports involving issues with the TIGERPAW System II resulting in possible tissue tearing on
| Recall number | Z-1461-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Laax, Inc., Livermore, CA, United States |
| Recall initiated | 2015-03-25 |
| Classified | 2015-04-23 |
| Reported by FDA | 2015-04-29 |
| Terminated | 2017-03-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, BH, CH, CZ, DE, DK, ES, FI, FR, GB, HK, IE, IL, IT, NO, PL, QA, SA, SE, SI, TR |
| Quantity | 4,154 units |
| Model numbers | C-TP-1507 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1461-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.