Recall record at a glance
| Official record | Z-1462-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class I |
| FDA record status | Terminated |
| Recalling firm | Laax, Inc. |
| Report date | Apr 29, 2015 |
| Recall initiation date | Mar 25, 2015 |
| Quantity | ~4,154 units distributed in US - both part numbers |
| Location | Livermore, CA, United States |
Official product description
TIGERPAW System II, Part number C-TP-1509 (9 connector) The TigerPaw System II is an implantable occlusion Fastener to be placed on the Ostium of the Left Atrial Appendage (LAA).
Why the product was recalled
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.
Distribution information
Worldwide Distribution: US (nationwide) and countries of:Australia, Bahrain, Belgium, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Ireland, Israel, Italy Netherland, Norway, Poland, Qatar, Slovenia, Spain, Saudi Arabia, Sweden, Switzerland, Turkey and United Kingdom.
How to read the classification
FDA Class I indicates a situation in which there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. The classification shown here comes directly from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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