Laax TigerPaw System II Implantable Occlusion Fastener Recalled for Tissue Tearing
Laax, Inc. is recalling the TigerPaw System II implantable occlusion fastener due to field reports of possible tissue tearing and bleeding during use.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source describes 'possible tissue tearing on left atrial wall and bleeding,' which constitutes significant injury reports, meeting the criteria for a Severe (4) rating.
Plain-English summary
Laax, Inc. is recalling the TIGERPAW System II, an implantable occlusion fastener used to be placed on the Ostium of the Left Atrial Appendage (LAA). The recall involves part number C-TP-1507 (7 connector) and all serial numbers/lots. Approximately 4,154 total units are in the US, with worldwide distribution including the US, Australia, and various European and Middle Eastern countries.
The recall was initiated due to an increase in field reports involving issues with the device. These reports indicate possible tissue tearing on the left atrial wall and bleeding during use. The source text notes that these issues may or may not be caused by incomplete closure of the TigerPaw System II fastener.
Healthcare providers and patients who have received this device should contact Laax, Inc. for further instructions. The source text does not specify a particular action for consumers beyond the recall notice itself, but standard medical device recall procedures typically involve contacting the manufacturer or the implanting physician.
The recalled product
- 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).
- Manufacturer
- Laax, Inc.
- Hazard
- Affected units
- 4,154
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Part number C-TP-1507 (7 connector) All serial numbers/lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Laax, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Laax, Inc.
See all →- CriticalLaax Recalls TIGERPAW System II Implantable Occlusion Fasteners
FDA (Devices) · 2015-04-29
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