Laax Recalls TIGERPAW System II Implantable Occlusion Fasteners
Laax, Inc. is recalling TIGERPAW System II implantable fasteners due to reports of 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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA has classified this recall as Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Laax, Inc. is recalling the TIGERPAW System II, an implantable occlusion fastener designed to be placed on the Ostium of the Left Atrial Appendage (LAA). The recall involves part number C-TP-1509 (9 connector) and all serial numbers and lots. Approximately 4,154 units were distributed in the United States and internationally.
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.
The FDA has classified this recall as Class I. Healthcare providers and patients should contact Laax, Inc. for further instructions regarding the affected devices.
The recalled product
- Product
- 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).
- 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-1509 (9 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 →- SevereLaax TigerPaw System II Implantable Occlusion Fastener Recalled for Tissue Tearing
FDA (Devices) · 2015-04-29
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