Recall Z-1461-2015 ยท GDW Staple, Implantable
Laax, Inc.
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).
| Date | Apr 23, 2015 (initiated Mar 25, 2015) |
| Status | Terminated |
| 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. |
| Root cause | Unknown/Undetermined by firm |
| Action | The firm, LAAx, Inc.on behalf of Maquet Medical Systems, sent an "URGENT MEDICAL DEVICE RECALL (Removal) IMMEDIATE ACTION REQUIRED " letter dated March 30, 2015 to all affected sites by express mail. The letter describers the product, problem and actions to be taken. The customers were instructed to examine your inventory immediately to determine if you have any TIGERPAW System II products; remove the products, quarantine them and place in a secure location; complete and return the MEDICAL DEVICE RECALL (Removal) RESPONSE FORM by e-mailing a scanned copy to:Tigerpaw2015@maquet.com or FAX to: 1 |
| Quantity | ~ 4,154 total units in US - both model numbers |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111064 | TIGERPAW SYSTEM II Laax, Inc., May 18, 2011 |