TIGERPAW System II, Part number C-TP-1507 (7 connector) The TigerPaw System II is an implantable occlusion Fastener to b
FDA device recall Z-1461-2015 · posted 2015-04-23 · Terminated
Recall details
- Recalling firm
- Laax, Inc.
- 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.
- Action taken
- 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-(973)-396-3607. If you have acted as a distributor for the TIGERPAW System product II, immediately contact those accounts, advise them of the recall situationa and have them return all stock to you. Your Marquet Medical System USA Sales Representative will contact you to assist with the return of any product. If you have any additional questions, contact your local Maquet Medical Systems USA Sales Representative or our Customer Service at 1-888-880-2874 (6:00 AM - 5:00 PM PST).
- Root cause
- Unknown/Undetermined by firm
- Status
- Terminated
- Product code
- GDW
- Quantity affected
- ~ 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, Q
- Date initiated
- 2015-03-25
- Date posted
- 2015-04-23
- Date terminated
- 2017-03-17
- Location
- Livermore, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TIGERPAW SYSTEM II (K111064) | Laax, Inc. | 2011-05-18 |