Z-1462-2015Class I

TIGERPAW System II, Part number C-TP-1509 (9 connector) The TigerPaw System II is an implantable occlusion...

Name: Z-1462-2015 TIGERPAW System II, Part number C-TP-1509 (9 connector) The TigerPaw System II is an implantable occlusion...
Creator: Laax, Inc.
Published: 2015-03-25
License: https://open.fda.gov/license/

Laax, Inc. / initiated 2015-03-25 / Terminated

FDA source

Laax, Inc. began a recall of 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... on 2015-03-25. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1462-2015
Classification: Class I
Status: Terminated
Initiated: 2015-03-25
Posted: 2015-04-23
Terminated: 2017-03-17
Recalling firm: Laax, Inc.
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).
Product code: GDW Staple, Implantable
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.
FDA 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:[email protected] 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).
Quantity in commerce: ~4,154 units distributed in US - both part 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.
Product codes and lots: Part number C-TP-1509 (9 connector) All serial numbers/lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1462-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1461-2015	Class I	Terminated	Voluntary: Firm initiated	2015-04-29	2015-04-23
Z-1462-2015	Class I	Terminated	Voluntary: Firm initiated	2015-04-29	2015-04-23

Product code GDW

K111064Class IITigerpaw System IILaax, Inc. / cleared 2011-05-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)