[Posted 05/07/2015]
AUDIENCE: Cardiology, Risk Manager
ISSUE: FDA announced a Class I Recall of all lots of the Tiger Paw System II by Maquet Medical Systems. Incomplete closure of the TigerPaw System II may result in tissue tears and/or bleeding, including a possible tear on the left atrial wall (top left chamber) during use of the device. Maquet Medical Systems received 51 reports of adverse events and one death.
BACKGROUND: The TigerPaw II is a surgical staple used to close tissue in the left atrial appendage (LAA) of the heart.
The affected devices were distributed April 1, 2013 through March 23, 2015.
Maquet Medical Systems, on behalf of Laax, Inc., sent an “Urgent Medical Device Recall (Removal) Immediate Action Required” letter, dated March 30, 2015, to all affected customers.
RECOMMENDATION: Customers are instructed to:
- Immediately examine inventory for any TigerPaw System II recalled devices.
- Remove, quarantine, and place recalled devices in a secure location.
- Complete and return the Medical Device Recall (Removal) Response Form by emailing a scanned copy to TigerPaw2015@maquet.com or FAX to 1-(973)-396-3607.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[05/07/2015 - Recall Notice - FDA]
