FDA Issues Class I Recall for Tiger Paw System II for Tears and Bleeding in Heart Tissue
Written By: Rheingold, Valet, Rheingold, Ruffo & Giuffra LLP
FDA announced a Class I Recall of the Tiger Paw System II, produced by Maquet Medical Systems. The Class I is the most serious FDA Recall issued when there is a reasonable probability that the use of a product will cause serious adverse health consequences or death. The TigerPaw II is a surgical staple device used to close tissue in the left atrial appendage (LAA) of the heart, used during open heart surgery.
The staple faces issues of incomplete closure which can result in tissue tears and/or bleeding, including a possible tear on the left atrial wall during use of the device. Maquet Medical Systems received 51 reports of adverse events and one death.
The device has been distributed since April 1, 2013 through March 23, 2015, after which Maquet Medical sent an "Urgent Medical Device Recall (Removal) Immediate Action Required" letter to all affected customers. Patients are instructed to examine their inventory for any TigerPaw System II recalled devices and remove and quarantine any such devices.
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
- Call 1-800-332-1088 to request a reporting form, complete and return by mail or by fax to 1-800-FDA-0178