FDA Recall Terminated

Endopledge Sinus Catheter Kit, REF: EP, 9 Fr x 18.9", Sterile EO, Sterile R, Edwards Lifesciences LLC, Irvine, CA. Device is a three-lumen, 9 Fr catheter with an elastomeric balloon near its tip for occluding the coronary sinus in order to retrograde perfuse the coronary circulation. An 11 Fr catheter introducer sheath, which is compatible with the catheter contamination guard, is packaged with these catheters.

Recall: Z-2776-2011 · Initiated June 15, 2011

Recall

Recall Number: Z-2776-2011
Event Number: 59135
Firm: Edwards Lifesciences, LLC
FEI Number: 1713910
Product Code: DWF
Status: Terminated
Root Cause: Employee error
Initiated: June 15, 2011
Posted: July 11, 2011
Terminated: June 1, 2012
Address: 12050 Lone Peak Pkwy, Draper, UT, 84020-9414

Description

Reason

Possibility of separation of the introducer sheath from the hub on Coronary Sinus Catheters.

Action

Edwards Lifesciences, LLC sent an Urgent Product Recall - Action Required letter dated June 15, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Cusotmers were instructed to check their inventory for any affected product and return all unused product from their stock to Edwards at: Edwards Lifesciences 12060 Lone Peak Pkwy Draper, UT 84020 Attention: Suzanne Carpenter, RGA # Customers were instructed to contact Customer Service to obtain a Returned Goods Authorization number and replacement product . Once customers verified their inventory, they were to complete the attached form and fax it to Edwards at (949) 250-3489. For any questions customers were instructed to call Edwards Customer Service at (800) 424-3278.

Distribution

Nationwide Distribution.

Quantity

2798 units