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.
This recall has been terminated (originally issued July 11, 2011).
- Company
- Edwards Lifesciences, Llc
- Recall Initiated
- June 15, 2011
- Posted
- July 11, 2011
- Terminated
- June 1, 2012
- Recall Number
- Z-2776-2011
- Quantity
- 2798 units
- Firm Location
- Draper, UT
- Official Source
- View on FDA website ↗
Reason for Recall
Possibility of separation of the introducer sheath from the hub on Coronary Sinus Catheters.
Distribution
Nationwide Distribution.
Lot / Code Info
Lot numbers: 751029B, 751036B, 751041B, 755814AB, 763115B, 763119B, 763123B, 763125B, 763127B, 763128B, 763129B, 774333B, 774334B, 774336B, 774337, 774337B, 784527B, 794302B, 794303, 794586, 798587, 818578, 818581, 821595, 831328, 833441, 841434, 848624, 848628, 848632, 856438, 856502, 856509, 856510, 856513.
Root Cause
Employee error
Action Taken
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.