—#96454

Product

EndoPlege Sinus Catheter Kit, REF EP, 9 Fr x 18.9", Contains Phthalates, Sterile EO, Sterile R, Edwards Lifesciences LLC, Irvine, CA 92614. The EndoPlege coronary sinus catheter 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 EndoPlege coronary sinus catheter contamination guard, is packaged with these catheters

FDA product code: DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K964248
Affected lot / code info: Lot No.: 718993, 718995, 718996, 718998, 718999, 719000, 719001, 739692, 739693, 742834, 742835, 747591, 751029, 751036, 751041, 755814, 755814A, 763115, 763119, 763123, 763125, 763127, 763128, 763129, 774333, 774334.

Why it was recalled

Defective product may result in the silicone valve becoming dislodged from the introducer which can result in injury.

Root cause (FDA determination)

Device Design

Action the firm took

The firm, Edwards Lifesciences, sent an "URGENT PRODUCT RECALL - ACTION REQUIRED" letter dated December 3, 2010 to customers. The letter describes the product, problem and actions to be taken by the customers. The customers were instructed to check their inventory and return the unused devices; complete and return the INTROCSC Introducer Recall Response form to the attention of Customer Service, Edwards LifeSciences, One Edwards Way, Irvine, CA at 949-250-3489. If you have any questions, please contact Edwards Customer Service at 800-424-3278 from 8:00am - 4:30pm Pacific Time.

Recalling firm

Firm: Edwards Lifesciences Llc
Address: 12050 Lone Peak Parkway, Draper, Utah 84020-9414

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2010-12-03
Posted by FDA: 2011-01-28
Terminated: 2011-10-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #96454. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.