Steerable Coronary Sinus Catheter Kit, REF SCS01, 9 Fr x 20.4", Contains Phthalates, Sterile EO, Edwards Lifesciences LLC, Irvine, CA 92614. The Steerable 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 Steerable Coronary Sinus Catheter contamination guard, is packaged with these catheters.
This recall has been terminated (originally issued January 28, 2011).
- Company
- Edwards Lifesciences, Llc
- Recall Initiated
- December 3, 2010
- Posted
- January 28, 2011
- Terminated
- October 27, 2011
- Recall Number
- Z-0992-2011
- Quantity
- 90 kits
- Firm Location
- Draper, UT
- Official Source
- View on FDA website ↗
Reason for Recall
Defective product may result in the silicone valve becoming dislodged from the introducer which can result in injury.
Distribution
Nationwide Distribution
Lot / Code Info
Lot No.: 666556, 669235, 678238, 751043, 755821, 763122
Root Cause
Device Design
Action Taken
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.