—#94904

Product

Boston Scientific Peristaltic Tubing Kit, Model 2104, UPN M0043521040. For use with Boston Scientific CHILLI Cooled Ablation Catheters and Model 8005 Continuous Operation Pump. Sterilized using Ethylene Oxide. Contents: peristaltic pump fluid delivery extension tube set. Manufactured for: Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, USA. Tubing Set (model 2104) for use with Boston Scientific Cooled Ablation System.

FDA product code: LPB — Cardiac Ablation Percutaneous Catheter
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P980003, P990054
Affected lot / code info: Lot: 61035169, 61071543, 61066975, 61066976, 61088879, 61088880, 61088881, 61088882, 61090636

Why it was recalled

Boston Scientific is conducting a Recall on CircuCool Tubing Sets used with the Chilli II Cooled Ablation System because there may be a potential for a sterile barrier breach which could compromise device sterility and potentially the sterile field. Even though there have been no reported complaints.

Root cause (FDA determination)

Packaging

Action the firm took

Boston Scientific Corporation sent an Urgent Medical Device Recall letter, dated September 27, 2010, to all customers via overnight Federal Express. The letter described the product, the problem, and the action the customer should take. The letter instructed customers to cease distribution of affected devices and remove them from their inventory, segregate in a secure location for return to Boston Scientific. A Reply Verification Tracking Form was to be completed and returned via email or faxed to (510) 624-2475 even if the customer did not have any of the affected product. If affected units were located the customer was to call (510) 624-2563 to obtain a Returned Good Authorization (RGA) Number and return to: Boston Scientific Corporation US Distribution Center Boston Scientific Marina Bay Customer Fulfillment Center 500 Commander Shea Blvd. Quincy, Massachusetts 02171 RGA: _________________ For additional questions call (510) 624-2563.

Recalling firm

Firm: Boston Scientific Corporation
Address: 1 Scimed Pl, Maple Grove, Minnesota 55311-1565

Distribution

Distribution pattern: Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NM, NY, OH, PA, RI, SC, TN, TX, VA, WA, and WV and the countries of France, Germany, Great Britain, Hungary, Israel, Italy, Netherlands, Saudi Arabia, Spain, and Taiwan

Timeline

Recall initiated: 2010-09-27
Posted by FDA: 2010-11-01
Terminated: 2012-04-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #94904. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.