—#107941

Product

Boston Scientific Soloist Single Needle Electrode: 18 cm long, 16 gauge, Sterile, packaged with the Soloist Electrode Power Cord. Boston Scientific, Nalick, MA. The Soloist Needle Electrode is intended for use in conjunction with a Boston Scientific Corporation radiofrequency. (RF) generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.

FDA product code: GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K053128
Affected lot / code info: Soloist Single Needle M001262500 Reference Inner 14386589, 14435130, 14578709, 14629530, 14715963, Electrode -18cm (outer pouch Information) 14722621, 14776399, 14805361 box)

Why it was recalled

Device found labeled with the incorrect expiration dates. The Soloist Single Needle Electrode has been qualified for a 3 year expiration date. Product manufactured between the dates of May 24, 2011 and November 8, 2011 has an incorrect expiration date of 20 years labeled on the pouched needle electrode and 5 years labeled on the carton.

Root cause (FDA determination)

Incorrect or no expiration date

Action the firm took

Boston Scientific sent a Urgent Medical Device Recall letter dated March 2, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter instructed to cease use, quarantine and return unused product with directions to forward the notification to the hospital level. Customers were directed to fill out the Reply Verification Tracking Form and fax to 5086835578, for reimbursement. Returned goods are to be sent to: Boston Scientific Corporation Distribution Center Attn: QA Returns 500 Commander Shea Blvd Quincy, MA 02171 We regret any inconvenience that this action may cause and we appreciate your understanding as we take action to ensure patient safety and customer satisfaction. For further questions please call (508) 683-4678.

Recalling firm

Firm: Boston Scientific Corporation
Address: 100 Boston Scientific Way, Marlborough, Massachusetts 01752-1234

Distribution

Distribution pattern: USA (nationwide) and the countries of Canada, Columbia, Viet Nam, Germany, France, Great Britain, Italy, Jordan, Kuwait, Netherlands Pakistan, Portugal, S. Arabia, Slovakia, Spain, Sweden and Tunisia.

Timeline

Recall initiated: 2012-03-02
Posted by FDA: 2012-03-28
Terminated: 2012-11-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #107941. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.