—#118604

Product

RigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00554510 Product Usage: The Boston Scientific Corporation RigiflexTM II Single- Use Achalasia Balloon Dilator is indicated for dilatation of the cardia in patients with achalasia.

FDA product code: KNQ — Dilator, Esophageal
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K050232
Affected lot / code info: Lot/Batch Number: 091541

Why it was recalled

Product labeled with incorrect expiration date.

Root cause (FDA determination)

Incorrect or no expiration date

Action the firm took

Boston Scientific sent an Urgent: Medical Device Recall letter to all affected customers via Federal Express. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to immediately discontinue use, check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The letter also requests the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product from their inventory. Follow-up communications will be made to the accounts that do not respond. For questions contact your local Sales Representative.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - USA Nationwide including the state of NY, NE, MD, OH, TX, PA, VA, PR, CA, NJ, NY, CA and the countries of: AT, FR, DE, GB, IL, IT, LB, NL, ES, SE, TN, Argentina, and Japan.

Timeline

Recall initiated: 2013-05-28
Posted by FDA: 2013-07-10
Terminated: 2014-02-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #118604. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.