—#210762

Product

AMS Artificial Urinary Sphincter Control Pump

FDA product code: EZY — Device, Incontinence, Mechanical/Hydraulic
Device class: Class 3
Medical specialty: Gastroenterology, Urology
PMA numbers: P000053
Affected lot / code info: UPN Number: 72400098. GTIN Number: 00878953000688. Lot Number: 32487464. Serial Numbers: 1100366307, 1100366316, 1100366309, 1100366317, 1100366310, 1100366319, 1100366311, 1100366320, 1100366312, 1100366321, 1100366313, 1100366323, 1100366314, 1100366324, 1100366315, 1100366325. Expiration Date: 09/24/2028

Why it was recalled

Potential for mislabeled packaging in which a device labeled as a Pressure Regulating Balloon (UPN 72400024) which instead contained a Control Pump (UPN 72400098)

Root cause (FDA determination)

Error in labeling

Action the firm took

Boston Scientific notified their consignees on about 10/28/2024 via letter. Consignees were instructed to immediately discontinue use and segregate the affected products, notify all personnel that need to be aware, notify customers if further distributed, arrange for the return of affected product and complete and return the Reply Verification Tracking Form (RVtF).

Recalling firm

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

Distribution

Distribution pattern: Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, KS, LA, MA, MI, MN, NY, OR, PA, TX, VA, WA and the countries of Argentina, Australia, Austria, Belgium, Chile, China, Costa Rica, Czech Republic, Finland, France, Germany, Ireland, Netherlands, Poland, Puerto Rico, South Korea, Spain, Sweden, Switzerland, and Taiwan.

Timeline

Recall initiated: 2024-10-28
Posted by FDA: 2024-11-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #210762. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.