Class 2 Device Recall AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff

• Date Initiated by Firm: July 19, 2019
• Create Date: August 30, 2019
• Recall Status: Terminated on April 23, 2020
• Recall Number: Z-2442-2019
• Recall Event ID: 83567
• PMA Number: P000053
• Product Classification: Device, incontinence, mechanical/hydraulic - Product Code EZY
• Product: AMS 800 Artificial Urinary Sphincter AMS 800 Belt Cuff, 4.5 cm Part Number: 72400161
• Code Information: Lot Number: 23973023
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 300 Boston Scientific Way; Marlborough MA 01752-1291
• For Additional Information Contact: Nicole Pshon; 763-494-1133
• Manufacturer Reason for Recall: Mislabled: AMS 800 occlusive cuff labeled as 4.5 cm was a length of 4.0 cm and therefore..
• FDA Determined Cause: Error in labeling
• Action: Boston Scientific contacted customer via the sales representative on July 19, 2019. The removal letter was given to the customer by the sales representative. The letter states reason for recall, health risk and Immediately segregate the affected product to ensure that it will not be used. 2. Contact the Boston Scientific Field Action center for an RGA number to facilitate product return. 3. Ship product back to Boston Scientific
• Quantity in Commerce: 1 unit
• Distribution: MN
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = EZY