Class 2 Device Recall Boston Scientific

• Date Initiated by Firm: March 03, 2022
• Create Date: May 13, 2022
• Recall Status: Open, Classified
• Recall Number: Z-1081-2022
• Recall Event ID: 89931
• 510(K)Number: K193202
• Product Classification: Duodenoscope and accessories, flexible/rigid - Product Code FDT
• Product: EXALT Model D Single-Use Duodenoscope (Box 1) UPN:M0054242CE0 Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perform various procedures within the duodenum including endoscopy and endoscopic surgery.
• Code Information: All lots GTIN: 08714729995746
• FEI Number: 3005099803
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 100 Boston Scientific Way; Marlborough MA 01752-1234
• For Additional Information Contact: Rebecca KinKead Rubio ; 508-683-4000
• Manufacturer Reason for Recall: Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement, and removal of this device.
• FDA Determined Cause: Device Design
• Action: Boston Scientific notified US and US Territories from March 3rd through March 17th, via hand delivery, FedEx, or e-mail . OUS Consignees were notified from March 3rd through March 10th, via hand delivery, courier, or e-mail. Additional US Consignees located in the US and US Territories were notified from April 7, 2022, through April 13, 2022. Additional OUS Consignees were notified on April 7, 2022. Immediate Action Required EXALT Model D Single-Use Duodenoscope. Letter states. Customers to whom hand-delivery is not possible within a ten-day timeframe will receive the letter through other means (e.g., courier, e-mail). The notification instructs the account to review the content of the IFU updates, share the information and post it in a visible location near the product, and to complete the Acknowledgment Form to confirm receipt of the notification. After all applicable regulatory approvals are obtained, the updated IFUs will be packaged with EXALT Model D Single-Use Duodenoscopes. An updated IFU will be available at https://www.bostonscientific.com/elabeling in the US. ***UPDATE 4/29/22: BSC implemented the updated IFU for US customers (an electronic-only IFU published to BSC's website) on March 21 , 2022. This electronic-only IFU supports UPNs M00542420 and M00542421 (the UPNs intended primarily for US distribution). BSC will implement the updated IFU for OUS customers (in UPNs M0054242CE0 and M0054242CE1 , the UPNs intended primarily for OUS distribution) following language translations and receipt of paper IFU inventory, estimated for May 2022.
• Quantity in Commerce: OUS: 1,094 units
• Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Bulgaria, Canada, China, Czech Republic, Denmark, Egypt, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, IRELAND, Israel, Italy, Kuwait, Netherlands, Norway, Oman, Poland, Portugal, Qatar, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Unit. Arab Emir.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FDT