Recall Z-1079-2022 ยท FDT Duodenoscope And Accessories, Flexible/Rigid
Boston Scientific Corporation
EXALT Model D Single- Use Duodenoscope (Box 1) UPN: M00542420 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.
| Date | Mar 3, 2022 |
| Status | Open, Classified |
| Reason | 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. |
| Root 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 |
| Quantity | 1486 units: US: 1,441; OUS: 45 |
| 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, S |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193202 | EXALT Model D Single-Use Duodenoscope, EXALT Controller Boston Scientific Corporation, Dec 13, 2019 |