Recall Z-0396-2024 ยท FDT Duodenoscope And Accessories, Flexible/Rigid
Boston Scientific Corporation
EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0.
| Date | Nov 21, 2023 (initiated Sep 27, 2023) |
| Status | Open, Classified |
| Reason | Poor image quality due to fluid ingress in the lens. |
| Root cause | Process control |
| Action | Notification of Urgent Medical Device Product Removal was issued via FedEx on Oct 3, 2023. The notice advises customers to immediately discontinue use and segregate affected product, and to complete and return the Reply Verification and Tracking Form (RVTF) even if you do not have any affected product. Customers are to post the notice near any affected product and notify end users. If further distributed, notify any customers to which product has been further distributed to. Reach out to your local Boston Scientific representative with any questions. The notice is batch / lot specific. Boston |
| Quantity | US: 586 devices & OUS: 81 devices |
| Distribution | Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA VT, WA, WI & WV. The countries of Australia, Belgium, C |
| 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 |