EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0.
FDA device recall Z-0396-2024 · posted 2023-11-21 · Open, Classified
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Poor image quality due to fluid ingress in the lens.
- Action taken
- 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 Scientific has implemented corrective changes and will make replacement EXALT Model D scopes available as soon as possible.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- FDT
- Quantity affected
- 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
- Date initiated
- 2023-09-27
- Date posted
- 2023-11-21
- Location
- Marlborough, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXALT Model D Single-Use Duodenoscope, EXALT Controller (K193202) | Boston Scientific Corporation | 2019-12-13 |