Recalls / —
—#203827
Product
EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0.
- FDA product code
- FDT — Duodenoscope And Accessories, Flexible/Rigid
- Device class
- Class 2
- Medical specialty
- Gastroenterology, Urology
- 510(k) numbers
- K193202
- Affected lot / code info
- UDI-DI (GTIN): 08714729983514, Outer box UPN# M00542420, Lot / Batch # 31137538, 31537335, 31228699, 31590604, 31257049, 31635405, 31257050, 31683854, 31258726, 31802917, 31329914, 31810037, 31398618, 31991955, 31438355, 32006891, 31473069, 32146684. UDI-DI (GTIN): 08714729995746, Outer box UPN# M0054242CE0, Lot / Batch # 31199348, 31712358, 31574944.
Why it was recalled
Poor image quality due to fluid ingress in the lens.
Root cause (FDA determination)
Process control
Action the firm took
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.
Recalling firm
- Firm
- Boston Scientific Corporation
- Address
- 100 Boston Scientific Way, Marlborough, Massachusetts 01752-1234
Distribution
- Distribution pattern
- 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, Canada, Czech Republic, Denmark, France, Germany, Great Britain, Italy, New Zealand, Spain, Sweden, Switzerland.
Timeline
- Recall initiated
- 2023-09-27
- Posted by FDA
- 2023-11-21
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #203827. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.