EXALT Model D Single-Use Duodenoscope, 2 pack: Outer box UPN# M00542421, Inner box UPN # M00542420 & Outer box UPN# M0054242CE1, Inner box UPN # M0054242CE0.
Reported: November 29, 2023 Initiated: September 27, 2023 #Z-0397-2024
Product Description
EXALT Model D Single-Use Duodenoscope, 2 pack: Outer box UPN# M00542421, Inner box UPN # M00542420 & Outer box UPN# M0054242CE1, Inner box UPN # M0054242CE0.
Reason for Recall
Poor image quality due to fluid ingress in the lens.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- US: 5,709 devices & OUS: 180 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, Canada, Czech Republic, Denmark, France, Germany, Great Britain, Italy, New Zealand, Spain, Sweden, Switzerland.
- Location
- Marlborough, MA
Frequently Asked Questions
What product was recalled? ▼
EXALT Model D Single-Use Duodenoscope, 2 pack: Outer box UPN# M00542421, Inner box UPN # M00542420 & Outer box UPN# M0054242CE1, Inner box UPN # M0054242CE0.. Recalled by Boston Scientific Corporation. Units affected: US: 5,709 devices & OUS: 180 devices.
Why was this product recalled? ▼
Poor image quality due to fluid ingress in the lens.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 29, 2023. Severity: Moderate. Recall number: Z-0397-2024.
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