Recall Z-3188-2026 ยท FGB Ureteroscope And Accessories, Flexible/Rigid
Boston Scientific Corporation
Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord, (1) Power Adaptor, (1)DVI Cable, (1) DVI to HDMI Cable, (1) DisplayPort Cable REF: M0067933000, M006793300H0, M006793300R0, M006793300D0, M006793300Z0, M0067930000, M006793000R0
| Date | Sep 16, 2026 (initiated Jul 22, 2026) |
| Status | Open, Classified |
| Reason | A subset of power adapters used with the connect console may exhibit higher-than-expected resistance in the electrical grounding path. As a result, the power adaptor may fail electrical safety testing during installation. |
| Root cause | Nonconforming Material/Component |
| Action | On July 22, 2026, Boston Scientific Corporation issued a medical device correction to affected consignees via FedEx letter, Boston Scientific Corporation requested consignees to take the following actions: 1. Continue to use the affected devices according to the Instructions for Use. 2. Forward this notice to relevant personnel and any facilities to which the impacted device was transferred. 3. Complete and return the enclosed Acknowledgement Form. 4. Begin using the replacement power adaptor upon receipt and dispose of the affected power adaptor in accordance with local requirements. |
| Quantity | 982 units |
| Distribution | Worldwide - US Nationwide distribution including in the states of AZ, FL, CA, OR, IL, NC, NE, UT, CO, OH, AR, NM, AL, WI, TN, IN, GA, OH, WI, KY, CT, KS, SC, IL, NE, MO, MS, DE, TX, NY, WV, MA, MT, WA, WY, NV, HI, ID, MO, ME, WV, NE, OK, MN, LA, WV, NV, PA, NH, NJ, MI, MO, AK, VA, MS, WY, ME and the |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K233645 | StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection Boston Scientific Corporation -, Dec 12, 2023 |