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Open, Classified

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

FDA Recall Z-3188-2026 · Posted 2026-09-16

Recalling FirmBoston Scientific Corporation
Recall StatusOpen, Classified
Product CodeFGB
Date Initiated2026-07-22
Product Quantity982 units

Reason for Recall

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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 countries of Australia, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Lebanon, Norway, Poland, Portugal, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Turkiye, Canada, Hong Kong, Singapore, Taiwan, Argentina, Chile, Japan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K233645StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse DeflectionBoston Scientific Corporation - · 2023-12-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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