Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

SpyScope DS Access and Delivery diagnostic biliary catheter Recalled by Boston Scientific Corporation Due to Certain lots of devices may have the working...

Date: December 20, 2017
Company: Boston Scientific Corporation
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Boston Scientific Corporation directly.

Affected Products

SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600

Quantity: 5026

Why Was This Recalled?

Certain lots of devices may have the working channel sleeve protruding from the camera cap which may result in injuries from minor tissue damage to significant bleeding.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Boston Scientific Corporation

Boston Scientific Corporation has 601 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report