Boston Scientific Recalls SpyScope DS Biliary Catheters Due to Sleeve Defect
Boston Scientific is recalling 5,026 units of SpyScope DS Access and Delivery diagnostic biliary catheters because a sleeve may protrude, causing tissue damage or bleeding.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of significant bleeding, which aligns with the rubric criteria for Severe severity involving significant injury reports or high-risk medical device defects.
Plain-English summary
Boston Scientific Corporation is recalling 5,026 units of the SpyScope DS Access and Delivery diagnostic biliary catheter (catalog number M00546600). The recall was initiated because certain lots of the device may have the working channel sleeve protruding from the camera cap.
This defect may result in injuries ranging from minor tissue damage to significant bleeding. The affected devices were distributed worldwide, including in the United States and numerous international locations such as Canada, Mexico, and various countries in Europe, Asia, and the Middle East.
Healthcare providers and consumers should stop using the affected devices immediately. Boston Scientific is the recalling firm responsible for managing this Class II recall.
The recalled product
- Product
- SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 5,026
Distribution
Distributed nationwide across the United States.
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