FDA-Device2018-03-28Class II
SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600
Hazard
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.
Sold states
Worldwide Distribution US nationwide, Austria, Belarus, Belguim, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Hungary, Ireland, Israel, Italy, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Spain, Sweden, Switzerland, Bahrain, China, Hong Kong, India, Malaysia, Pakistan, Qatar, Saudi Arabia, Singapore, South Africa, South Korea, Thailand, Tunisia, Turkey, Vietnam, Brazil, Canada, Cost Rica, Ecuador, Guatemala, Mexico, Peru
Affected count
5026
Manufactured in
100 Boston Scientific Way, N/A, Marlborough, MA, United States
Products
SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1133-2018More Boston Scientific Corporation recalls
- FDA-Device2026-07-29Boston Scientific FARADRIVE steerable sheath recalled for air embolism risk from valve damage
- FDA-Device2026-07-29Boston Scientific FARASTAR PFA Generator recalled for catheter incompatibility
- FDA-Device2026-07-29Boston Scientific FARASTAR Ablation Generator recalled for incomplete instructions
- FDA-Device2026-07-29Boston Scientific FARASTAR PFA Generator recalled for incomplete instructions
- FDA-Device2026-07-29Boston Scientific FARASTAR PFA Generator recalled for incomplete labeling
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