SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600
Reported: March 28, 2018 Initiated: December 20, 2017 #Z-1133-2018
Product Description
SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600
Reason for Recall
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.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 5026
- Distribution
- 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
- Location
- Marlborough, MA
Frequently Asked Questions
What product was recalled? ▼
SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600. Recalled by Boston Scientific Corporation. Units affected: 5026.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 28, 2018. Severity: Moderate. Recall number: Z-1133-2018.
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