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Terminated

SpyScope DS Access and Delivery diagnostic biliary catheter, M00546600

FDA Recall Z-1133-2018 · Posted None

Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeFBN
Date Initiated2017-12-20
Date Terminated2019-12-13
Product Quantity5026

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.

Firm Action

The notification letter requests the consignee to identify and return the affected product along with the response form. Distributors are asked to share the recall information to the customer level. 12/20/2017 by mail.

Root Cause

Process design

Distribution Pattern

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

Official Source

View FDA Recall →

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

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