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Open, Classified

Imager II 5F Angiographic Catheters, 5 units per package.

FDA Recall Z-1555-2020 · Posted 2020-03-25

Recalling FirmBoston Scientific Corporation
Recall StatusOpen, Classified
Product CodeDQO
Date Initiated2020-02-11
Product Quantity1068827 Single Units

Reason for Recall

Potential for tip detachment of Imager II 5F Angiographic Catheters

Firm Action

Boston Scientific notified customers on about 02/11/2020 via "Urgent Medical Device Removal" letter. Customers were informed that Boston Scientific has noticed an increase in the rate of tip detachment complaints involving the recalled devices. Instructions included to examine inventory and quarantine affected products, complete and return the Verification Form, return all affected devices to Boston Scientific, and notify customers if affected devices were further distributed. An expansion letter was dated 08/06/2020 to include all batches/lots of the BSC Imager II Angiographic Catheter - 5 French Curved Tip Shapes.

Root Cause

Environmental control

Distribution Pattern

Worldwide distribution. US nationwide, Australia, Belgium, Brazil, Canada, Switzerland, China, Colombia, Cyprus, Czech Republic, Germany, Spain, Finland, France, Great Britain, Greece, Croatia, Hungary, Indonesia, Israel, India, Italy, Jordan, Japan, South Korea, Lebanon, Lithuania, Mexico, Malaysia, Netherlands, Norway, Poland, Russia, Sweden, Slovakia, Turkey, Taiwan, and South Africa.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K121694IMAGER II ANGIOGRAPHIC CATHETERBoston Scientific Corp · 2012-09-14

Official Source

View FDA Recall →

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

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