Recall Z-1555-2020 ยท DQO Catheter, Intravascular, Diagnostic
Boston Scientific Corporation
Imager II 5F Angiographic Catheters, 5 units per package.
| Date | Mar 25, 2020 (initiated Feb 11, 2020) |
| Status | Open, Classified |
| Reason | Potential for tip detachment of Imager II 5F Angiographic Catheters |
| Root cause | Environmental control |
| 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 - |
| Quantity | 1068827 Single Units |
| Distribution | 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, Malaysi |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121694 | IMAGER II ANGIOGRAPHIC CATHETER Boston Scientific Corp, Sep 14, 2012 |