Imager II 5F Angiographic Catheters, 5 units per package.
FDA device recall Z-1555-2020 · posted 2020-03-25 · Open, Classified
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Potential for tip detachment of Imager II 5F Angiographic Catheters
- Action taken
- 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
- Status
- Open, Classified
- Product code
- DQO
- Quantity affected
- 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, Hungar
- Date initiated
- 2020-02-11
- Date posted
- 2020-03-25
- Location
- Maple Grove, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IMAGER II ANGIOGRAPHIC CATHETER (K121694) | Boston Scientific Corp | 2012-09-14 |