Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites in the vasc
FDA device recall Z-2645-2017 · posted 2017-06-27 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- A field report indicated some units within this lot were missing the bottom pouch seal. The compromised seal is completely missing and is obvious to the user.
- Action taken
- Customers were sent an Urgent Medical Device Removal letter, dated 12/15/2016, via overnight mail delivery beginning 12/15/2016. The letter identified affected product, described the issue, and asked for product to be returned. Removal instructions were provided and a Reply Verification Tracking Form was asked to be returned. Questions can be directed to Nicole Pshon, Field Action Manager at 763-494-1133 or BSCFieldActionCenter@bsci.com
- Root cause
- Employee error
- Status
- Terminated
- Product code
- DQO
- Quantity affected
- 39 boxes of 5 (195 units)
- Distribution
- CA, FL, KY, MO, NM, OK, OR, PA, and TX.
- Date initiated
- 2016-12-15
- Date posted
- 2017-06-27
- Date terminated
- 2018-04-10
- Location
- Maple Grove, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IMAGER II ANGIOGRAPHIC CATHETER (K121694) | Boston Scientific Corp | 2012-09-14 |