FDA Device recall Z-2645-2017
Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites in the vascular system
- FDA Device
- Class II
- terminated
- Published 2017-07-12
On 2017-07-12 the FDA classified a Class II recall of Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites in the vascular system by Boston Scientific, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2645-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-12-15 |
| Published | 2017-07-12 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Boston Scientific |
| Distribution | CA, FL, KY, MO, NM, OK, OR, PA, TX |
Product
Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites in the vascular system. M001314141 (5-pack outer package UPN), M001314140, single unit, inner package UPN)
Reason
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.
Identifiers
| code_info | Lot: 00112758, Use by 2018-05-11 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2645-2017%22
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