[Recalled] 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) — A field rep
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| 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) |
|---|---|
| Brand / manufacturer | Boston Scientific Corporation |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2645-2017 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 15 December 2016 |
| EAN / barcode | 00112758 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
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This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.