Boston Scientific Imager II Angiographic Catheter — Class II medical device recall Z-1781-2017
Terminated recall by Boston Scientific Corporation, reported 2017-04-19, distributed in AZ, FL, MO, NJ, NY, OH, PA, TX. One lot of Imager II Angiographic Catheters is being recalled due to packaging mislabeling. The product may be
| Recall number | Z-1781-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Maple Grove, MN, United States |
| Recall initiated | 2016-12-13 |
| Classified | 2017-04-11 |
| Reported by FDA | 2017-04-19 |
| Terminated | 2017-11-22 |
| Distributed | AZ, FL, MO, NJ, NY, OH, PA, TX |
| Reason classes | labeling |
| Lot numbers | 00116127 |
| Expiration dates | 2018-09-30 |
Product
Boston Scientific Imager II Angiographic Catheter, M001316581 (5-pack outer package UPN), M001316580, single unit, inner package UPN)
Reason for recall
One lot of Imager II Angiographic Catheters is being recalled due to packaging mislabeling. The product may be labeled as Imager II Contra 2 curve catheters, when in fact the package contains Contra curve catheters.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1781-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.