# FDA recall Z-2645-2017

> **Boston Scientific Corporation** · Class II · device recall initiated 2016-12-15.

## 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 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.

## Distribution

CA, FL, KY, MO, NM, OK, OR, PA, and TX.

## Key facts

- **Recall number:** Z-2645-2017
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2016-12-15
- **Report date:** 2017-07-12
- **Termination date:** 2018-04-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Maple Grove, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2645-2017

## Citation

> AI Analytics. FDA recall Z-2645-2017. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-2645-2017. Source: US FDA. Licensed CC0.

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