# FDA recall Z-1555-2020

> **Boston Scientific Corporation** · Class I · device recall initiated 2020-02-11.

## Product

Imager II 5F Angiographic Catheters, 5 units per package.

## Reason for recall

Potential for tip detachment of Imager II 5F Angiographic Catheters

## Distribution

Worldwide distribution.  US nationwide, Australia, Belgium, Brazil, Canada, Switzerland, China, Colombia, Cyprus, Czech Republic, Germany, Spain, Finland, France, Great Britain, Greece, Croatia, Hungary, Indonesia, Israel, India, Italy, Jordan, Japan, South Korea, Lebanon, Lithuania, Mexico, Malaysia, Netherlands, Norway, Poland, Russia, Sweden, Slovakia, Turkey, Taiwan, and South Africa.

## Key facts

- **Recall number:** Z-1555-2020
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-02-11
- **Report date:** 2020-04-01

- **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-1555-2020

## Citation

> AI Analytics. FDA recall Z-1555-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1555-2020. Source: US FDA. Licensed CC0.

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