# FDA recall Z-1079-2022

> **Boston Scientific Corporation** · Class II · device recall initiated 2022-03-03.

## Product

EXALT Model D Single- Use Duodenoscope (Box 1)  UPN:  M00542420     Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perform various procedures within the duodenum including endoscopy and endoscopic surgery.

## Reason for recall

Updated Instructions for Use (IFU) for EXALT Model D  Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement, and removal of this device.

## Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium,  Bulgaria, Canada, China, Czech Republic, Denmark, Egypt, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, IRELAND, Israel, Italy, Kuwait, Netherlands,  Norway, Oman, Poland, Portugal, Qatar, Saudi Arabia, Slovakia, South Africa, Spain,  Sweden, Switzerland, Taiwan, Unit. Arab Emir.

## Key facts

- **Recall number:** Z-1079-2022
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-03-03
- **Report date:** 2022-05-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Marlborough, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1079-2022

## Citation

> AI Analytics. FDA recall Z-1079-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1079-2022. Source: US FDA. Licensed CC0.

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