# FDA recall Z-1374-2024

> **Boston Scientific Corporation** · Class I · device recall initiated 2024-02-20.

## Product

Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010

## Reason for recall

An investigation determined that delivery of the Obsidio embolic using the aliquot technique for lower gastrointestinal bleeding embolization poses a high risk of bowel ischemia. The most serious and the most common adverse health consequence, reasonably  foreseeable to occur, is the need to perform major surgery such as bowel resection and/or diverting colostomy. Therefore, Boston Scientific does not recommend that the aliquot technique be used to deliver the Obsidio device for lower GI bleed embolization procedures.

## Distribution

US

## Key facts

- **Recall number:** Z-1374-2024
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-02-20
- **Report date:** 2024-04-03

- **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-1374-2024

## Citation

> AI Analytics. FDA recall Z-1374-2024. Retrieved 2026-07-01 from https://api.ai-analytics.org/recall/Z-1374-2024. Source: US FDA. Licensed CC0.

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