# FDA recall Z-0776-2021

> **Boston Scientific Corporation** · Class II · device recall initiated 2020-12-01.

## Product

Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm (OUS) UPN: M00553540 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.

## Reason for recall

The rotating luer fitting at the distal end of the  delivery system handle may become detached from the nose of the delivery  during device preparation, stent delivery or use, resulting in delay or procedure or  risk of peritonitis developing from leakage of enteric, pseudocyst, or biliary contents into the peritoneal cavity

## Distribution

US Nationwide distribution - Foreign: TBD.

## Key facts

- **Recall number:** Z-0776-2021
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-12-01
- **Report date:** 2021-01-13
- **Termination date:** 2023-07-14

- **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-0776-2021

## Citation

> AI Analytics. FDA recall Z-0776-2021. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-0776-2021. Source: US FDA. Licensed CC0.

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