# FDA recall Z-1160-2026

> **Boston Scientific Corporation** · Class I · device recall initiated 2025-12-19.

## Product

AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm;  Material Number (UPN): M00553690;

## Reason for recall

Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one.  The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or  expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.

## Distribution

Worldwide distribution. US Nationwide including Puerto Rico;  Algeria, Argentina, Austria, Belgium, Brazil, Canada, CHILE, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, JAPAN, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Oman, Pakistan, Palestine, Panama, Paraguay, PERU, Poland, Portugal, Romania, Saudi Arabia, Serbia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, UAE, and United Kingdom.

## Key facts

- **Recall number:** Z-1160-2026
- **Recalling firm:** Boston Scientific Corporation
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-12-19
- **Report date:** 2026-02-11

- **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-1160-2026

## Citation

> AI Analytics. FDA recall Z-1160-2026. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-1160-2026. Source: US FDA. Licensed CC0.

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