Use caution Medical device recall · FDA · Published December 1, 2020

Boston Scientific Hot AXIOS Stent Delivery System Recall: Risk of Peritonitis

Boston Scientific recalls Hot AXIOS Stent and Electrocautery Enhanced Delivery System 20mm x10mm (OUS) due to risk of peritonitis from leakage during procedures. Affected units have specific lot numbers and expiration dates.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0778-2021Medical device Boston Scientific ›

Use caution until it’s fixed

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

Take action

Contact the company

Recalling firmBoston Scientific Corporation300 Boston Scientific Way · Marlborough, MA 01752-1291

✎ GovInfoNow plain-language explainer

Boston Scientific is recalling a specific stent delivery system that could detach during use, potentially causing peritonitis. This risk occurs if the device leaks internal body fluids into the abdominal cavity during medical procedures. Read more at govinfonow.com/recall/63753-boston-scientific-hot-axios-stent-delivery-system-recall-risk-of.

Source Summary by GovInfoNow · govinfonow.com/recall/63753-boston-scientific-hot-axios-stent-delivery-system-recall-risk-of · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0778-2021

Cite this page

“Boston Scientific Hot AXIOS Stent Delivery System Recall: Risk of Peritonitis.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63753-boston-scientific-hot-axios-stent-delivery-system-recall-risk-of. Based on FDA recall #Z-0778-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0778-2021%22&limit=1).

The FDA announced on Dec. 1, 2020, that Boston Scientific Corporation voluntarily recalled the Hot AXIOS Stent and Electrocautery - Enhanced Delivery System due to a potential detachment of the rotating luer fitting. The agency classified the recall as Class II.

How to tell if you have it

Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm (OUS)
UPN: M00553560
UPC: 08714729951100
Lot Numbers: 26167277, 26171099, 26152171, 26171383, 26171380, 26152172
Expiration Dates: 10/8/2021, 10/12/2021

The hazard

According to the FDA, the rotating luer fitting at the distal end of the delivery system handle may become detached from the nose during device preparation or use. This detachment could result in a delay in procedure or risk of peritonitis developing from leakage of enteric, pseudocyst, or biliary contents into the peritoneal cavity.

Context

GovInfoNow's records show Boston Scientific Corporation has 124 other recalls on record since June 1, 2017. Recent recalls include the Imager II Angiographic Catheters Recall (Aug. 24, 2026) and the LUX-Dx Cardiac Monitor System Recall (Aug. 6, 2026). Other recent recalls of similar products include the Intracept Access Instruments Recall (April 22, 2026), the American Contract Systems Medical Kits Recall (May 19, 2026), and the Medtronic Perfusion Systems EOPA Cannula Recall (June 24, 2026).

How to tell if you have this one

Check for lot numbers: 26167277, 26171099, 26152171, 26171383, 26171380, 26152172. The product expires between October 8 and October 12, 2021.

Brand
Boston Scientific
Product
Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm (OUS) UPN: M00553560
Category
Medical device

FDA recall event · 6 products

All 6 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
US Nationwide distribution - Foreign: TBD.

Recall number	Product, codes & lots	Quantity
Z-0773-2021	AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm UPN: M00553640 - 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.; Lot Number: 26134666 Exp. Date: 10/6/2022 GTIN:08714729904588	13 units
Z-0774-2021	AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm UPN: M00553650 - 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.; Lot Number: 26152465, 26152466, 26152467 Exp. Date: 10/8/2022 GTIN: 08714729904595	32 units
Z-0775-2021	AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm UPN: M00553660 - 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.; Lot Number: 26167271, 26152176,26167274 Exp. Date Range: 10/8/2021 10/12/2021 GTIN: 08714729951179	38 units
Z-0776-2021	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.; Lot Number: 26130517 Exp. Date Range: 10/5/2022 GTIN: 08714729904564	8 units
Z-0777-2021	Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm (OUS) UPN: M00553550 - 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.; Lot Number: 26156059, 26167275, 26167276, 26156742, 26156740 Exp Date: 10/9/2022 10/12/2022 GTIN: 08714729904571	61 units
Z-0778-2021	Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm (OUS) UPN: M00553560 - 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.; Lot Number: 26167277, 26171099, 26152171, 26171383, 26171380, 26152172 Exp. Date Range: 10/8/2021 10/12/2021 GTIN: 08714729951100	78 units

Based on the official FDA remedy

What to do — step by step

Check Product Lot Number
Look for lot numbers 26167277, 26171099, 26152171, 26171383, 26171380, or 26152172 on the device packaging.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “US Nationwide distribution - Foreign: TBD.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 2.6 years after the firm started it.

Dec 1, 2020Firm started the recall
Jan 6, 2021FDA classified it Class II
Jan 13, 2021Published in FDA’s Enforcement Report
Jul 14, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to stop using this device immediately?

The recall does not require immediate stop use; however, if you have the recalled lot numbers, you should check with your healthcare provider about the risks.

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Link to this recall

<a href="https://govinfonow.com/recall/63753-boston-scientific-hot-axios-stent-delivery-system-recall-risk-of">Boston Scientific Hot AXIOS Stent Delivery System Recall: Risk of Peritonitis (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0778-2021 (December 1, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0778-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.