CLASS II Device recall · Reported 13 Jan 2021 · FDA Enforcement Report
Hot Axios Stent and Electrocautery recalled by Boston Scientific
Boston Scientific is recalling Hot Axios Stent and Electrocautery - Enhanced Delivery System (OUS) UPN: M00553550, distributed nationwide in the US. The recall was initiated on 1 Dec 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0777-2021
- FDA event ID
- 86909
- Recalling firm
- Boston Scientific, Marlborough, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 1 Dec 2020
- FDA classified
- 6 Jan 2021
- Reported
- 13 Jan 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 1 Dec 2020 | Recall initiated by company | |
| 6 Jan 2021 | Classified by FDA | +36 days |
| 13 Jan 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution - Foreign: TBD.
Questions about this recall
Is Hot Axios Stent and Electrocautery - Enhanced Delivery System (OUS) UPN: M00553550 recalled?
Yes. Boston Scientific recalled Hot Axios Stent and Electrocautery - Enhanced Delivery System (OUS) UPN: M00553550 on 1 Dec 2020. The recall is Class II and its status is Terminated. Recall number Z-0777-2021.
Why was it recalled?
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
Which lots are affected?
Lot Number: 26156059, 26167275, 26167276, 26156742, 26156740 Exp Date: 10/9/2022 10/12/2022 GTIN: 08714729904571
Where was it sold?
US Nationwide distribution - Foreign: TBD.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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