Agency classClass IIOur severity:High FDA (Devices)·Z-0777-2021·Announced 2021-01-13

Boston Scientific Recalls Hot AXIOS Stent Delivery Systems Due to Fitting Detachment

Boston Scientific is recalling Hot AXIOS Stent delivery systems because a fitting may detach, risking leakage of bodily contents into the peritoneal cavity.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product where injury has not yet been reported, specifically the risk of peritonitis from leakage of bodily contents.

Plain-English summary

Boston Scientific Corporation is recalling 61 units of the Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm (OUS). The affected units are identified by lot numbers 26156059, 26167275, 26167276, 26156742, and 26156740, with expiration dates of 10/9/2022 and 10/12/2022. The product was distributed nationwide in the United States.

The recall was initiated because 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. This defect may result in a delay to the procedure or a risk of peritonitis developing from the leakage of enteric, pseudocyst, or biliary contents into the peritoneal cavity.

Healthcare providers and facilities should stop using the affected units and contact Boston Scientific for instructions on return or replacement. The stent is intended for implantation up to 60 days and should be removed upon confirmation of pseudocyst or walled-off necrosis resolution.

The recalled product

Product: 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.
Manufacturer: Boston Scientific Corporation
Category: Medical Device — Endoscopic Stent
Hazard: peritonitis
leakage
mechanical-failure
Affected units: 61

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

Lot Number: 26156059
26167275
26167276
26156742
26156740 Exp Date: 10/9/2022 10/12/2022 GTIN: 08714729904571

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Same manufacturer · Boston Scientific Corporation

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Same hazard · peritonitis