Agency classClass IIOur severity:High FDA (Devices)·Z-0774-2021·Announced 2021-01-13

Boston Scientific Recalls AXIOS Stent Delivery System Due to Fitting Detachment Risk

Boston Scientific is recalling 32 units of the AXIOS Stent and Electrocautery - Enhanced Delivery System because a fitting may detach, risking peritonitis.

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 peritonitis, a serious medical condition, but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Boston Scientific Corporation is recalling 32 units of the AXIOS Stent and Electrocautery - Enhanced Delivery System (10mm x15mm, UPN: M00553650). The affected lots are 26152465, 26152466, and 26152467, with an expiration date of 10/8/2022. The product was distributed nationwide in the US.

The recall is due to a defect where 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 detachment can result in a delay of 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 that have received these specific units should stop using them and contact Boston Scientific for instructions on return or disposal. 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: 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.
Manufacturer: Boston Scientific Corporation
Category: Medical Device — Gastroenterology
Hazard: peritonitis
device-failure
Affected units: 32

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 (3)

Lot Number: 26152465
26152466
26152467 Exp. Date: 10/8/2022 GTIN: 08714729904595

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