Agency classClass IIOur severity:Severe FDA (Devices)·Z-0776-2021·Announced 2021-01-13

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

Boston Scientific is recalling 8 units of the Hot 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk of peritonitis, which is a serious medical condition, meeting the criteria for a Severe rating.

Plain-English summary

Boston Scientific Corporation is recalling 8 units of the Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm (OUS), UPN: M00553540. The recall involves Lot Number 26130517 with an expiration date of 10/5/2022. 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 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 this product should stop using it immediately and contact Boston Scientific Corporation for further instructions on return or disposal.

The recalled product

Product: 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.
Manufacturer: Boston Scientific Corporation
Category: Medical Device — Endoscopic Stent
Hazard: peritonitis
device-detachment
Affected units: 8

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 (1)

Lot Number: 26130517 Exp. Date Range: 10/5/2022 GTIN: 08714729904564

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