Agency classClass IIOur severity:Severe FDA (Devices)·Z-0775-2021·Announced 2021-01-13

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

Boston Scientific is recalling 38 units of AXIOS Stent and Electrocautery delivery systems 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 significant injury report criterion under the rubric.

Plain-English summary

Boston Scientific Corporation is recalling 38 units of the AXIOS Stent and Electrocautery - Enhanced Delivery System (20mm x10mm, UPN: M00553660). The affected lots are 26167271, 26152176, and 26167274, with expiration dates ranging from October 8, 2021, to October 12, 2021. The products were 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 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 should stop using the affected devices and contact Boston Scientific for further instructions. 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 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.
Manufacturer: Boston Scientific Corporation
Category: Medical Device — Endoscopic Stent
Hazard: peritonitis
device-detachment
Affected units: 38

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: 26167271
26152176
26167274 Exp. Date Range: 10/8/2021 10/12/2021 GTIN: 08714729951179

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