Boston Scientific Corporation: 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

Agency Publication Date: January 6, 2021

Affected Products

Product: AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm UPN: M00553640 - 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.

Lot Number: 26134666 Exp. Date: 10/6/2022 GTIN:08714729904588

Lot Numbers:

Number

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.

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

Lot Numbers:

Number

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.

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

Lot Numbers:

Number

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.

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

Lot Numbers:

Number

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.

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

Lot Numbers:

Number

Product: Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm (OUS) UPN: M00553560 - 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.

Lot Number: 26167277, 26171099, 26152171, 26171383, 26171380, 26152172 Exp. Date Range: 10/8/2021 10/12/2021 GTIN: 08714729951100

Lot Numbers:

Number

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86909

Status: Resolved

Manufacturer: Boston Scientific Corporation

Manufactured In: United States

Units Affected: 6 products (13 units; 32 units; 38 units; 8 units; 61 units; 78 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Lot Number: 26134666 Exp. Date: 10/6/2022 GTIN:08714729904588

Lot Numbers:

Number

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

Lot Numbers:

Number

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

Lot Numbers:

Number

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

Lot Numbers:

Number

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

Lot Numbers:

Number

Lot Number: 26167277, 26171099, 26152171, 26171383, 26171380, 26152172 Exp. Date Range: 10/8/2021 10/12/2021 GTIN: 08714729951100

Lot Numbers:

Number