Agency classClass IIOur severity:High FDA (Devices)·Z-3285-2024·Announced 2024-10-02

Esophageal Stent System Recalled Due to Potential Catheter Tip Detachment

Boston Scientific recalls WallFlex and Agile esophageal stent systems (305 units) due to potential delivery catheter tip detachment. Affected products were distributed worldwide.

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: FDA Class II medical device with potential for delivery catheter tip detachment. No reported injuries, hospitalizations, or deaths. The source describes a risk-of-harm product where injury has not yet been reported, meeting the criteria for score 3 (High).

Plain-English summary

Boston Scientific Corporation is recalling the WallFlex Esophageal Stent System and the Agile Esophageal Over the Wire (OTW) Stent System. These devices are intended to maintain esophageal luminal patency in esophageal strictures caused by malignant tumors or fistulas.

The recall is due to the potential for delivery catheter tip detachment. Approximately 305 units were distributed worldwide, including across the United States, Asia-Pacific, Canada, Europe/Middle East/Africa, and Latin America.

Healthcare providers and patients who have received these stent systems should contact Boston Scientific Corporation for guidance. Multiple lot numbers of the WallFlex system are affected, including batches 32759900, 32759903, 32789717, 32789718, 32829629, 32847692, 32848481, 32898067, 32919347, 32927195, 32949480, 32956257, 32957302, 32965072, 32985475, 32987961, 33047928, 33145976, 33145978, 33208046, 33208048, 33242626, and 33275535.

The recalled product

Product: WALLFLEX PC ESOPH STENT 23/28MM X 125MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent…
Manufacturer: Boston Scientific Corporation
Category: Medical Device — Esophageal Stent System
Hazard: device-component-detachment
device-failure
Affected units: 305

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 (16)

GTIN: 08714729765288 Lot Numbers: 32759900
32759903
32789717 32789718
32829629
32847692 32848481
32898067
32919347 32927195
32949480
32956257 32957302
32965072
32985475 32987961
33047928
33145976 33145978
33208046
33208048 33242626
33275535

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 31 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 31 products in this recall →

Same manufacturer · Boston Scientific Corporation

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Same hazard · device component detachment