Boston Scientific Esophageal Stent Systems Recalled for Catheter Detachment Risk
Boston Scientific is recalling WallFlex and Agile esophageal stent systems due to potential delivery catheter tip detachment. The recall affects 79 units 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: This is a risk-of-harm product where injury has not yet been reported, matching the High severity criterion. No illnesses, injuries, or deaths have been documented in the source.
Plain-English summary
Boston Scientific Corporation is recalling the WallFlex Esophageal Stent System and Agile Esophageal Over-the-Wire (OTW) Stent System. These devices are used to maintain patency in patients with esophageal strictures caused by malignant tumors or concurrent esophageal fistulas.
The recall affects 79 units with the following lot numbers: 32770266, 32780362, 32865975, 32906417, 32975732, 33017656, 33128876, and 33167135 (Material Number: M00516720).
The devices have been distributed worldwide, including throughout the United States and internationally to APAC (Asia-Pacific), Canada, EMEA (Europe, Middle East, Africa), and LATAM (Latin America) regions.
The recall is due to the potential for delivery catheter tip detachment during the device placement procedure.
The recalled product
- Product
- WALLFLEX ESOPHAGEAL FC 18/23-25MMX15CM- Agile Esophageal Partially Covered and Fully Covered OTW 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
- Hazard
- Affected units
- 79
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 (8)
- GTIN: 08714729778059 Lot Numbers: 32770266
- 32780362
- 32865975
- 32906417
- 32975732
- 33017656
- 33128876
- 33167135
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.
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Same hazard · catheter detachment
See all →- HighBoston Scientific Recalls WallFlex Esophageal Stent Systems Due to Catheter Tip Detachment
FDA (Devices) · 2024-10-02
- SevereBoston Scientific Recalls Agile Esophageal Stent Systems Due to Catheter Tip Detachment
FDA (Devices) · 2024-10-02
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FDA (Devices) · 2024-10-02
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FDA (Devices) · 2024-10-02
- HighBoston Scientific Recalls Agile Esophageal Stent Systems Due to Catheter Detachment Risk
FDA (Devices) · 2024-10-02
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