Wallflex and Agile Esophageal Stents Recalled for Catheter Tip Detachment Risk
Boston Scientific recalls Wallflex FC and Agile Esophageal Stent Systems due to the potential for delivery catheter tip detachment during use. Approximately 145 units are affected 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 an FDA Class II medical device recall involving a potential mechanical defect (catheter tip detachment) that poses a risk of harm during device use. No illnesses, injuries, or deaths have been reported. The recall addresses a risk-of-harm scenario without documented adverse events, meeting the criteria for Score 3 (High).
Plain-English summary
Boston Scientific Corporation is recalling the Wallflex FC (Fully Covered) Esophageal Stent System and the Agile Esophageal Over the Wire (OTW) Stent System. These devices are intended for maintaining esophageal patency in patients with esophageal strictures caused by malignant tumors or concurrent esophageal fistulas.
The recall is issued due to the potential for the delivery catheter tip to detach during the stent placement or removal procedure.
Approximately 145 units have been distributed worldwide, including throughout the United States and in APAC, Canada, EMEA, and LATAM regions. The affected lot numbers are: 32752366, 32752367, 32789716, 32919840, 32927193, 32956258, 32994874, and 33056529.
Healthcare providers should verify lot numbers before use and contact Boston Scientific Corporation or the FDA for further guidance regarding affected units.
The recalled product
- Product
- WALLFLEX FC ESO STENT RMV 23X155MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System 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
- Affected units
- 145
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: 08714729854524 Lot Numbers: 32752366
- 32752367
- 32789716
- 32919840
- 32927193
- 32956258
- 32994874
- 33056529
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 →Related recalls
Same manufacturer · Boston Scientific Corporation
See all →- ModerateBoston Scientific Recalls NaviFlex LW Pusher and Advx Panc. Stent
FDA (Devices) · 2026-10-21
- SevereBoston Scientific Recalls Imager II Angiographic Catheters Due to Tip Fracture Risk
FDA (Devices) · 2026-09-30
- ModerateBoston Scientific StoneSmart Connect Console Power Adapter Recall
FDA (Devices) · 2026-09-23
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
- HighBoston Scientific Recalls LUX-Dx Insertable Cardiac Monitor Server Software
FDA (Devices) · 2026-09-09
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
- HighBoston Scientific Recalls WallFlex Esophageal Stents Due to Catheter Tip Detachment
FDA (Devices) · 2024-10-02
- HighBoston Scientific Recalls Agile Esophageal Stent Systems Due to Catheter Tip Detachment
FDA (Devices) · 2024-10-02
- HighBoston Scientific Recalls Agile Esophageal Stent Systems Due to Catheter Detachment Risk
FDA (Devices) · 2024-10-02
Similar recalls
- HighHOT AXIOS Stent System Recalled Due to Outer Sheath Detachment Risk
FDA (Devices) · 2025-02-05
- HighBoston Scientific HOT AXIOS Stent Delivery Systems Recalled for Component Detachment
FDA (Devices) · 2025-02-05
- ModerateBoston Scientific Recalls Mislabeled WallFlex Biliary Stent Systems
FDA (Devices) · 2020-09-23
- HighStent system outer sheath may detach, preventing proper expansion
FDA (Devices) · 2025-02-05
- HighAXIOS Stent Delivery System recalled due to distal sheath detachment
FDA (Devices) · 2025-02-05
- HighAXIOS Stent Distal Tip Detachment Prevents Proper Expansion
FDA (Devices) · 2025-02-05