Boston Scientific recalls WallFlex and Agile esophageal stents for delivery catheter detachment
Boston Scientific has recalled 308 units of WallFlex and Agile esophageal stent systems due to the potential for delivery catheter tip detachment during stent placement. The affected devices are distributed worldwide.
What this means for you
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 Class II FDA recall of a medical device with a specific potential hazard—delivery catheter tip detachment—that could compromise clinical outcomes. No illnesses or injuries have been reported in the source text, but the hazard involves a device failure during an invasive procedure used in high-risk patients, meeting the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Boston Scientific has recalled 308 units of WallFlex Esophageal Stent System and Agile Esophageal Over the Wire (OTW) Stent System. These stents are designed to maintain esophageal passage in patients with strictures caused by malignant tumors or concurrent esophageal fistulas.
The recall was initiated due to the potential for delivery catheter tip detachment during stent placement. If the catheter tip detaches during the delivery procedure, it could compromise the ability to properly position the stent and create a risk to patient safety.
The recall affects 308 units with specific lot numbers distributed worldwide, including the United States and countries in Asia-Pacific, Canada, Europe, Middle East and Africa, and Latin America. The FDA has classified this as a Class II recall.
Patients and healthcare providers with affected devices should contact their healthcare provider or Boston Scientific for guidance on next steps.
The recalled product
- Product
- WALLFLEX PC ESOPH STENT 18/23MM X 123MM- 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 esophag
- Manufacturer
- Boston Scientific Corporation
- Hazard
- delivery-catheter-detachment
- device-failure
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 (19)
- GTIN: 08714729765257 Lot Numbers: 32780161
- 32827704
- 32875120
- 32876612
- 32915744
- 32946076
- 32967272
- 32967273
- 33014124
- 33030431
- 33045961
- 33077152 33128873
- 33146800
- 33176330
- 33195047
- 33226266
- 33233489
- 33256090
- 33256091
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03