WallFlex and Agile Esophageal Stent Systems Recalled for Catheter Tip Detachment
Boston Scientific recalls WallFlex and Agile Esophageal Stent Systems due to potential delivery catheter tip detachment. The affected stents treat esophageal strictures and may cause procedural complications if detachment occurs.
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 recall without reported hospitalizations or injuries. The hazard involves potential mechanical failure during a medical procedure without any actual adverse events reported, fitting the rubric criterion for High severity: 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Boston Scientific Corporation is recalling certain lots of the WallFlex Esophageal Stent System and Agile Esophageal Over-the-Wire (OTW) Stent System due to the potential for delivery catheter tip detachment during insertion.
These stent systems are designed to maintain esophageal luminal patency in patients with esophageal strictures caused by malignant tumors or esophageal fistulas. The recalled systems were distributed worldwide, including throughout the United States and in APAC, Canada, EMEA, and LATAM regions. Sixty-six units are affected across lot numbers 33017652, 33213399, 33256089, and 33275531.
If the delivery catheter tip detaches during insertion, it could compromise the proper placement of the stent or cause complications during the medical procedure. Patients who have received these stents should contact their healthcare provider. Healthcare facilities and physicians should immediately discontinue use of the affected lots and contact Boston Scientific for guidance.
Adverse events should be reported to the FDA's MedWatch program.
The recalled product
- Product
- WALLFLEX FC ESO STENT RMV 18X123MM-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
- 66
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 (4)
- GTIN: 08714729854487 Lot Numbers: 33017652
- 33213399
- 33256089
- 33275531
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 tip detachment
See all →- HighBoston Scientific Agile Esophageal Over-the-Wire Stent System recalled for catheter tip detachment
FDA (Devices) · 2024-10-02
- HighEsophageal Stent Systems Recalled Due to Catheter Detachment Risk
FDA (Devices) · 2024-10-02
- HighBoston Scientific Esophageal Stents Recalled for Delivery Catheter Tip Detachment
FDA (Devices) · 2024-10-02
- HighBoston Scientific esophageal stents recalled due to catheter tip detachment risk
FDA (Devices) · 2024-10-02
- HighWallFlex and Agile esophageal stent systems recalled for delivery catheter tip detachment
FDA (Devices) · 2024-10-02
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