Boston Scientific esophageal stent systems recalled for catheter tip detachment
Boston Scientific is recalling Wallflex and Agile esophageal stent systems due to potential delivery catheter tip detachment during stent placement procedures.
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 involving potential device malfunction with no reported injuries or hospitalizations. The hazard is theoretical—a risk-of-harm scenario where injury has not yet been reported. Per the severity rubric, such products score 3 (High).
Plain-English summary
Boston Scientific Corporation is recalling Wallflex Esophageal Stent Systems and Agile Esophageal Over-the-Wire (OTW) Stent Systems. These devices maintain esophageal patency in patients with esophageal strictures caused by intrinsic or extrinsic malignant tumors, or occlusion of esophageal fistulas.
The recall is due to the potential for delivery catheter tip detachment. During the stent placement procedure, the catheter tip may detach.
Affected units include 507 devices distributed worldwide, including in the United States, Asia-Pacific, Canada, Europe/Middle East/Africa, and Latin America. Specific lot numbers have been identified.
The recalled product
- Product
- WALLFLEX ESOPHAGEAL FC 23/28MMX12CM- 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 esophageal…
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 507
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 (20)
- GTIN: 08714729778073 Lot Numbers: 32771050
- 32771051
- 32789719
- 32790020
- 32827713
- 32837013
- 32837014
- 32846903
- 32856378
- 32875122
- 32876614
- 32888839 32906418
- 32914770
- 32919349
- 32927196
- 32928279
- 32938993
- 33014831
- 33038108
- 33101459
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
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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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