CLASS II ONGOING Device recall · Reported 2 Oct 2024 · FDA Enforcement Report
Wallflex PC Esoph Stent- Wallflex Esophageal Partially recalled
Boston Scientific is recalling Wallflex PC Esoph Stent- Wallflex Esophageal Partially Covered and Fully Covered Stent, distributed nationwide in the US. The recall was initiated on 1 Aug 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3286-2024
- FDA event ID
- 95124
- Recalling firm
- Boston Scientific, Marlborough, MA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Aug 2024
- FDA classified
- 26 Sep 2024
- Reported
- 2 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 1 Aug 2024 | Recall initiated by company | |
| 26 Sep 2024 | Classified by FDA | +56 days |
| 2 Oct 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Product as listed by the FDA
WALLFLEX PC ESOPH STENT 23/28MM X 155MM- 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 fistulas Material Number (UPN): M00516950
Where it was distributed
Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.
Questions about this recall
Is Wallflex PC Esoph Stent- Wallflex Esophageal Partially Covered and Fully Covered Stent recalled?
Yes. Boston Scientific recalled Wallflex PC Esoph Stent- Wallflex Esophageal Partially Covered and Fully Covered Stent on 1 Aug 2024. The recall is Class II and its status is Ongoing. Recall number Z-3286-2024.
Why was it recalled?
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Which lots are affected?
GTIN: 08714729765295 Lot Numbers: 32764205, 32764206, 32827703 32837016, 32837017, 32850357 32869530, 32876613, 32891019 32900187, 32938379, 33145977 33160189, 33167134, 33242627
Where was it sold?
Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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