CLASS II ONGOING Device recall · Reported 2 Oct 2024 · FDA Enforcement Report
Wallflex FC Eso Stent Rmv LL recalled by Boston Scientific
Boston Scientific is recalling Wallflex FC Eso Stent Rmv LL - Wallflex Esophageal Partially Covered (PC) and Fully, 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-3271-2024
- 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 FC ESO STENT RMV LL 18X103- 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 esophageal fistulas Material Number (UPN): M00516270
Where it was distributed
Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.
Questions about this recall
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: 08714729905523 Lot Numbers: 32837018, 32946075, 33014125, 33218762
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
30 other products · FDA event 95124More recalls from Boston Scientific
All 626| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS I | Enroute Transcarotid Neuroprotection System recalled | Boston Scientific | Other | Nationwide |
| Device | CLASS I | Enroute Transcarotid Neuroprotection System Plus recalled | Boston Scientific | Other | Nationwide |
Other Heart & Vascular Devices recalls
All 6,199| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |