Boston Scientific recalls WallFlex PC Esophageal Stent Systems due to potential delivery catheter tip detachment. Affected units have specific lot numbers and model sizes. Consumers should contact the company for remedy details.
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
Boston Scientific is recalling WallFlex PC Esophageal Stent Systems that may have a delivery catheter tip that can detach during use. This could lead to serious complications if the stent becomes dislodged in the esophagus.
The stent system's delivery catheter tip may detach during insertion, potentially causing the stent to become dislodged in the esophagus. This could lead to serious complications such as blockages or injuries to the esophagus.
Patients who have received the WallFlex PC Esophageal Stent System (23/28mm x 105mm) with specific lot numbers listed in the recall are affected. Those who have undergone esophageal stent placement for strictures or fistulas are most at risk.
Check the product label for the model size (23/28mm x 105mm) and lot numbers listed: 32770265, 32799938, 32799939, 32809371, 32809372, 32957301, 33128874, 33156073, 33156074, 33156075, 33156076, 33233491, 33233492.
Reach out to Boston Scientific directly for specific instructions on how to return or replace the stent system.
The recall indicates a potential risk of delivery catheter tip detachment, so it is not recommended for use until the remedy is applied.
Affected lot numbers include 32770265, 32799938, 32799939, 32809371, 32809372, 32957301, 33128874, 33156073, 33156074, 33156075, 33156076, 33233491, 33233492.
Check the product label for the model size (23/28mm x 105mm) and the lot numbers listed in the recall.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-3284-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-3284-2024 from Boston Scientific. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
