Boston Scientific recalls Wallflex Esophageal Stent Systems due to potential catheter tip detachment during delivery. Affected models include FC ESO STENT RMV LL 23X155. Contact for return or repair instructions.
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 Esophageal Stent Systems that may have a catheter tip that detaches during delivery. This could cause serious injury if the stent moves incorrectly in the esophagus.
The catheter tip may detach during stent delivery, causing the stent to move incorrectly in the esophagus. This could lead to injury if the stent shifts position.
Patients who have received the Wallflex FC ESO STENT RMV LL 23X155 model for esophageal strictures or fistulas are affected. Those with esophageal tumors or strictures are at higher risk.
Check for the model number M00516320 on the packaging or label. The product was sold with lot numbers 32753933, 32937357, 32987960, or 33218763.
Look for the model number M00516320 and lot numbers 32753933, 32937357, 32987960, or 33218763 on the packaging or label.
The model number is M00516320.
Lot numbers 32753933, 32937357, 32987960, and 33218763 are affected.
The recall record does not specify a remedy.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-3274-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-3274-2024 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
