Boston Scientific recalls WallFlex Esophageal Stent Systems due to potential catheter tip detachment during delivery. Affected models include FC 18/23-25MMX10CM. Contact for return 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 certain WallFlex Esophageal Stent Systems because the delivery catheter tip might detach during use, which could cause serious injury. This recall affects patients with esophageal strictures or fistulas who use these stents.
The stent system has a potential for the delivery catheter tip to detach during insertion. This detachment could cause injury to the esophagus or other internal structures if it occurs during the procedure.
Patients with esophageal strictures or fistulas who use the WallFlex Esophageal Stent System are most at risk. The recall applies to specific model numbers and lot numbers listed in the notice.
Check for the model number FC 18/23-25MMX10CM on the stent system packaging or label. The affected units have specific lot numbers listed in the recall notice.
Verify the model number and lot numbers listed in the recall notice to confirm if your stent system is affected.
The recall is due to the potential for delivery catheter tip detachment during insertion, which could cause injury.
The recall notice does not specify a remedy; check the official notice for return or repair instructions.
Yes, the affected units include lot numbers 32779260, 32790021, 32817917, 32860922, 32906415, 32966005, 32967262, 33026701, 33026703, 33077154, 33077157, 33085584, 33147800, 33156072, 33218764, 33256093.
We’ve drafted a message you can send Boston Scientific to request your refund or repair — edit it as you like.
Subject: Recall Z-3275-2024 — Boston Scientific Boston Scientific Hello, I own a Boston Scientific that is covered by recall Z-3275-2024 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.
