Boston Scientific Corporation: WALLFLEX FC ESO STENT RMV 23X125MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in

Hazard

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

Details from the source

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. Distribution: Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM. Quantity: 176 units Lot/code info: GTIN: 08714729854517 Lot Numbers: 32809368, 32846904, 32856377, 32867089, 32898068, 32908416, 32914771, 32919348, 32938992, 33058575

UPC codes

08714729854517

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.