Boston Scientific Corporation: WALLFLEX PC ESOPH STENT 23/28MM X 105MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is Intended for maintaining esophageal luminal patency in e

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: 133 units Lot/code info: GTIN: 08714729765271 Lot Numbers: 32770265, 32799938, 32799939 32809371, 32809372, 32957301 33128874, 33156073, 33156074 33156075, 33156076, 33233491 33233492

UPC codes

08714729765271

Source

Official record: FDA (Device enforcement) ↗

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