WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
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: 231 units Lot/code info: GTIN: 08714729778035 Lot Numbers: 32779260, 32790021, 32817917, 32860922, 32906415, 32966005, 32967262, 33026701, 33026703, 33077154, 33077157, 33085584 33147800, 33156072, 33218764, 33256093
08714729778035
Official record: FDA (Device enforcement) ↗
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