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: 297 units Lot/code info: GTIN: 08714729765240 Lot Numbers: 32759902, 32780160, 32830094, 32865976, 32868557, 32875121, 32891029, 32898065, 32898066, 32906414, 32915745, 32938540 32966004, 32977682, 32985473, 33026702, 33026704, 33036452, 33036453, 33045964, 33056440, 33119731, 33120913, 33167136 33169265, 33169266, 33169267
08714729765240
Official record: FDA (Device enforcement) ↗
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