HURRICANE RX DILATION BALLOON 8MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545930
Check against the official notice below — it lists the full affected range.
Boston Scientific Corporation is recalling Hurricane RX Dilation Balloons (8mm, 2cm) used for endoscopic procedures to dilate strictures in the biliary tree and Sphincter of Oddi. The balloons are affected by a defect where a pinhole in the balloon causes it to lose pressure or fail to gain or maintain proper pressure, potentially resulting in prolonged medical procedures. The recall affects 18 specific batch numbers with expiration dates ranging from May 2022 to May 2023, distributed nationwide across the United States.
If you have one of the affected balloons (identified by GTIN 08714729283843 and one of the listed batch numbers), the recall notice does not specify what action you should take or provide instructions for a remedy.
Written by software from the official notice below. Not reviewed by a lawyer.
Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure
Reason for recall: Balloon pinhole results in losss pressure or fails to gain or maintain pressure, causing prolonged procedure Distribution: US Nationwide distribution. Lot/code info: Batches: 25644951, 25649190, 25650286, 25651334, 25654287, 25947916, 25947918, 26010397, 26058298, 26406532, 26435581, 26449368, 26533973, 26555544, 26868194, 27074110, 27269956, 27384708. GTIN: 08714729283843 Exp. 05/27/2022 to 05/26/2023
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.