Boston Scientific has issued a warning letter recalling some of its Hurricane RX biliary balloon dilation catheters.
Marlborough, Massachusetts-based Boston Scientific issued the recall because of complaints received for pinholes in the balloon. The balloon could rapidly lose pressure or fail to maintain pressure due to the issue.
The recall out of Germany warns that the potential and most serious consequence of using the device is a prolonged procedure while the device is exchanged.
There have been no serious patient injuries reported to the company to date. The company advises users to immediately discontinue use of the Hurricane Rx dilation balloon catheters reported in the list and remove all affected units from inventories.
Boston Scientific’s Hurricane RX biliary balloon catheter is a double-lumen catheter for endoscopic dilation of strictures in the biliary tree and sphincter of Oddi, according to the company. It comes in a range of sizes to accommodate various patient anatomies and stricture sizes.
The following devices are affected:
- Hurricane RX dilation balloon 4mm, 2cm with an expiration date range of May 19, 2022 to May 13, 2023.
- Hurricane RX dilation balloon 4mm, 4cm with an expiration date range of May 10, 2022 to May 31, 2023.
- Hurricane RX dilation balloon 6mm, 2cm with an expiration date range of May 23, 2022 to May 28 2023.
- Hurricane RX dilation balloon 6mm, 4cm with an expiration date range of May 10, 2022 to May 26, 2023.
- Hurricane RX dilation balloon 6mm, 4cm with an expiration date range of May 10, 2022 to May 26, 2023.
- Hurricane RX dilation balloon 8mm, 2cm with an expiration date range of May 27, 2022 to May 26, 2023.
- Hurricane RX dilation balloon 8mm, 4cm with an expiration date range of May 18, 2022 to May 31, 2023.
- Hurricane RX dilation balloon 10mm, 2cm with an expiration date range of May 9, 2022 to May 27, 2023.
- Hurricane RX dilation balloon 10mm, 4cm with an expiration date range of May 18, 2022 to June 3, 2023.
