Hurricane RX (balloon bile dilation catheter)

2021: Withdrawal of defective products

In late October 2021, Boston Scientific issued a letter warning of the recall of some catheters for balloon dilatation of the Hurricane RX bile tract. The company announced the recall due to complaints received about punctures in the cylinder.

Boston Scientific explained that due to this problem, the cylinder can quickly lose pressure or not maintain it. Feedback from Germany warns that the potential and most serious consequence of using Hurricane RX is a lengthy replacement procedure.

Boston Scientific recalls defective balloon catheters due to holes in them

The Hurricane RX balloon dilatation catheter is a double lumen catheter with a balloon mounted at the distal end. Balloon dilation device is designed to use radial force to stretch narrow segments of ducts and sphincter.

According to Boston Scientific, the Hurricane RX bile tract balloon dilatation device is a double lumen catheter with a balloon mounted at the distal end. Balloon dilation device is designed to use radial force to stretch narrow segments of ducts and sphincter. The Hurricane RX bile tract balloon dilatation catheter can also be used for contrast agent administration during bile duct X-ray imaging.

As of October 28, 2021, the company did not receive reports of serious patient injuries. Boston Scientific advises users to immediately stop using Hurricane RX catheters with dilatation cylinders listed and remove all affected devices from stock.^[1]

Revocation Device List:

• Hurricane RX dilatation cylinder 4 mm, 2 cm with shelf life from May 19, 2022 to May 13, 2023;
• Hurricane RX dilation balloon 4mm, 4cm with expiration date from May 10, 2022 to May 31, 2023;
• Hurricane RX ball for expansion 6 mm, 2 cm with shelf life from May 23, 2022 to May 28, 2023;
• Hurricane RX ball for expansion 6 mm, 4 cm with shelf life from May 10, 2022 to May 26, 2023;
• Hurricane RX ball for expansion 6 mm, 4 cm with shelf life from May 10, 2022 to May 26, 2023;
• Hurricane RX ball for expansion 8 mm, 2 cm with shelf life from May 27, 2022 to May 26, 2023;
• Hurricane RX cylinder for expansion 8 mm, 4 cm with shelf life from May 18, 2022 to May 31, 2023;
• Hurricane RX ball for expansion 10 mm, 2 cm with shelf life from May 9, 2022 to May 27, 2023;
• Hurricane RX dilatation cylinder 10 mm, 4 cm with shelf life from May 18, 2022 to June 3, 2023.

Notes