FDA Recalls Hurricane RX Dilation Balloons for Pressure Failure Risk

Plain-English summary

Boston Scientific Corporation is recalling certain Hurricane RX Dilation Balloons (10mm diameter, 4cm length) with UPN M00545960. These medical devices are intended for endoscopic dilation of strictures in the biliary tree and sphincter of Oddi.

The recall was issued due to defects in certain balloons that cause pinhole leaks resulting in pressure loss or failure to gain or maintain pressure during use. When pressure cannot be achieved or maintained, the balloon cannot perform its intended dilation function, potentially resulting in prolonged or failed procedures.

The recall affects 176 batches of the device distributed nationwide across the United States. Affected batches range from 25608761 through 27384710, with expiration dates from May 18, 2022 to June 3, 2023.

The recalled product

Product

HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545960

Manufacturer

Boston Scientific Corporation

Category

Medical Device — Endoscopic Dilation

Hazard

• pressure-loss
• device-malfunction

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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