Boston Scientific HURRICANE RX Dilation Balloon Recalled for Pressure Loss
Boston Scientific is recalling HURRICANE RX Dilation Balloons due to a pinhole defect that causes pressure loss during endoscopic procedures. The device may fail to maintain necessary pressure, potentially prolonging procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with a pressure-loss defect that creates risk of harm during invasive endoscopic procedures, but no illnesses or injuries have been reported in the source material.
Plain-English summary
Boston Scientific Corporation is recalling the HURRICANE RX Dilation Balloon (10mm, 2cm), a medical device used for endoscopic dilation of strictures in the biliary tree and the Sphincter of Oddi. The devices are affected by a pinhole defect that causes loss of pressure or prevents the balloon from gaining or maintaining pressure during use.
The pressure loss caused by the defect results in prolonged procedures, as the balloon cannot maintain the necessary pressure for effective dilation. The recall encompasses 16 batch numbers with expiration dates ranging from May 9, 2022 to May 27, 2023, and affects devices distributed nationwide in the United States.
This is an FDA Class II medical device recall.
The recalled product
- Product
- HURRICANE RX DILATION BALLOON 10MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545950
- Manufacturer
- Boston Scientific Corporation
- Hazard
- device-malfunction
- pressure-loss
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (16)
- Batches: 25571372
- 25673064
- 25836146
- 26010398
- 26058426
- 26123197
- 26175501
- 26216321
- 26473779
- 26759413
- 26784680
- 26848732
- 26946145
- 27121592
- 27340635
- 27393787 GTIN: 08714729283867 Exp. 05/09/2022 to 05/27/2023
Distribution
Distributed nationwide across the United States.
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