Boston Scientific Recalls Hurricane RX Biliary Balloon Catheters Due to Detachment Risk
Boston Scientific is recalling Hurricane RX Biliary Balloon Dilatation Catheters because the black sheath may detach from the shaft. The recall covers 15,062 units in the US and 12,930 internationally.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall is classified as FDA Class II. The hazard involves a component detaching from a medical device used in a sensitive anatomical area, representing a risk of harm where injury has not yet been reported, which aligns with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Boston Scientific Corporation is recalling the Hurricane RX Biliary Balloon Dilatation Catheter. The recall is initiated because the RX tunnel component, specifically the black sheath, may detach from the catheter shaft due to lower bond strength. This device is a double lumen catheter with a balloon at the distal tip, used to dilate narrow duct segments and the Sphincter of Oddi.
The recall affects 15,062 devices distributed in the United States and 12,930 devices distributed outside the US. The distribution pattern is worldwide, including US nationwide and international markets. The affected catalog reference numbers are M00545890, M00545900, M00545910, M00545920, M00545930, M00545940, M00545950, and M00545960.
This recall is classified as Class II by the FDA. The source text does not report any specific injuries or illnesses associated with this defect. Healthcare providers and patients should contact Boston Scientific for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- Hurricane RX Biliary Balloon Dilatation Catheter Catalog REF No. M00545890; M00545900; M00545910; M00545920; M00545930; M00545940; M00545950; M00545960 The device is a double lumen catheter with a balloon mounted at the distal tip. Dilatation balloon catheters are used to…
- Manufacturer
- Boston Scientific Corporation
- Hazard
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 (20)
- 25536219
- 25612668
- 25649812
- 25344165
- 25344168
- 25366542
- 25366543
- 25379240
- 25379241
- 25392546
- 25447687
- 25447688
- 25447689
- 25447690
- 25447691
- 25447692
- 25453103
- 25453105
- 25453108
- 25466435
Distribution
Distributed nationwide across the United States.
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