Boston Scientific Hydratome RX Devices Recalled Due to Sterile Barrier Breach
Boston Scientific is recalling Hydratome RX 44-30MM/260CM devices due to a sterile barrier breach that could compromise device sterility. The recall affects 3,371 units distributed worldwide.
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: This is an FDA Class II recall affecting a sterile medical device. Although no illnesses or injuries have been reported, the sterile barrier breach creates a significant risk of infection or contamination, qualifying as a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Boston Scientific Corporation is recalling Hydratome RX 44-30MM/260CM medical devices (Material Number M00583050) due to a compromise in the sterile barrier of the device.
The sterile barrier is designed to maintain the device in a sterile condition until it is used. A breach of this barrier means the device may no longer be sterile, which could allow contamination.
This recall affects 3,371 units distributed worldwide, including the United States and multiple countries. The affected lot numbers are: 27503545, 27539248, 27622371, 27830206, 27836999, 27892995, and 27940790.
Healthcare providers and patients who have received this device should contact Boston Scientific Corporation for instructions on how to proceed.
The recalled product
- Product
- HYDRATOME RX 44-30MM/260CM Material Number: M00583050
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device
- Affected units
- 3,371
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 31 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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