Boston Scientific Corp. recalls 458 NephroMax Kit units using Encore 26 Inflation Devices after an internal review found foreign material particles could migrate from the inflation device into balloon dilatation catheters. The recall affects UPNs M0062101180 and M0062101600 worldwide. Healthcare providers should stop using the device immediately and follow manufacturer recall instructions.
The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, foreign material particles could migrate from affected Encore 26 Inflation Devices into a balloon dilatation catheter.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Boston Scientific Corporation or your healthcare provider for instructions. Notification method: Letter
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NephroMax Kit with Encore 26 Inflation Device is used in urology to dilate and monitor pressure in balloons.
Particles could migrate from the inflation device into the catheter, potentially compromising device integrity or patient safety.
This recall is not part of a broader industry pattern; it is specific to this device line.
High risk in invasive procedures; immediate action required to prevent potential contamination of balloon dilatation catheters.
Official recall notice on FDA enforcement database and Boston Scientific communications.
Hospitals should contact Boston Scientific for replacement or corrective actions; timelines vary by facility.
Save all recall notices, correspondence, device serial numbers, and replacement acknowledgments
Product: Boston Scientific NephroMax Kit. UPNs: M0062101180; M0062101600. Category: Medical device. Stage: Recall active. Distribution: Worldwide. Quantity: 458 units. Affected area: Urology.
No specific incidents or injuries are cited in the provided recall notice.
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