Boston Scientific Recalls

45 recalls found for Boston Scientific. Check if any of your products are affected.

Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Preventive Maintenance Kit SPRPM8000 Recalled for Hazardous Defect

Boston Scientific recalled 1 unit of the Preventive Maintenance Kit SPRPM8000 after certain desiccant tubes were built with incorrectly tightened end caps. This assembly defect can lead to device malfunction, posing a serious risk to patients. Healthcare providers and patients should stop using the device immediately and follow recall instructions from the manufacturer.

Boston Scientific
Certain desiccant
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific ICEfx Cryoablation System Recalled for 19 Units Worldwide (2025)

Boston Scientific recalled 19 ICEfx Cryoablation System units worldwide, including the United States, Canada, France, Germany and Italy. The recall concerns desiccant tube subassemblies with end caps that were not tightened. Clinicians and patients should stop using the device immediately and follow recall instructions issued by the manufacturer.

Boston Scientific
Certain desiccant
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific UroMax Ultra Kit MPNs Recalled Over Foreign Material Migration Risk (2025)

Boston Scientific recalled 1,369 Encore 26 Inflation Devices used with balloon dilation catheters after an internal investigation found foreign material particles could migrate into a balloon dilatation catheter. The recall affects 12 UPNs including M0062251200 through M0062251370. Patients and healthcare providers should stop using the device immediately and follow manufacturer instructions.

Boston Scientific
The Encore
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific Encore 26 Inflation Device Recalled Over Foreign Particle Contamination

Boston Scientific recalls 39,739 Encore 26 Inflation Devices worldwide after an internal investigation found foreign material particles could migrate from the device into balloon dilation catheters. The high-severity recall affects interventional cardiology and peripheral interventions devices. Stop using immediately and await recall instructions from Boston Scientific or healthcare providers.

Boston Scientific
The Encore
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Health & Personal Care
HIGH
FDA DEVICE

Boston Scientific NephroMax Kit Recall Covers 458 Units Over Foreign Material Migration Risk

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.

Boston Scientific
The Encore
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Brand Statistics

Total Recalls
45
Pages
3

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