Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.
Class IReported ongoing
Distribution: Worldwide Distribution. US nationwide. International distribution worldwide.
Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.
Class IReported ongoing
Distribution: Worldwide Distribution. US nationwide. International distribution worldwide.
Certain batches are being removed due to an increase in complaints received in which physicians encountered greater than anticipated resistance while attempting to withdraw the stent delivery system (SDS) from the guidewire or embolic protection device (EPD...
Class IReported ongoing
Distribution: Domestic US Nationwide distribution including Puerto Rico. International distribution worldwide.
The potentially impacted units were manufactured using specific equipment that may have caused cracks in the electrode bands on the catheter's distal end.
Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due t...
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Japan.
Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due t...
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Japan.
Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due t...
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Japan.
Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due t...
Class IIReported ongoing
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Japan.
Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon initial connection of an IceSeed CX need...
Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon initial connection of an IceSeed CX need...
Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon initial connection of an IceSeed CX need...
Boston Scientific has identified that IceSeedTM CX needles manufactured between April 2024 and February 2025 have been programmed with DEMO settings instead of Commercial settings (see Affected Product Listing). Upon initial connection of an IceSeed CX need...
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Class IIReported ongoing
Distribution: Nationwide including Puerto Rico Foreign: To be provided
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Class IIReported ongoing
Distribution: Nationwide including Puerto Rico Foreign: To be provided
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Class IIReported ongoing
Distribution: Nationwide including Puerto Rico Foreign: To be provided
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Class IIReported ongoing
Distribution: Nationwide including Puerto Rico Foreign: To be provided
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Class IIReported ongoing
Distribution: Nationwide including Puerto Rico Foreign: To be provided
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Class IIReported ongoing
Distribution: Nationwide including Puerto Rico Foreign: To be provided
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Class IIReported ongoing
Distribution: Nationwide including Puerto Rico Foreign: To be provided
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Class IIReported ongoing
Distribution: Nationwide including Puerto Rico Foreign: To be provided
Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.
Certain batches are being removed due to an increase in complaints received in which physicians encountered greater than anticipated resistance while attempting to withdraw the stent delivery system (SDS) from the guidewire or embolic protection device (EPD) after successful s...
The potentially impacted units were manufactured using specific equipment that may have caused cracks in the electrode bands on the catheter's distal end.
Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and var...
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Checking Boston Scientific Corporation
Is there a recall on boston scientific corporation right now?
This archive contains 354 records, including 352 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.
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Where can I find older records?
Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.