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All product recalls associated with Boston Scientific Corporation.
Total Recalls
546
Past Year
59
Class I (Serious)
3
Most Recent
Sep 2025
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
Product degradation-- a polymer portion of the distal section of the catheter may degrade prematurely, leading to potential systemic embolization of particulates with ischemic complications.
Boston Scientific is initiating a Recall Removal of numerous batches/lots of Equalizer Occlusion Balloon Catheter because the sterile barrier in the packaging of the affected product may be compromised. The outer pouch seal may be breached. If a compromised seal is not detected and a sterility-compromised catheter is used clinically, there is a risk of adverse health consequences.
Boston Scientific is initiating a Recall Removal of numerous batches/lots of Equalizer Occlusion Balloon Catheter because the sterile barrier in the packaging of the affected product may be compromised. The outer pouch seal may be breached. If a compromised seal is not detected and a sterility-compromised catheter is used clinically, there is a risk of adverse health consequences.