Boston Scientific Corporation is recalling 18 units of the ICEfx Cryoablation System and one Preventive Maintenance Kit because internal desiccant tube caps were not correctly tightened during manufacturing. The ICEfx system is a portable medical device used to perform cryoablation, a procedure that uses extreme cold to destroy diseased tissue. If these caps are loose, the system may malfunction or fail, potentially interrupting medical procedures.
Improperly tightened end caps on the desiccant tube subassemblies can lead to system failure. This defect could cause the device to become inoperable during a procedure, requiring clinical intervention or a switch to an alternative treatment method.
18 units affected.
1 unit affected; distributed to Canada only.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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