Bard Peripheral Vascular Inc. is recalling 403 units of the BD Recanalization System (Model BDRECANSYSTEM) because the device may have been shipped in a manufacturing mode that disables critical safety features. This mode allows the system to run continuously without required 30-second pauses or necessary warning messages that inform medical staff when the 10-minute maximum catheter use time has been reached. Consumers and healthcare providers should be aware that this defect can lead to the device overheating or breaking during a medical procedure.
The lack of safety pauses and usage warnings may cause the device to exceed its operating limits, leading to mechanical failure or overheating. This increases the risk of the device breaking while inside a patient or causing thermal injury.
Contact healthcare provider or manufacturer
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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