Volcano Corp is recalling 233,817 Volcano Visions Digital IVUS Catheters because the catheter and guide wire can become entangled during medical procedures. This issue primarily occurs during radial-to-peripheral procedures when the device is used without an appropriate guide sheath or guide catheter. There have been reports of these entanglements, which may require surgical intervention to safely remove the trapped device from the patient.
The catheter and guidewire can twist or lock together inside the patient's blood vessels. If entanglement occurs, the device cannot be easily withdrawn, potentially resulting in serious injury and requiring surgery to remove the components.
Used with Instructions for use: 300004875732_A Revision Date: 03/2021, 300004410212.A Release Date: 03/2021
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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