Medical Device Recall: BD Recanalization System, REF: BDRECANSYSTEM
Bard Peripheral Vascular Inc · November 14, 2023
Reason for Recall
Recanalization systems may be in a manufacturing mode that allows the system to continuously run without the typical 30 second pauses, and 4-minute warning/5-minute restart required messages to indicate the ten-minute maximum catheter use time has been exceeded, which may increase the risk of the device overheating or breaking.
Distribution
US: CA, OH, PA, NY, TX, NJ, MS, IL, GA, AL, AZ, NC, NV, PR, IN, MA, WI, KS, AR, FL, MD, IA, NE, LA, HI, MO, DE, DC, VA, NM, CO, KY, ME, MN
States Affected
AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, PA, TX, VA, WI
Quantity Affected
403
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0676-2024
Status: ongoing
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