Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
BD Recanalization System Recalled by Bard Peripheral Vascular Inc Due to Recanalization systems may be in a manufacturing mode...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Bard Peripheral Vascular Inc directly.
Affected Products
BD Recanalization System, REF: BDRECANSYSTEM
Quantity: 403
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 33 states: AL, AZ, AR, CA, CO, DE, FL, GA, HI, IL, IN, IA, KS, KY, LA, ME, MD, MA, MN, MS, MO, NE, NV, NJ, NM, NY, NC, OH, PA, TX, VA, WI, DC
About Bard Peripheral Vascular Inc
Bard Peripheral Vascular Inc has 136 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report