Bard recalls specific recanalization systems that may run continuously without required pauses, increasing risk of overheating or breaking. Affected units have serial numbers starting with BSX000001 to BSX000444.
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.
Bard has recalled certain recanalization systems that may run continuously without the typical 30-second pauses and warning messages, which could cause overheating or breaking. This poses a risk during medical procedures.
The system may remain in a manufacturing mode that prevents it from pausing for 30 seconds and displaying the 4-minute warning/5-minute restart messages. This continuous operation could exceed the ten-minute maximum catheter use time, leading to overheating or device failure.
Healthcare professionals using the Bard Recanalization System for medical procedures are most at risk. Patients receiving treatment with the affected devices may also be impacted.
Check the serial number on the device, which starts with BSX000001 to BSX000444. The product reference is BDRECANSYSTEM with UDI-DI: 00801741202421.
Look for the serial number on the device, which starts with BSX000001 to BSX000444.
BD Recanalization System, REF: BDRECANSYSTEM
The device may overheat or break, increasing the risk of complications during medical procedures.
Check the serial number on the device; affected units have serial numbers starting with BSX000001 to BSX000444.
We’ve drafted a message you can send Bard to request your refund or repair — edit it as you like.
Subject: Recall Z-0676-2024 — Bard Bard Hello, I own a Bard that is covered by recall Z-0676-2024 from Bard. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
