Bard Recanalization System: Risk of overheating or breaking due to continuous operation
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.
Use caution until it’s fixed
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.
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/56869-bard-recanalization-system-risk-of-overheating-or-breaking-due-to.
Source Summary by GovInfoNow · govinfonow.com/recall/56869-bard-recanalization-system-risk-of-overheating-or-breaking-due-to · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0676-2024
Cite this page
“Bard Recanalization System: Risk of overheating or breaking due to continuous operation.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56869-bard-recanalization-system-risk-of-overheating-or-breaking-due-to. Based on FDA recall #Z-0676-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0676-2024%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
Check the serial number on the device, which starts with BSX000001 to BSX000444. The product reference is BDRECANSYSTEM with UDI-DI: 00801741202421.
- Brand
Bard- Category
Medical device
What to do — step by step
Check Serial Number
Look for the serial number on the device, which starts with BSX000001 to BSX000444.
Where it went and when
Where it was distributed
Distributed in 32 states and D.C. and Puerto Rico.
FDA 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 read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Arizona, Arkansas, California, Colorado, Delaware, District of Columbia, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Jersey, New Mexico, New York, North Carolina, Ohio, Pennsylvania, Puerto Rico, Texas, Virginia, Wisconsin.
Recall timeline
FDA published this recall 2 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-0676-2024 (November 14, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0676-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.