Bard recalls Rotarex Atherectomy Systems with specific model numbers due to risk of catheter breakage causing vessel injury and severe bleeding during medical procedures.
Atherectomy Catheter eIFU updated to clarify and emphasize procedural steps intended to reduce the likelihood of catheter breakage events. Catheter has an outer cylinder connected to a rotating helix, which could fracture and/or break, which would require retrieval, and helix facture/break could cause vessel injury and lead to severe bleeding.
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Contact the company
📍Recalling firmBard Peripheral Vascular Inc1625 W 3rd St Bldg 1, 850 W. Rio Salado Prkwy. · Tempe, AZ 85281-2438
✎ GovInfoNow plain-language explainer
Bard is recalling certain Rotarex Atherectomy Systems that could break during use, potentially causing vessel injury and severe bleeding. This recall affects specific model sizes and versions of the device used in medical procedures. Read more at govinfonow.com/recall/52970-bard-rotarex-atherectomy-system-catheter-breakage-risk.
“Bard Rotarex Atherectomy System: Catheter Breakage Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52970-bard-rotarex-atherectomy-system-catheter-breakage-risk. Based on FDA recall #Z-1244-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1244-2025%22&limit=1).
The FDA announced on Feb. 5, 2025, that Bard Peripheral Vascular Inc is recalling Rotarex Atherectomy Systems due to a risk of catheter breakage. The agency says the hazard could cause vessel injury and severe bleeding.
How to tell if you have it
Brand: Bard
Product: Rotarex Atherectomy System
BD SET Rotarex S 6 F x 110 cm, REF: 80236
BD SET Rotarex S 6 F x 135 cm, REF: 80237
BD SET Rotarex S 8 F x 85 cm, REF: 80238
BD SET Rotarex S 8 F x 110 cm, REF: 80239
Instructions for Use versions prior to ZE10895 revision C1 09/24
The hazard
The atherectomy catheter's outer cylinder connected to a rotating helix could fracture or break. This failure would require retrieval and could cause vessel injury leading to severe bleeding.
Context
GovInfoNow's records show Bard Peripheral Vascular Inc has had 40 other recalls since Sept. 22, 2017. Other recent recalls of similar products include Boston Scientific Imager II Angiographic Catheters (Aug. 24, 2026) and Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus (July 9, 2026).
How to tell if you have this one
Check for model numbers: S 6 F x 110 cm (REF: 80236), S 6 F x 135 cm (REF: 80237), S 8 F x 85 cm (REF: 80238), or S 8 F x 110 cm (REF: 80239). Also check if the Instructions for Use version is prior to ZE10895 revision C1 09/24.
Brand
Bard
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Device Model
Identify the model number and reference code on the device or packaging to confirm if it is recalled.
Review Instructions for Use
Ensure the Instructions for Use version is not prior to ZE10895 revision C1 09/24, as older versions may have the risk.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 44 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide Distribution: NY, VA, KY, IN, OR, FL, MD, NJ, LA, CO, PR, PA, MS, MI, TX, KS, IL, CA, GA, OH, AL, NC, ND, AZ, SC, TN, UT, AR, WI, SD, MA, MO, ME, DE, WV , NV, NH, MN, CT, NE, IA, NM, WA, HI, and OK” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.
Recall timeline
FDA published this recall 35 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-1244-2025 (February 5, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1244-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.