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.
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.
The catheter has an outer cylinder connected to a rotating helix that can fracture or break during use. If the helix breaks, it may cause vessel injury and lead to severe bleeding requiring immediate medical attention.
Medical professionals using the Rotarex Atherectomy System for vascular procedures are most at risk. Patients undergoing these procedures with the recalled devices may face complications.
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.
Identify the model number and reference code on the device or packaging to confirm if it is recalled.
Ensure the Instructions for Use version is not prior to ZE10895 revision C1 09/24, as older versions may have the risk.
The recall is due to a risk that the catheter could break during use, potentially causing vessel injury and severe bleeding.
The affected models are S 6 F x 110 cm (REF: 80236), S 6 F x 135 cm (REF: 80237), S 8 F x 85 cm (REF: 80238), and S 8 F x 110 cm (REF: 80239) with Instructions for Use versions prior to ZE10895 revision C1 09/24.
No, but medical professionals should check if their device is recalled and follow the instructions for use to reduce the risk of breakage.
We’ve drafted a message you can send Bard to request your refund or repair — edit it as you like.
Subject: Recall Z-1244-2025 — Bard Bard Hello, I own a Bard that is covered by recall Z-1244-2025 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.
