Early Alert Issued for Bard Peripheral Vascular’s Rotarex Atherectomy Systems

The U.S. FDA has issued an early alert for Rotarex Atherectomy Systems. According to the FDA, the helix portion of the device may be at risk for fracture or breakage under certain conditions. The lawyers at Johnson//Becker, PLLC, are investigating new cases involving Bard Peripheral Vascular’s Rotarex Atherectomy Systems.

Early Alert Issued for Bard Peripheral Vascular's Rotarex Atherectomy Systems
We have years of experience representing clients in medical device cases and understand the complexities involved in these claims.

What is the Issue?

On February 5, 2025, Becton, Dickinson and Company’s (BD) subsidiary Bard Peripheral Vascular sent its affected customers a Medical Device Correction letter. This is an official notification sent by a medical device manufacturer to inform healthcare providers, patients, or other stakeholders about a necessary correction or safety update related to a medical device.

Becton, Dickinson and Company has identified that “specific patient anatomical characteristics—such as vessel size, angle, twisting, and degree of calcification—along with procedural factors, including contralateral access, sheath kinking, lack of continuous blood flow, and catheter advancement-related factors, could contribute to helix fracture and/or breakage events.” The alert indicates that the helix (spinning) portion of the device rotates at a high rate of speed and may be at risk of fracture or breakage when exposed to certain stress, wear, high temperatures, friction, or localized pressure. A fracture or break could cause vessel injury and may lead to severe bleeding or death.

Becton, Dickinson and Company has reported at least 30 serious injuries and four deaths associated with this issue. BD has also reported at least 115 cases requiring additional intervention/care because of a fracture or breakage of the device.

Is My Device Included in this Early Alert?

A unique device identifier (UDI) helps identify individual medical devices sold in the United States. The affected UDIs are as follows:

Rotarex Description                        UDI

6 F x 110 cm                                       (01)07640142811855

6 F x 135 cm                                       (01)07640142811862

8 F x 85 cm                                          (01)07640142811879

8 F x 110 cm                                       (01)07640142811886

Questions About a Rotarex Atherectomy System Lawsuit? Contact a Johnson//Becker Lawyer for a Free Case Review

If you or a loved one underwent an atherectomy procedure using a Bard Peripheral Vascular device, and experienced bleeding, vascular injury, or required surgery to remove a broken device, the attorneys at Johnson//Becker are here to help. We have years of experience representing clients in medical device cases and understand the complexities involved in these claims.

We offer free case evaluations and can help determine whether you may be entitled to financial compensation for your or a loved one’s injuries. Contact us today by completing the form below or calling (800) 279-6386.

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