Recall database

Catheter, Peripheral, Atherectomy recalls

Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.

Showing 1–2 of 2 recalls

Class IOngoingZ-1244-2025

Bard Peripheral Vascular Inc recalls Rotarex Atherectomy System and Instructions for Use

Atherectomy Catheter eIFU updated to clarify and emphasize procedural steps intended to reduce the likelihood of catheter breakage events.…

Atherectomy Peripheral Catheter
Under Investigation by firm

Bard Peripheral Vascul…AZMar 12, 2025

Class IIOngoingZ-0770-2025

Angiodynamics, Inc. recalls AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100

Potential for procedural delays or interruptions during use of the Auryon Atherectomy System due to the Auryon Atherectomy System not advancing to the Activation (Ready) mode.

Atherectomy Peripheral Catheter
Under Investigation by firm

Angiodynamics, Inc.NYJan 8, 2025