Source: US Department of Health and Human Services – 3
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. This recall involves updating the Instructions for using these devices and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without following the updated instructions. The affected products and recommendations for what to do with the devices below have not changed.
Affected Product
The FDA is aware that Bard Peripheral Vascular, a subsidiary of Becton, Dickinson and Company (BD), has issued a letter to affected customers providing updated instructions for use for Rotarex Atherectomy Systems (as shown in Figure 1)
SET Rotarex Description
UDI-DI
Catalog Number
Distribution
6 F x 110 cm
(01)07640142811855
80236
US Distribution
6 F x 135 cm
(01)07640142811862
80237
US Distribution
8 F x 85 cm
(01)07640142811879
80238
US Distribution
8 F x 110 cm
(01)07640142811886
80239
US Distribution
What to Do
On February 5, 2025, BD sent all affected customers a Medical Device Correction letter recommending the following actions:
Review the updated electronic Instructions for Use (eIFU) for Rotarex Atherectomy System, ZE10895 revision C1 09/24, in its entirety, which can be found on BD’s website.
Review the updated online, on-demand training on the safe and effective use of the Rotarex Atherectomy System, reflecting the recent eIFU updates by registering on the BD Learning Academy Learning Management System.
Post BD’s “Urgent: Medical Device Correction” notice with the stored product as evidence of the updated eIFU.
BD has identified that certain patient anatomical characteristics, including vessel size, angulation, tortuosity, degree of calcification, and procedural factors such as contralateral access, sheath kinking, lack of continuous blood flow, and catheter advancement related factors, could contribute to helix fracture and/or breakage events. BD is continuing to investigate what contributing factors exist that may have resulted in reported failure and/or breakage events. Updates to the Warnings section of the eIFU for US distributed Rotarex Atherectomy Systems include:
Use a kink resistant, suitably reinforced sheath of the same size as the Rotarex™ Atherectomy Catheter, or 1 French size bigger. When choosing a contralateral approach this may also serve to facilitate a smooth transition across the aortic bifurcation.
Do not use the device across a vessel bifurcation or curve that results in a curvature of the catheter shaft of