Catheter, Peripheral, Atherectomy

Rotarex Atherectomy System and Instructions for Use, BD SET Rotarex:

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.

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.

Turbo Elite Laser Atherectomy Catheter

Due to complaints received for the marker band detaching from the distal tip of the catheter and remaining in the patient as laser catheter was retracted.

Spectranetics Turbo-Elite Laser Atherectomy Catheter 2.0 RX REF 420-159

Incorrect product labeling. Exterior product box label does not match internal pouch label.

Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral vasculature.

The device has similarities in design to another device that the firm recently issued a field correction on due to instances of tip detachment and embolization.

Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature.

The device has similarities in design to another device that the firm recently issued a field correction on due to instances of tip detachment and embolization.

Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT., Multi-vessel, 6F (2.2 mm) Recommended sheath, 0.014" (0.36 mm) Compatible

Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.

Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1-S-INT, Small Vessel, 6F (2.2 mm) Recommended sheath, 0.014" (0.36 mm) Compatible g

Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.

Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchange Catheters

Potential for flouroscopially visible marker band at the tip of the Rapid Exchange Turbo Elite Atherectomy Catheters to become loose or disengaged rom the catheter when the device is in use in an off-label manner.

ViperWire Advance with Flextip Peripheral Atherectomy Guide Wire, Part Number: 7-10026-01,Model Number: VPR-GW-FT14.

CSI is recalling three lots of VIPERWIRE ADVANCE WITH FLEXTIP PERIPHERAL ATHERECTOMY GUIDEWIRE . It was discovered that 0.018in ViperWire Advance with Flextip product was packaged as a 0.014in ViperWire Advance with Flextip.