Stent, Coronary

Boston Scientific Liberte Monorail and Over-the-Wire Coronary Stent Systems to be relabeled as VeriFLEX".

Boston Scientific initiated a field correction for the Liberte Bare-Metal coronary stent products. They have received reports from cardiac cath labs that TAXUS Liberte Paclitaxel-Eluting (TAXUS Libert Drug-Eluting) coronary stents have been inadvertently selected when the interventional cardiologist intended to implant a Liberte Bare-Metal stent, and Libert Bare-Metal stents have been ina

POWERSAIL Coronary Dilatation Catheter: 3.25x18mm (US)

Distal shaft of the POWERSAIL coronary Dilatation Catheters exhibits damage that may result in a leak of contrast material and functional failures.

POWERSAIL Coronary Dilatation Catheter: 4.0x8mm (CE)

Distal shaft of the POWERSAIL coronary Dilatation Catheters exhibits damage that may result in a leak of contrast material and functional failures.

POWERSAIL Coronary Dilatation Catheter: 2.75x18mm (US)

Distal shaft of the POWERSAIL coronary Dilatation Catheters exhibits damage that may result in a leak of contrast material and functional failures.

POWERSAIL Coronary Dilatation Catheter: 3.25x8mm (US)

Distal shaft of the POWERSAIL coronary Dilatation Catheters exhibits damage that may result in a leak of contrast material and functional failures.

VOYAGER NC Coronary Dilatation Catheter, 4.5 X 8.0 mm.

The recall was initiated after Abbott Vascular received reports the protective, yellow balloon sheath of the 4.5mm diameter VOYAGER NC Coronary Dilatation Catheter has been tight. If unnoticed by the user, there is a potential to cause damage to the balloon dilatation catheter during removal of the sheath. The balloon sheath covers the balloon, maintaining the fold configuration and protects the

Multi-Link Vision RX Coronary Stent System, 3.0 x 15mm, Part number 1007848-15, lot number 7052951

The affected single lot did not meet an internal specification. One unit failed the test criteria for stent dislodgment testing.

Edwards LifeStent NT Self-Expanding Stent and Delivery System;

Potential for deployment difficulties.

Voyager RX Coronary Dilatation Catheter

Leak at guide wire exit notch could introduce air into the artery.

Express 2 Monorail Coronary Stent Systems (bare metal stents) - balloon expandable Express 316L stainless steel Stent premounted on a MONORAIL catheter with a D

Due to characteristics in the delivery catheters that have the potential to impede balloon deflation during a coronary angioplasty procedure.