Abbott Vascular

Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.

Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.

Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.

Inflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air embolism.

An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been observed. Contributing causes may be clip locking component material properties and certain use conditions. Unsuccessful clip procedure can lead to recurrence of severe mitral regurgitation, device embolization, or tissue injury.

An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been observed. Contributing causes may be clip locking component material properties and certain use conditions. Unsuccessful clip procedure can lead to recurrence of severe mitral regurgitation, device embolization, or tissue injury.

An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been observed. Contributing causes may be clip locking component material properties and certain use conditions. Unsuccessful clip procedure can lead to recurrence of severe mitral regurgitation, device embolization, or tissue injury.

There is a potential that the proximal marker may separate from the imaging catheter

Due to an increase in complaint trend for leaks and intermittent/loose connections.

Due to an increase in complaint trend for leaks and intermittent/loose connections.

Due to an increase in complaint trend for leaks and intermittent/loose connections.

Due to an increase in complaint trend for leaks and intermittent/loose connections.

Due to an increase in complaint trend for leaks and intermittent/loose connections.

Incorrect expiration date

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

Reports of implantable mitral valve repair system clips unexpectedly opening and becoming nonfunctional, resulting from unintended excessive force applied during the Clip implantation. Excessive force can also result in unexpected movement of clip arms. The inability to close and remove the device has lead to surgery and additional intervention.

Incorrect expiration being entered for one lot.

Abbott Vascular is initiating a recall of the Absorb Bioresorbable Vascular Scaffold (BVS) System due to studies showing elevated rates of major adverse events, specifically, myocardial infraction and scaffold thrombosis when compared to patients treated with the Xience metallic drug eluting stent.

Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the balloon.

Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the balloon.

Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the balloon.

Abbott Vascular is recalling the StarClose SE Vascular Closure System because it may exhibit difficulty or failure to deploy the StarClose SE Clip.

Abbott Vascular has recently received reports of cases on Clip Delivery System devices that contain the One-Way Actuator Knob where a user attempted implanting a MitraClip, but the Clip could not be detached from the delivery system due to a mandrel fracture.

Abbott Vascular has initiated a recall of the HT Connect Peripheral Guide Wires due to a small number of devices exhibiting partial delamination of the PTFE coating.

The recall was initiated because Abbot Vascular has discovered that the identified lots of the RX Accunet Embolic Protection System may exhibit difficult removal of the peel away sheath due to higher than normal wall thickness.

Abbott Vascular is recalling the Armada 35 and Armada 35 LL PTA Catheters because they have discovered that some devices may exhibit difficulty inflating and/or deflating.