Abbott Vascular NC TREK Coronary Dilatation Catheter, REF 1012455-12 Rx Only, NC TREK RX recall — FDA Z-1137-2020
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Overview of recall records associated with Abbott Vascular, including dates, categories and classifications where available.
Classification mix: Class I: 23, Class II: 13.
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.…
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…
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…
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…
This page summarizes recall records in which the official source identifies Abbott Vascular as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.