DeviceClearance

Recall Z-1129-2020— Abbott Vascular

Class I · Terminated

Class I FDA medical device recall by Abbott Vascular, initiated 2020-01-29, terminated 2024-04-16. It names 2 FDA 510(k) clearances: K110134, K103153. Product: NC TREK Coronary Dilatation Catheter, REF 1012453-12 Rx Only, NC TREK RX 4.00 X 12MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only). Reason: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon..

Recalling firm
Abbott Vascular
Classification
Class I
Status
Terminated
Initiated
2020-01-29
Terminated
2024-04-16
Firm location
Temecula, CA, United States

510(k) clearances named in this recall

2 on FDA's record

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

NC TREK Coronary Dilatation Catheter, REF 1012453-12 Rx Only, NC TREK RX 4.00 X 12MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only)

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.