Abbott Vascular: Medical Device Recall in 2020 - (Recall #: Z-1128-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

NC TREK Coronary Dilatation Catheter, REF 1012453-08 Rx Only, NC TREK RX 4.00 X 8MM 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)

Product Classification:

Class I

Date Initiated: January 29, 2020

Date Posted: February 26, 2020

Recall Number: Z-1128-2020

Event ID: 84826

Reason for Recall:

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

Status: Terminated

Product Quantity: Total 39687 NC TREK units (13891 US and 25796 OUS)

Code Information:

Device Identifier/GTIN:08717648152054 Part Number: 1012453-08 Lot Numbers: 90731G1 90921G1 90808G1 90928G1 90826G1 91003G1 90906G1 91017G1 91106G1

Distribution Pattern:

Worldwide Distribution: US (Nation-wide) and OUS (countries of): Algeria Jordan Argentina Korea Armenia Kuwait Aruba Lebanon Australia Malaysia Austria, Mauritius Bahrain Mexico Bangladesh Morocco Belgium Netherlands Brazil New Zealand Brunei Norway Bulgaria Oman Canada Pakistan Chile Panama China Peru Colombia Poland Costa Rica Portugal Croatia R¿union Cyprus Romania Czech Republic Russian Federation Denmark Saudi Arabia Dominican Republic Singapore Egypt Slovakia Estonia Slovenia Finland South Africa France Spain Germany Sri Lanka Greece State of Palestine Hong Kong Sweden Hungary Switzerland Iceland Taiwan, Province of China India Thailand Indonesia Tunisia Iran Turkey Iraq Ukraine Ireland United Arab Emirates Israel United Kingdom Italy Uruguay Japan Viet Nam

Voluntary or Mandated:

Voluntary: Firm initiated