CLASS I Device recall · Reported 26 Feb 2020 · FDA Enforcement Report

NC TREK Coronary Dilatation Catheter recalled by Abbott Vascular

Abbott Vascular is recalling NC TREK Coronary Dilatation Catheter, distributed nationwide in the US. The recall was initiated on 29 Jan 2020 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesDevice Identifier/GTIN: 08717648152061 Part Number: 1012453-12 Lot Numbers: 90730G1 90919G1 90731G1 90927G1 90818G1 91001G1 90822G1 91015G1 90905G1 91025G1 90918G1 91101G1

Quantity recalledTotal 39687 NC TREK units (13891 US and 25796 OUS)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1129-2020
FDA event ID: 84826
Recalling firm: Abbott Vascular, Temecula, CA
Classification: Class I
Status: Terminated
Recall initiated: 29 Jan 2020
FDA classified: 14 Feb 2020
Reported: 26 Feb 2020
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

29 Jan 2020	Recall initiated by company
14 Feb 2020	Classified by FDA	+16 days
26 Feb 2020	Published in enforcement report	+12 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

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)

Where it was distributed

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

Nationwide

Questions about this recall

Is NC TREK Coronary Dilatation Catheter recalled?

Yes. Abbott Vascular recalled NC TREK Coronary Dilatation Catheter on 29 Jan 2020. The recall is Class I and its status is Terminated. Recall number Z-1129-2020.

Why was it recalled?

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

Which lots are affected?

Device Identifier/GTIN: 08717648152061 Part Number: 1012453-12 Lot Numbers: 90730G1 90919G1 90731G1 90927G1 90818G1 91001G1 90822G1 91015G1 90905G1 91025G1 90918G1 91101G1

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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