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
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-1130-2020
- 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 1012453-15 Rx Only, NC TREK RX 4.00 X 15MM 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
Questions about this recall
Why was it recalled?
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Which lots are affected?
Device Identifier/GTIN: 08717648152078 Part Number: 1012453-15 Lot Numbers: 90815G1 91008G1 90816G1 91009G1 90828G1 91020G1 90904G1 91026G1 90920G1 91109G1 90926G1 91117G1
Where was it sold?
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
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
16 other products · FDA event 84826This product is part of a recall event; the main page for the event is NC Traveler Coronary Dilatation Catheter recalled by Abbott Vascular.
More recalls from Abbott Vascular
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|---|---|---|---|---|---|
| Device | CLASS II | 20/30 Priority Pack Kit/.115 RHV recalled by Abbott Vascular | Abbott Vascular | Packaging Defects | 40 states |
| Device | CLASS II | 20/30 Indeflator, REF: 1000184, for use during cardiovascular recalled | Abbott Vascular | Packaging Defects | 40 states |
| Device | CLASS II | 20/30 Priority Pack Accessory Kit/.096 RHV recalled by Abbott Vascular | Abbott Vascular | Packaging Defects | 40 states |
| Device | CLASS II | 20/30 Priority Pack Accessory Kit w/Copilot recalled by Abbott Vascular | Abbott Vascular | Packaging Defects | 40 states |
| Device | CLASS II | Product/Part: MitraClip G4 CDS NT Repair-mr recalled by Abbott Vascular | Abbott Vascular | Device Malfunction | Nationwide |
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| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |