Severity
Critical
CriticalClass ITerminated
FDA Devices recall · Reported February 26, 2020
NC TREK Coronary Dilatation Catheter, REF 1012455-120 Rx Only,NC TREK RX 5.00 X 20MM 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 implan
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Abbott Vascular recalled NC TREK Coronary Dilatation Catheter, REF 1012455-120 Rx Only,NC TREK RX 5.00 X 20MM BDC … — a critical-severity action.
NC TREK Coronary Dilatation Catheter, REF 1012455-120 Rx Only,NC TREK RX 5.00 X 20MM BDC … was recalled by Abbott Vascular in February 26, 2020. Reason: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.. Check the official notice for the remedy. Verify recall #Z-1139-2020 with the FDA Devices before acting.
The recall
Abbott Vascular issued this critical-severity FDA Devices recall — Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon..
- Critical
- severity level
- Class I
- classification
- February 26, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1139-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1139-2020) was formally reported on February 26, 2020, with the manufacturer initiating the action on January 29, 2020. It is classified under Critical severity (Class I), with a current status of Terminated. Abbott Vascular is listed as the recalling firm, operating out of Temecula, CA. Federal records list the affected scope as Total 39687 NC TREK units (13891 US and 25796 OUS).
The documented reason for this recall is: Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon. Distribution data in the federal record shows the product reached: Worldwide Distribution: US (Nation-wide) and OUS (countries of): Algeria Jordan Argentina Korea Armenia Kuwait Aruba Lebanon Australi…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices — clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category — 40,409 medical devices recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger — we do not rank products by risk from raw recall volume.
Affected scope
Total 39687 NC TREK units (13891 US and 25796 OUS)
Related Recalls
6
6 from same agency
Product description
NC TREK Coronary Dilatation Catheter, REF 1012455-120 Rx Only,NC TREK RX 5.00 X 20MM 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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | Z-1139-2020 |
| Date reported | February 26, 2020 |
| Date initiated | January 29, 2020 |
| Recalling firm | Abbott Vascular |
| Firm location | Temecula, CA |
| Affected scope | Total 39687 NC TREK units (13891 US and 25796 OUS) |
| Distribution | Worldwide Distribution: US (Nation-wide) and OUS (countries of): Algeria Jordan Argentina Korea Armenia Kuwait Aruba Lebanon Australia … |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1139-2020) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting — recall details can be updated.
- This is a Class I (high-risk) recall — stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
NC TREK Coronary Dilatation Catheter, REF 1012455-120 Rx Only,NC TREK RX 5.00 X 20MM 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). Recalled by Abbott Vascular. Units affected: Total 39687 NC TREK units (13891 US and 25796 OUS).
Why was this product recalled? ▼
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 26, 2020. Severity: Critical. Recall number: Z-1139-2020.
Where was the recalled product distributed? ▼
Distribution: 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.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1139-2020) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported February 26, 2020.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of June 2026.