NC Trek RX Coronary Dilatation Catheter
Medical device recall Z-2037-2017. Published in FDA’s Enforcement Report on May 24, 2017.
- FDA Class I
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on May 24, 2017. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Terminated its status, in FDA’s file
- Not named no state, in where it went
- 449,661 units total (132,040 units in US) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the balloon.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
NC Trek RX Coronary Dilatation Catheter, Part No. 1012448-06, 1012448-08, 1012448-12, 1012448-15, 1012448-20, 1012449-06, 1012449-08, 1012449-12, 1012449-15, 1012449-20, 1012449-25, 1012450-06, 1012450-08, 1012450-12, 1012450-15, 1012450-20, 1012451-06, 1012451-08, 1012451-12, 1012451-15, 1012451-20, 1012451-25, 1012452-08, 1012452-12, 1012452-15, 1012452-20, 1012453-08, 1012453-12, 1012453-15, 1012453-20
449,661 units total (132,040 units in US), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Lot Number 60414G1 60721G1 60208G1 60419G1 60420G1 60603G1 60906G1 61121G1 61121G2 60225G1 60229G1 60318G1 60318G2 60429G1 60429G2 60607G1 60705G1 60804G1 60818G1 60921G1 60921G2 61108G1 61111G1 61128G1 61128G2 61218G1 60202G1 60310G1…
Every code shown here, 1,995 characters
Lot Number 60414G1 60721G1 60208G1 60419G1 60420G1 60603G1 60906G1 61121G1 61121G2 60225G1 60229G1 60318G1 60318G2 60429G1 60429G2 60607G1 60705G1 60804G1 60818G1 60921G1 60921G2 61108G1 61111G1 61128G1 61128G2 61218G1 60202G1 60310G1 60401G1 60408G1 60408G2 60510G1 60616G1 60721G1 60809G1 60912G1 61014G1 61028G1 61206G1 61206G2 60310G1 60421G1 60421G2 60527G1 60716G1 60819G1 61024G2 60523G1 61026G1 60317G1 60318G1 60412G1 60419G1 60502G1 60502G2 60525G1 60705G1 60801G1 60809G1 60826G1 60916G1 61018G1 61121G1 61121G2 60218G1 60303G1 60330G1 60330G2 60406G1 60406G2 60406G3 60406G4 60408G1 60413G1 60413G2 60425G1 60429G1 60511G1 60512G1 60531G1 60607G1 60623G1 60713G1 60721G1 60804G1 60805G1 60809G1 60812G1 60816G1 60824G1 60926G1 60929G1 61012G1 61019G1 61019G2 61020G1 61115G1 61121G1 61122G1 61123G1 61123G2 61201G1 61208G1 61214G1 61214G2 61216G1 61216G2 60128G1 60215G1 60215G2 60224G1 60322G1 60329G1 60330G1 60330G2 60330G3 60401G1 60407G1 60407G2 60427G1 60428G1 60428G2 60428G3 60429G1 60502G1 60603G1 60609G1 60621G1 60718G1 60720G1 60727G1 60801G1 60809G1 60810G1 60816G1 60824G1 60906G1 60919G1 60926G1 60928G1 61104G1 61107G1 61111G1 61111G3 61122G1 61123G1 61128G1 61130G1 61202G1 60126G1 60223G1 60225G1 60226G1 60323G1 60331G1 60331G2 60516G1 60519G1 60721G1 60805G1 60824G1 60907G1 61004G1 61116G1 61128G1 61130G1 61206G1 60405G1 60412G1 60805G1 60610G1 61101G1 60530G1 60803G1 61014G1 61206G1 60212G1 60412G1 60414G1 60528G1 60623G1 60831G1 60921G1 61104G1 61207G1 61209G1 60315G1 60317G1 60328G1 60414G1 60414G2 60613G1 60718G1 60810G1 60901G1 60922G1 61128G1 61130G1 60318G1 60329G1 60429G1 60613G1 60804G1 60929G1 60603G1 61006G1 60323G1 60329G1 60329G2 60330G1 60425G1 60428G1 60526G1 60531G1 60623G1 60713G1 60805G1 60819G1 60929G1 61104G1 61204G1 61206G1 61207G1 61208G1 60205G1 60214G1 60215G1 60322G1 60330G1 60408G1 60415G2 60415G3 60415G4 60418G1 60418G2 60502G1 60525G2 60527G1 60527G2 60601G1 60616G1 60629G1 60720G1 60729G1 60805G1 60818G1 60829G1 60907G1…
FDA’s list runs to 3,418 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US and Worldwide
These words name no state.
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Mar 22, 2017.
- FDA classified it on May 12, 2017.
- FDA’s Enforcement Report published it on May 24, 2017.
- FDA terminated it on Feb 7, 2018.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Abbott Vascular, of Temecula, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 3,418 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.