NC TREK NEORecalls & reported problems across all models
Abbott Vascular Inc. · 45 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 520
- Deaths reported
- 2
- Injuries reported
- 10
- Recalls
- 0
We found 45 models of NC TREK NEO by Abbott Vascular Inc. in the FDA's device registry (GUDID). Together they are named in 520 adverse event reports in the FDA's MAUDE database, received between Nov 22, 2022 and Sep 30, 2026 — classified as 2 deaths, 10 injuries, 508 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (432 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported NC TREK NEO problems
Device problems
- Material Rupture432
- Difficult to Advance277
- Difficult to Remove58
- Improper or Incorrect Procedure or Method42
- Material Separation19
- Failure to Advance15
- Leak/Splash12
- Material Split, Cut or Torn9
Patient problems
- No Clinical Signs, Symptoms or Conditions511
- Foreign Body In Patient3
- Perforation of Vessels2
- Vascular Dissection2
- Cardiac Tamponade1
- Device Embedded In Tissue or Plaque1
- Pain1
- Pericardial Effusion1
NC TREK NEO models
45 models, most reported first. Each model has its own page with its reports, recalls and device details.
- NC TREK NEO™ 1400300-12Catheters, transluminal coronary angioplasty, percutaneous41 reports
- NC TREK NEO™ 1400300-15Catheters, transluminal coronary angioplasty, percutaneous35 reports
- NC TREK NEO™ 1400250-12Catheters, transluminal coronary angioplasty, percutaneous33 reports
- NC TREK NEO™ 1400350-12Catheters, transluminal coronary angioplasty, percutaneous29 reports
- NC TREK NEO™ 1400400-08Catheters, transluminal coronary angioplasty, percutaneous29 reports
- NC TREK NEO™ 1400250-15Catheters, transluminal coronary angioplasty, percutaneous27 reports
- NC TREK NEO™ 1400350-15Catheters, transluminal coronary angioplasty, percutaneous26 reports
- NC TREK NEO™ 1400300-08Catheters, transluminal coronary angioplasty, percutaneous25 reports
- NC TREK NEO™ 1400450-08Catheters, transluminal coronary angioplasty, percutaneous21 reports
- NC TREK NEO™ 1400200-12Catheters, transluminal coronary angioplasty, percutaneous20 reports
- NC TREK NEO™ 1400350-08Catheters, transluminal coronary angioplasty, percutaneous20 reports
- NC TREK NEO™ 1400275-12Catheters, transluminal coronary angioplasty, percutaneous18 reports
- NC TREK NEO™ 1400325-12Catheters, transluminal coronary angioplasty, percutaneous16 reports
- NC TREK NEO™ 1400275-15Catheters, transluminal coronary angioplasty, percutaneous15 reports
- NC TREK NEO™ 1400500-08Catheters, transluminal coronary angioplasty, percutaneous13 reports
- NC TREK NEO™ 1400275-08Catheters, transluminal coronary angioplasty, percutaneous11 reports
- NC TREK NEO™ 1400200-15Catheters, transluminal coronary angioplasty, percutaneous10 reports
- NC TREK NEO™ 1400350-20Catheters, transluminal coronary angioplasty, percutaneous9 reports
- NC TREK NEO™ 1400400-12Catheters, transluminal coronary angioplasty, percutaneous9 reports
- NC TREK NEO™ 1400400-15Catheters, transluminal coronary angioplasty, percutaneous9 reports
- NC TREK NEO™ 1400225-12Catheters, transluminal coronary angioplasty, percutaneous8 reports
- NC TREK NEO™ 1400250-08Catheters, transluminal coronary angioplasty, percutaneous1 death8 reports
- NC TREK NEO™ 1400225-15Catheters, transluminal coronary angioplasty, percutaneous7 reports
- NC TREK NEO™ 1400300-20Catheters, transluminal coronary angioplasty, percutaneous1 death7 reports
- NC TREK NEO™ 1400450-12Catheters, transluminal coronary angioplasty, percutaneous7 reports
- NC TREK NEO™ 1400375-08Catheters, transluminal coronary angioplasty, percutaneous6 reports
- NC TREK NEO™ 1400500-12Catheters, transluminal coronary angioplasty, percutaneous6 reports
- NC TREK NEO™ 1400325-08Catheters, transluminal coronary angioplasty, percutaneous5 reports
- NC TREK NEO™ 1400325-15Catheters, transluminal coronary angioplasty, percutaneous5 reports
- NC TREK NEO™ 1400350-06Catheters, transluminal coronary angioplasty, percutaneous5 reports
- NC TREK NEO™ 1400375-12Catheters, transluminal coronary angioplasty, percutaneous5 reports
- NC TREK NEO™ 1400200-08Catheters, transluminal coronary angioplasty, percutaneous4 reports
- NC TREK NEO™ 1400250-20Catheters, transluminal coronary angioplasty, percutaneous4 reports
- NC TREK NEO™ 1400300-06Catheters, transluminal coronary angioplasty, percutaneous4 reports
- NC TREK NEO™ 1400375-15Catheters, transluminal coronary angioplasty, percutaneous4 reports
- NC TREK NEO™ 1400600-12Catheters, transluminal coronary angioplasty, percutaneous4 reports
- NC TREK NEO™ 1400550-12Catheters, transluminal coronary angioplasty, percutaneous3 reports
- NC TREK NEO™ 1400225-08Catheters, transluminal coronary angioplasty, percutaneous2 reports
- NC TREK NEO™ 1400250-06Catheters, transluminal coronary angioplasty, percutaneous2 reports
- NC TREK NEO™ 1400250-25Catheters, transluminal coronary angioplasty, percutaneous2 reports
- NC TREK NEO™ 1400400-20Catheters, transluminal coronary angioplasty, percutaneous2 reports
- NC TREK NEO™ 1400275-20Catheters, transluminal coronary angioplasty, percutaneous1 report
- NC TREK NEO™ 1400375-20Catheters, transluminal coronary angioplasty, percutaneous1 report
- NC TREK NEO™ 1400450-15Catheters, transluminal coronary angioplasty, percutaneous1 report
- NC TREK NEO™ 1400500-20Catheters, transluminal coronary angioplasty, percutaneous1 report
Recent NC TREK NEO adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Material Rupture; Difficult to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50953275 ↗MalfunctionSep 30, 2026Material Rupture; Difficult to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949537 ↗MalfunctionSep 30, 2026Material Rupture; Difficult to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949205 ↗MalfunctionSep 30, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949068 ↗MalfunctionSep 30, 2026Material Rupture; Difficult to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949067 ↗MalfunctionSep 29, 2026Material Rupture
It was reported that the procedure was to treat the left circumflex coronary artery with heavy calcification, moderate tortuosity and 90% stenosis. The 2.75x8 mm NC Trek Neo balloon dilatation catheter (BDC) was inflated 4 times to 12 atmospheres and ruptured. Another device was used to complete the procedure. There were no adverse patient effects. No additional information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935001 ↗MalfunctionSep 25, 2026Material Rupture; Difficult to Advance
It was reported that the procedure was to treat a dde novo lesion in the proximal right coronary artery (pRCA) with 75% stenosis, moderate calcification and moderate tortuosity. The 3.5.x15mm NC TREK Neo balloon was advanced with resistance at the target lesion for predilation; however, the balloon ruptured during the initial inflation at 6 atm. The device was removed and the procedure continued using a non-Abbott balloon. There was no adverse patient effect and there was no clinically significant delay in the procedure. No additional information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50900132 ↗MalfunctionSep 25, 2026Material Rupture; Difficult to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50899759 ↗MalfunctionSep 24, 2026Material Rupture; Difficult to Advance
It was reported that the procedure was performed to treat a moderately calcified, moderately tortuous lesion in the left anterior descending artery with a 2.25x15mm NC TREK NEO RX balloon catheter. Reportedly, resistance was encountered against the lesion when advancing the balloon. Upon initial inflation, the balloon ruptured at 6 atmospheres. The procedure was continued using another balloon. There were no adverse patient effects. No additional information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50885884 ↗MalfunctionSep 21, 2026Material Rupture; Difficult to Advance
It was reported that the procedure was to treat the right coronary artery (RCA) with moderate calcification, mild tortuosity and 90% stenosis after stent implantation. The 3x8 mm NC Trek Neo was used for post-dilatation and there was resistance noted during advancement. The balloon ruptured during the first inflation at 10 atmospheres. A non-Abbott balloon was used to complete the procedure. There were no adverse patient effects. No additional information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50843107 ↗MalfunctionSep 17, 2026Off-Label Use; Material Rupture; Improper or Incorrect Procedure or Method
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50809973 ↗MalfunctionSep 17, 2026Material Rupture; Difficult to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50809227 ↗MalfunctionJun 4, 2026Material Rupture; Difficult to Advance
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE DISTAL RIGHT CORONARY ARTERY (RCA) WITH HEAVY CALCIFICATION, MODERATE TORTUOSITY AND 90% STENOSIS. THE 6X12 MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION AND RESISTANCE WAS NOTED WITH THE ANATOMY. THE BALLOON WAS INFLATED ONCE TO 6 ATMOSPHERES AND RUPTURED. THERE WERE NO ADVERSE PATIENT EFFECTS. ANOTHER NC TREK NEO BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25398481 ↗MalfunctionJun 2, 2026Material Rupture; Difficult to Advance
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MODERATE CALCIFICATION, MILD TORTUOSITY AND 90% STENOSIS. THE 2.5X12 MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION AND RESISTANCE WAS NOTED WITH THE ANATOMY. THE BALLOON RUPTURED DURING THE FIRST INFLATION TO 12 ATMOSPHERES. ANOTHER TREK BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25363795 ↗MalfunctionMay 29, 2026Material Rupture; Difficult to Advance
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MODERATE CALCIFICATION, MILD TORTUOSITY AND 90% STENOSIS. THE 2.0X15 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION AND RESISTANCE WAS NOTED WITH THE PREVIOUSLY IMPLANTED STENT [ANATOMY]. THE BALLOON WAS INFLATED ONCE TO 12 ATMOSPHERES AND RUPTURED. ANOTHER NC TREK BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25334588 ↗
Other Abbott Vascular Inc. products
- MITRACLIP8 models · 5,973 reports · 2 recalls
- NC TREK56 models · 1,842 reports · 12 recalls
- Armada213 models · 1,904 reports
- Indeflator7 models · 1,196 reports · 9 recalls
- XIENCE Sierra56 models · 1,161 reports · 1 recall
- XIENCE Skypoint69 models · 1,142 reports
- Graftmaster15 models · 1,071 reports
- TREK50 models · 909 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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