NC TREKRecalls & reported problems across all models
Abbott Vascular Inc. · 56 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,842
- Deaths reported
- 10
- Injuries reported
- 194
- Recalls
- 12
We found 56 models of NC TREK by Abbott Vascular Inc. in the FDA's device registry (GUDID). Together they are named in 1,842 adverse event reports in the FDA's MAUDE database, received between Dec 7, 2015 and Sep 30, 2026 — classified as 10 deaths, 194 injuries, 1,637 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (660 reports).
12 FDA recall records name at least one of these models by its device identifier.
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
NC TREK recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jan 29, 2020Terminated
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Z-1139-2020 · Root cause: Process change control · Recall details · FDA record ↗
- Jan 29, 2020Terminated
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Z-1138-2020 · Root cause: Process change control · Recall details · FDA record ↗
- Jan 29, 2020Terminated
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Z-1137-2020 · Root cause: Process change control · Recall details · FDA record ↗
- Jan 29, 2020Terminated
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Z-1136-2020 · Root cause: Process change control · Recall details · FDA record ↗
- Jan 29, 2020Terminated
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Z-1135-2020 · Root cause: Process change control · Recall details · FDA record ↗
- Jan 29, 2020Terminated
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Z-1134-2020 · Root cause: Process change control · Recall details · FDA record ↗
- Jan 29, 2020Terminated
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Z-1133-2020 · Root cause: Process change control · Recall details · FDA record ↗
- Jan 29, 2020Terminated
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Z-1132-2020 · Root cause: Process change control · Recall details · FDA record ↗
- Jan 29, 2020Terminated
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Z-1131-2020 · Root cause: Process change control · Recall details · FDA record ↗
- Jan 29, 2020Terminated
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Z-1130-2020 · Root cause: Process change control · Recall details · FDA record ↗
- Jan 29, 2020Terminated
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Z-1129-2020 · Root cause: Process change control · Recall details · FDA record ↗
- Jan 29, 2020Terminated
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Z-1128-2020 · Root cause: Process change control · Recall details · FDA record ↗
Most reported NC TREK problems
Device problems
- Difficult to Remove660
- Material Rupture574
- Material Separation418
- Improper or Incorrect Procedure or Method330
- Deflation Problem230
- Difficult to Advance230
- Inflation Problem143
- Failure to Advance136
Patient problems
- No Consequences Or Impact To Patient848
- No Clinical Signs, Symptoms or Conditions714
- No Patient Involvement177
- Insufficient Information18
- Foreign Body In Patient17
- Obstruction/Occlusion10
- Intimal Dissection9
- Low Blood Pressure/ Hypotension9
NC TREK models
56 models, most reported first. Each model has its own page with its reports, recalls and device details.
- NC TREK 1012454-08Catheters, transluminal coronary angioplasty, percutaneous2 recalls59 reports
- NC TREK 1012453-12Catheters, transluminal coronary angioplasty, percutaneous1 recall84 reports
- NC TREK 1012453-15Catheters, transluminal coronary angioplasty, percutaneous1 recall1 death83 reports
- NC TREK 1012451-15Catheters, transluminal coronary angioplasty, percutaneous114 reports
- NC TREK 1012451-12Catheters, transluminal coronary angioplasty, percutaneous108 reports
- NC TREK 1012455-12Catheters, transluminal coronary angioplasty, percutaneous1 recall2 deaths57 reports
- NC TREK 1012455-08Catheters, transluminal coronary angioplasty, percutaneous1 recall55 reports
- NC TREK™ 1012454-15Catheters, transluminal coronary angioplasty, percutaneous1 recall53 reports
- NC TREK 1012449-12Catheters, transluminal coronary angioplasty, percutaneous96 reports
- NC TREK 1012447-12Catheters, transluminal coronary angioplasty, percutaneous93 reports
- NC TREK 1012453-08Catheters, transluminal coronary angioplasty, percutaneous1 recall42 reports
- NC TREK 1012449-15Catheters, transluminal coronary angioplasty, percutaneous87 reports
- NC TREK™ 1012455-15Catheters, transluminal coronary angioplasty, percutaneous1 recall1 death31 reports
- NC TREK 1012447-15Catheters, transluminal coronary angioplasty, percutaneous80 reports
- NC TREK™ 1012454-20Catheters, transluminal coronary angioplasty, percutaneous1 recall2 deaths30 reports
- NC TREK 1012454-12Catheters, transluminal coronary angioplasty, percutaneous72 reports
- NC TREK 1012453-20Catheters, transluminal coronary angioplasty, percutaneous1 recall1 death20 reports
- NC TREK™ 1012455-20Catheters, transluminal coronary angioplasty, percutaneous1 recall1 death19 reports
- NC TREK 1012448-12Catheters, transluminal coronary angioplasty, percutaneous52 reports
- NC TREK 1012451-08Catheters, transluminal coronary angioplasty, percutaneous46 reports
- NC TREK 1012449-20Catheters, transluminal coronary angioplasty, percutaneous1 death42 reports
- NC TREK 1012448-15Catheters, transluminal coronary angioplasty, percutaneous41 reports
- NC TREK 1012450-15Catheters, transluminal coronary angioplasty, percutaneous39 reports
- NC TREK 1012451-20Catheters, transluminal coronary angioplasty, percutaneous1 death39 reports
- NC TREK 1012449-08Catheters, transluminal coronary angioplasty, percutaneous36 reports
- NC TREK 1012450-12Catheters, transluminal coronary angioplasty, percutaneous34 reports
- NC TREK 1012452-12Catheters, transluminal coronary angioplasty, percutaneous31 reports
- NC TREK 1012452-15Catheters, transluminal coronary angioplasty, percutaneous30 reports
- NC TREK 1012447-08Catheters, transluminal coronary angioplasty, percutaneous29 reports
- NC TREK 1012445-12Catheters, transluminal coronary angioplasty, percutaneous27 reports
- NC TREK™ 1012452-08Catheters, transluminal coronary angioplasty, percutaneous26 reports
- NC TREK™ 1012446-12Catheters, transluminal coronary angioplasty, percutaneous22 reports
- NC TREK 1012448-08Catheters, transluminal coronary angioplasty, percutaneous21 reports
- NC TREK 1012445-15Catheters, transluminal coronary angioplasty, percutaneous20 reports
- NC TREK 1012445-08Catheters, transluminal coronary angioplasty, percutaneous18 reports
- NC TREK 1012447-20Catheters, transluminal coronary angioplasty, percutaneous17 reports
- NC TREK 1012448-20Catheters, transluminal coronary angioplasty, percutaneous16 reports
- NC TREK 1012452-20Catheters, transluminal coronary angioplasty, percutaneous13 reports
- NC TREK™ 1012450-08Catheters, transluminal coronary angioplasty, percutaneous12 reports
- NC TREK™ 1012446-15Catheters, transluminal coronary angioplasty, percutaneous8 reports
- NC TREK 1012450-20Catheters, transluminal coronary angioplasty, percutaneous8 reports
- NC TREK™ 1012446-08Catheters, transluminal coronary angioplasty, percutaneous4 reports
- NC TREK 1012449-25Catheters, transluminal coronary angioplasty, percutaneous4 reports
- NC TREK 1012451-06Catheters, transluminal coronary angioplasty, percutaneous4 reports
- NC TREK 1012444-08Catheters, transluminal coronary angioplasty, percutaneous3 reports
- NC TREK 1012445-20Catheters, transluminal coronary angioplasty, percutaneous3 reports
- NC TREK 1012451-25Catheters, transluminal coronary angioplasty, percutaneous3 reports
- NC TREK 1012443-20Catheters, transluminal coronary angioplasty, percutaneous2 reports
- NC TREK 1012447-06Catheters, transluminal coronary angioplasty, percutaneous2 reports
- NC TREK 1012433-20Catheters, transluminal coronary angioplasty, percutaneous1 report
- NC TREK 1012441-12Catheters, transluminal coronary angioplasty, percutaneous1 report
- NC TREK 1012443-12Catheters, transluminal coronary angioplasty, percutaneous1 report
- NC TREK™ 1012446-20Catheters, transluminal coronary angioplasty, percutaneous1 report
- NC TREK 1012447-25Catheters, transluminal coronary angioplasty, percutaneous1 report
- NC TREK 1012448-06Catheters, transluminal coronary angioplasty, percutaneous1 report
- NC TREK 1012449-06Catheters, transluminal coronary angioplasty, percutaneous1 report
Recent NC TREK adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Difficult to Remove; Material Separation; Difficult to Advance
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948651 ↗MalfunctionSep 29, 2026Failure to Fold; Difficult to Remove
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50935776 ↗InjuryJun 3, 2026Entrapment of Device; Failure to Fold; Failure to Deflate
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LEFT CORONARY ARTERY LESION WITH 70% STENOSIS. THE 5X8 MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND USED FOR POST-DILATION OF A STENT. THE BDC WAS INFLATED TWICE AT 8 ATM AND 10 ATM. THE BALLOON WAS UNABLE TO BE FULLY DEFLATED DESPITE HOLDING 12 TO 14 SECONDS OF NEGATIVE PRESSURE. DURING REMOVAL, THERE WAS A POOR REWRAP OF THE BALLOON AND THE BDC WAS UNABLE TO BE WITHDRAWN THROUGH THE GUIDING CATHETER. A NEEDLE WAS USED TO PUNCTURE THE BALLOON TO FACILITATE REMOVAL. THERE WERE NO ADVERSE PATIENT EFFECTS 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 25377234 ↗MalfunctionJun 1, 2026Material Rupture
IT WAS REPORTED THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED AND TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. THE 3.50X15MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION TO POST DILATE A STENT HOWEVER WHEN INFLATING TO 10 ATMOSPHERES, A LEAK WAS NOTED AT THE PROXIMAL PORTION OF THE BALLOON. THE BDC WAS REMOVED AND ANOTHER ONE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25348764 ↗MalfunctionMay 12, 2026Failure to Fold; Difficult to Remove; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT MAIN ARTERY. FOR POST-DILATATION, THE 4X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS INFLATED FOUR TIMES TO 18-22 ATMOSPHERES (ATM); HOWEVER, THE BDC WAS ATTEMPTED TO BE REMOVED; HOWEVER, THE BDC WAS NOT ABLE TO BE RETRACTED INTO THE GUIDE CATHETER (GC), AND THE DISTAL PORTION OF THE BALLOON WAS NOTED TO HAVE FAILED TO REFOLD. THE BDC WAS ABLE TO BE FORCIBLY PULLED OUT OF THE PATIENT. OTHER UNSPECIFIED DEVICES WERE USED TO CONTINUE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25153070 ↗MalfunctionApr 29, 2026Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method
THE PATIENT PRESENTED WITH PERSISTENT RESIDUAL STENOSIS IN THE PROXIMAL AND MID SEGMENTS OF THE RIGHT CORONARY ARTERY AFTER STENT IMPLANTATION. THE PROCEDURE PERFORMED WAS TO TREAT THE RIGHT CORONARY ARTERY. THE 4.50X12MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS NOTED NOT TO BE PREPPED OUTSIDE THE ANATOMY PRIOR TO USE. THE BDC WAS ADVANCED AND THE BALLOON WAS INFLATED ONCE TO 16 ATMOSPHERES; HOWEVER, AFTER MULTIPLE ATTEMPTS THE BALLOON ONLY PARTIALLY DEFLATED. THE NC TREK BDC WAS SLOWLY WITHDRAWN, AND THE BALLOON WAS STUCK AT THE TIP OF THE GUIDING CATHETER. ALL DEVICES WERE REMOVED AS A SINGLE UNIT AND THE PROCEDURE WAS ABORTED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25034950 ↗MalfunctionApr 22, 2026Deflation Problem; Difficult to Remove; Material Separation
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LATERAL ANTERIOR DESCENDING ARTERY LESION WITH 80% STENOSIS. THE 3.5X15 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS PREPARED WITHOUT ISSUE. THE BDC WAS ADVANCED TO THE TARGET LESION FOR PRE-DILATION; HOWEVER, AFTER THE FIRST INFLATION AT 12 ATM, THE BALLOON WAS NOT ABLE TO BE FULLY DEFLATE. THE BALLOON GOT STUCK AT THE TIP OF THE GUIDING CATHETER AND WAS UNABLE TO BE REMOVED FROM THE BODY. DURING THE RETRACTION PROCESS, THE PROXIMAL SHAFT SEPARATED. EVENTUALLY, THE BALLOON WAS DEFLATED, AND ALL DEVICE SEGMENTS WERE WITHDRAWN INDEPENDENTLY. THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS 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 24956275 ↗InjuryApr 14, 2026Deflation Problem; Difficult to Remove; Improper or Incorrect Procedure or Method; Device Damaged by Another Device
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH NO CALCIFICATION, NO TORTUOSITY AND 90% STENOSIS. THE 4.5X8 MM NC TREK BALLOON DILATATION CATHETER WAS INFLATED ONCE TO 12 ATMOSPHERES AND ALTHOUGH NEGATIVE PRESSURE WAS HELD FOR 16 SECONDS, THE DEVICE WAS NOT FULLY DEFLATED. THERE WAS RESISTANCE BETWEEN DEVICES DURING REMOVAL AND ALL THE DEVICES WERE REMOVED AS A UNIT WITH THE BALLOON STILL PARTIALLY INFLATED. THIS CAUSED THE STENT TO BE DRAGGED OUT. AN UNSPECIFIED BALLOON WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT EXPERIENCED CHEST PAIN AND MYOCARDIAL TEAR INJURY. LOCAL DRUG TREATMENT WAS PROVIDED AND THE PATIENT WAS HOSPITALIZED ADDITIONAL TIME. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Angina; Unspecified Tissue Injury
MAUDE report 24874694 ↗MalfunctionApr 11, 2026Break; Deformation Due to Compressive Stress
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS LEFT CIRCUMFLEX LESION WITH 75% STENOSIS. A 2.75X15 MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS PREPARED BEFORE PATIENT USE. THE BDC WAS ADVANCED TO THE TARGET LESION FOR PRE-DILATION; HOWEVER, THE BDC WAS BENDING. A NEW NC TREK RX WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. ANALYSIS OF THE RETURNED DEVICE INDICATED THAT THE SUPPORT SKIVE/WIRE/BAYONET WAS SEPARATED 6 CM DISTAL TO THE OUTER MEMBER TO HYPOTUBE SEAL, HOWEVER, WAS HELD BY THE OUTER MEMBER. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24846466 ↗MalfunctionMar 18, 2026Deflation Problem; Difficult to Remove
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT CORONARY ARTERY LESION. A 5 X12 MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS PREPARED BEFORE PATIENT USE; HOWEVER, IT WAS DIFFICULT TO REMOVE THE PROTECTIVE SHEATH. THE BDC WAS ADVANCED TO THE TARGET LESION FOR PRE-DILATION WITHOUT ISSUE. HOWEVER, THE BDC WAS UNABLE TO BE FULLY DEFLATED AND WAS UNABLE TO BE RETRACTED BACK INTO THE GUIDING CATHETER. THE SHEATH AND THE ENTIRE DELIVERY SYSTEM WERE REMOVED FROM THE PATIENT AS A WHOLE. THERE WERE NO ADVERSE PATIENT EFFECTS 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 24631765 ↗MalfunctionFeb 20, 2026Material Rupture
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN 88% STENOSED LESION IN THE LEFT CIRCUMFLEX (LCX) ARTERY WITH MODERATE CALCIFICATION AND MILD TORTUOSITY. THE 3.5X20MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND THE BALLOON WAS INFLATED; HOWEVER, A BALLOON LEAKAGE WAS NOTED DURING INFLATION (RUPTURE). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT AND ANOTHER NC TREK BDC WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24403036 ↗MalfunctionFeb 17, 2026Material Rupture; Difficult to Advance
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MID LEFT CIRCUMFLEX CORONARY ARTERY WITH MODERATE CALCIFICATION, MODERATE TORTUOSITY AND 88% STENOSIS. THE 4.0X15 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE LESION AND RESISTANCE WITH THE ANATOMY WAS NOTED. THE BALLOON WAS INFLATED ONCE TO NOMINAL PRESSURE AND A RUPTURE WAS NOTED DUE TO THE ANATOMY. ANOTHER NC TREK BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS 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 24369252 ↗MalfunctionFeb 11, 2026Difficult to Remove; Material Separation; Difficult to Advance
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. DURING USE OF THE 3.0X12 MM NC TREK BALLOON DILATATION CATHETER (BDC), THERE WAS RESISTANCE DURING ADVANCEMENT AND REMOVAL WITH THE GUIDING CATHETER. THE SHAFT SEPARATED IN TWO PIECES INSIDE THE GUIDING CATHETER SO THE GUIDING CATHETER WAS REMOVED. A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS 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 24318775 ↗MalfunctionFeb 11, 2026Material Separation; Failure to Advance
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY CALCIFIED LEFT ANTERIOR DESCENDING LESION WITH 80% STENOSIS. THE 3.50X15MM NC TREK RX BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION FOR PRE-DILATION; HOWEVER, RESISTANCE WAS FELT DURING ADVANCEMENT AND THE PROXIMAL SHAFT SEPARATED. THE REMAINING PART WAS REMOVED MANUALLY WITHOUT ISSUE. AN ADDITIONAL NC TREK RX BDC WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS 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 24315268 ↗MalfunctionFeb 9, 2026Leak/Splash
IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY WITH 90% STENOSIS. A DRUG ELUTING STENT WAS IMPLANTED AND THE 3.5X12 MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS BACKLOADED ONO THE GUIDE WIRE THROUGH THE GUIDING CATHETER WHEN BLOOD WAS NOTED INSIDE THE INFLATION DEVICE. A LEAK WAS SUSPECTED IN THE BALLOON/SHAFT SO THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS 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 24292169 ↗
Other Abbott Vascular Inc. products
- MITRACLIP8 models · 5,973 reports · 2 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
- XIENCE ALPINE72 models · 898 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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