NC TREK NEO™ 1400350-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 08717648232619), received between Mar 18, 2023 and May 20, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (18 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2026Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. A 3.5X8 MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION ALONG A HT BMW UNIVERSAL II 190 CM GUIDE WIRE FOR PRE-DILATION. HOWEVER, RESISTANCE WAS NOTED DURING ADVANCEMENT AND REMOVAL OF THE BDC ALONG THE GUIDEWIRE. THE DEVICES WERE STILL USED FOR PRE-DILATION AND 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 25232120 ↗
• MalfunctionJan 8, 2026Material Rupture; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AND TORTUOUS LESION IN THE RIGHT CORONARY ARTERY. THE 3.50X8MM RX NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE NOTED DUE TO THE ANATOMY. DURING THE SECOND INFLATION AT 8 ATMOSPHERES, THE BALLOON RUPTURE OCCURRED. THE BDC WAS REMOVED AND ANOTHER BALLOON 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 24003513 ↗
• MalfunctionSep 10, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, MODERATELY CALCIFIED, MODERATELY TORTUOUS RIGHT CORONARY ARTERY THAT IS 90% STENOSED. DURING ADVANCEMENT OF A 3.50X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC), RESISTANCE WAS NOTED DUE TO ANATOMY. THE NC TREK NEO BALLOON RUPTURED AT 8 ATMOSPHERES DURING THE SECOND INFLATION, THEN REMOVED. A NEW UNSPECIFIED NC TREK BDC 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 23022129 ↗
• MalfunctionMay 22, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE LEFT CIRCUMFLEX (LCX) ARTERY WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. FOR PRE-DILATATION, THE 3.5X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION AND DURING ADVANCEMENT RESISTANCE WAS NOTED. THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE SECOND INFLATION AT 8 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. ANOTHER NC TREK NEO BALLOON 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 22073958 ↗
• MalfunctionMar 19, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. FOR PRE-DILATATION, THE 3.5X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY AND THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED AT 16 ATMOSPHERES (ATM) DURING THE FIRST INFLATION. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. A NON-ABBOTT BALLOON 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 21646164 ↗
• MalfunctionMar 11, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE MID LEFT ANTERIOR DESCENDING (MLAD) WITH HEAVY CALCIFICATION AND MODERATE TORTUOSITY. THE 3.5X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED WITH RESISTANCE DUE TO ANATOMY TO THE TARGET LESION. THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT AND A NON-ABBOTT BALLOON 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 21574448 ↗
• MalfunctionFeb 12, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 99% STENOSED DE NOVO LESION IN THE RIGHT CORONARY ARTERY (RCA) WITH MODERATE CALCIFICATION AND MODERATE TORTUOSITY. THE 3.5X8MM NC TREK BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY AND THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED DURING THE SECOND INFLATION AT 8 ATMOSPHERES (ATM). THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. ANOTHER NC TREK BALLOON 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 21370056 ↗
• MalfunctionJan 2, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY WITH HEAVY CALCIFICATION, MODERATE TORTUOSITY AND 99% STENOSIS. THE 3.5X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WHICH WAS PREPPED PER THE IFU, WAS ADVANCED WITH RESISTANCE FROM THE ANATOMY. THE BALLOON WAS INFLATED TWICE, ON THE SECOND INFLATION A RUPTURE OCCURRED AT 8 ATMOSPHERES. ANOTHER NC TREK BDC WAS USED TO CONTINUE 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 21058744 ↗
• MalfunctionAug 28, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE CARDIAC ABLATION PROCEDURE WAS TO TREAT A LESION IN THE MID RIGHT CORONARY ARTERY (MRCA) WITH 90% STENOSIS, HEAVY CALCIFICATION AND MODERATE TORTUOSITY. A 3.25X15MM XIENCE SKYPOINT STENT WAS IMPLANTED. THE 3.5X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) HAD RESISTANCE DURING ADVANCEMENT WITH THE LESION AND WAS USED FOR POST DILATATION PER STANDARD PROCEDURE WHEN THE BALLOON RUPTURED DURING THE FIRST INFLATION AT 6 ATMOSPHERES (ATMS). ANOTHER SAME SIZE NON-ABBOTT BALLOON WAS USED TO PERFORM ADDITIONAL DILATION SEVERAL TIMES AND THE PROCEDURE WAS COMPLETED. 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 20088040 ↗
• MalfunctionAug 27, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED DE NOVO LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING (PLAD) WITH MODERATE CALCIFICATION. FOR POST DILATATION, 3.5X8MM NC TREK NEO BALLOON DILATATION CATHETER WAS ADVANCED TO THE TARGET LESION WITH RESISTANCE DUE TO THE ANATOMY. AT THE TARGET LESION THE BALLOON WAS INFLATED; HOWEVER, THE BALLOON RUPTURED AT 4 ATMOSPHERES (ATM) DURING THE FIRST INFLATION. THEREFORE, THE BDC WAS REMOVED FROM THE PATIENT. ANOTHER 3.5X8MM NC TREK NEO BALLOON 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 20080036 ↗
• MalfunctionAug 6, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A CHRONIC TOTAL OCCLUSION (CTO) IN THE HEAVILY CALCIFIED, HEAVILY TORTUOUS AND 99% STENOSED LEFT ANTERIOR DESCENDING CORONARY ARTERY. ORBITAL ATHERECTOMY SYSTEM (OAS) WAS USED TO TREAT THE CTO. THEN THE 3.5X8MM NC TREK NEO BALLOON DILATATION CATHETER, WHICH WAS PREPPED PER INSTRUCTIONS FOR USE, WAS ADVANCED WITH RESISTANCE NOTED DUE TO THE ANATOMY. THE BALLOON WAS INFLATED ONCE TO 8 ATMOSPHERES WHEN A RUPTURE OCCURRED. A NON-ABBOTT BALLOON WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19924604 ↗
• MalfunctionJul 23, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT CIRCUMFLEX ARTERY WITH HEAVY CALCIFICATION, MODERATE TORTUOSITY AND 90% STENOSIS. THE 3.5×8 NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED AND RESISTANCE WITH THE ANATOMY WAS NOTED. THE DEVICE WAS USED FOR PLAIN OLD BALLOON ANGIOPLASTY (POBA), BUT THE BALLOON RUPTURED AT 17 ATMOSPHERES AFTER TWO INFLATIONS DUE TO THE CALCIFICATION. AFTER ROTABLATION WAS PERFORMED, A STENT WAS DEPLOYED, AND THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19807245 ↗
• MalfunctionApr 9, 2024Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance; Material Rupture; Improper or Incorrect Procedure or Method; Difficult to Advance

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. DURING PREPARATION OF THE 3.5X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC), THE BALLOON WAS NOT SOAKED IN SALINE. THE BDC WAS ADVANCED TO THE LESION WITH RESISTANCE NOTED WITH THE CALCIFICATION. THE BALLOON WAS INFLATED ONCE TO 6 ATMOSPHERES HOWEVER A LEAK WAS NOTED AND A BALLOON RUPTURE SUSPECTED. THE BDC WAS REMOVED WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER BDC. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19071463 ↗
• MalfunctionApr 4, 2024Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT WHEN OPENING THE 3.50X8MM NC TREK NEO BALLOON DILATATION CATHETER THE CHIPBOARD BOX WAS NOT OPEN; HOWEVER, ONCE OPEN IT WAS NOTED POUCH INSIDE WAS OPEN AT THE CORNER. A NEW NEO TREK WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19042022 ↗
• MalfunctionJan 10, 2024Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  SUBSEQUENT TO THE INITIALLY FILED MDR REPORT IT WAS REPORTED THE BALLOON WAS INFLATED ONCE TO 6 ATMOSPHERES WHEN A RUPTURE OCCURRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18486495 ↗
• MalfunctionNov 7, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WITH MILD CALCIFICATION, MODERATE TORTUOSITY. THE 3.50X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS BEING USED FOR POST DILATATION; HOWEVER, A RUPTURE OCCURRED AT THE FIRST INFLATION AT 12 ATMOSPHERES. A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18085418 ↗
• MalfunctionOct 30, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE MID RIGHT CORONARY ARTERY THAT WAS HEAVILY CALCIFIED, MODERATELY TORTUOUS AND 75% STENOSED. AFTER ROTABLATION AND PRE-DILATATION, A 3.5X15MM XIENCE SKYPOINT STENT WAS DEPLOYED. A 3.5X8MM NC TREK NEO WAS USED FOR POST-DILATATION, BUT THE BALLOON RUPTURED AT 8 ATMOSPHERES. A NON-ABBOTT STENT WAS USED TO COMPLETE THE POST-DILATATION. THERE WAS NO ADVERSE PATIENT EFFECT. THERE WAS NO REPORT OF CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18035897 ↗
• MalfunctionAug 3, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. THE 3.5X8MM NC TREK BALLOON DILATATION CATHETER (BDC) RUPTURED AT 18 ATMOSPHERES DURING THE FIRST INFLATION. A NON-ABBOTT DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17452285 ↗
• MalfunctionJul 28, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 90% STENOSED LESION IN THE MID RIGHT CORONARY ARTERY WITH HEAVY CALCIFICATION AND MILD TORTUOSITY. FOR PRE-DILATATION THE 3.5X8MM NC TREK NEO BALLOON DILATATION CATHETER (BDC) WAS ADVANCED TO THE TARGET LESION WITH SOME RESISTANCE MET WITH THE LESION. THE BALLOON RUPTURED AT 10 ATMOSPHERES DURING THE FIRST INFLATION. THE BDC WAS REMOVED FROM THE PATIENT AND A NON-ABBOTT BALLOON WAS USE TO COMPLETE THE PROCEDURE. PRIOR TO USE, THE CATHETER WAS SOAKED IN SALINE AND THE BDC WAS PREPPED (AIR ASPIRATION) OUTSIDE ANATOMY. 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 17420624 ↗
• MalfunctionMar 18, 2023Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION LOCATED IN THE MID RIGHT CORONARY ARTERY THAT WAS BOTH MILDLY CALCIFIED AND TORTUOUS AND 90% STENOSED. THE 3.50X8MM NC TREK NEO WAS ADVANCED TO THE LESION WITHOUT ISSUE. DURING THE FIRST INFLATION AT 8 ATMOSPHERES (ATM) FOR 10 SECONDS, THE BALLOON RUPTURED. THE DEVICE WAS REMOVED WITHOUT ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A 3.5X8MM NON-ABBOTT BALLOON DILATATION CATHETER WAS USED TO COMPLETE PRE-DILATATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16570257 ↗