VascuTrak® V184040Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741061530), received between Oct 18, 2019 and Dec 16, 2020 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2020Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE, THE DEVICE WAS ALLEGEDLY UNABLE TO LOAD ONTO THE GUIDEWIRE. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11017294 ↗
• MalfunctionNov 20, 2020Material Rupture; Detachment of Device or Device Component; Material Rupture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF CALCIFIED TARGET LESION IN THE SUPERFICIAL FEMORAL ARTERY VIA IPSILATERAL APPROACH, THE PTA BALLOON ALLEGEDLY RUPTURED AT 6ATM. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10873407 ↗
• MalfunctionOct 13, 2020Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE OF CALCIFIED LESION IN THE COMMON FEMORAL ARTERY AND SUPERFICIAL FEMORAL ARTERY VIA CONTRALATERAL APPROACH, RESISTANCE WAS FELT DURING ADVANCING THE CATHETER, AND CONTRAST MEDIUM LEAKAGE WAS FOUND DURING INFLATION. THEN RUPTURE WAS FOUND AFTER REMOVING THE CATHETER AND ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10673657 ↗
• MalfunctionJul 18, 2020Material Rupture; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL V184040 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED MATERIAL RUPTURE. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. THE (B)(6) MALE PATIENT WAS (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10293432 ↗
• MalfunctionJan 15, 2020Break; Material Rupture; Break; Material Rupture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL V184040 VASCUTRAK PTA DILATATION CATHETER ALLEGEDLY EXPERIENCED BALLOON LONGITUDINAL MATERIAL RUPTURE AND BREAK. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. OF THE ONE BALLOON LONGITUDINAL MATERIAL RUPTURE MALFUNCTION, ONE PATIENT WAS INVOLVED WITH NO PATIENT CONSEQUENCE OR IMPACT. PATIENT'S AGE, WEIGHT, AND GENDER WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9594168 ↗
• MalfunctionOct 18, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL V184040 PTA BALLOON DILATATION CATHETER ALLEGEDLY EXPERIENCED A BREAK AND DETACHMENT OF DEVICE OR DEVICE COMPONENT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED AND THERE WAS NO REPORTED PATIENT INJURY. PATIENT INFORMATION WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9211273 ↗