Highlander H41502H15Recalls & reported problems
Bard Peripheral Vascular, Inc. · Highlander 014 PTA Balloon Dilatation Catheter 2.5mm x 150mm, 150cm Catheter · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741213458), received between Jun 10, 2024 and May 12, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Material Rupture” (2 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Rupture2
- Deflation Problem1
- Device Contaminated at the User Facility1
- Device Contamination with Chemical or Other Material1
- Difficult to Advance1
- Failure to Advance1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 12, 2025Material Rupture; Material Rupture
ON (B)(6) 2025, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE HIGHLANDER 014 BALLOON CATHETER. DURING THE PROCEDURE, THE BALLOON WAS ALLEGEDLY RUPTURED AT 15 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22000955 ↗MalfunctionDec 29, 2024Leak/Splash; Material Rupture; Difficult to Advance; Leak/Splash; Material Rupture; Difficult to Advance
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN THE SEVERELY CALCIFIED BELOW KNEE SUPERFICIAL FEMORAL ARTERY VIA THE CONTRALATERAL APPROACH, THE PTA BALLOON ALLEGEDLY RUPTURED AT 10 ATM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21032683 ↗MalfunctionNov 11, 2024Deflation Problem; Failure to Advance; Deflation Problem; Failure to Advance
IT WAS REPORTED THAT DURING AN ANGIOPLASTY PROCEDURE IN ANTERIOR TIBIAL ARTERY VIA IPSILATERAL APPROACH, THE PTA BALLOON WAS ALLEGEDLY NOT PASSING THROUGH THE STENOSIS. IT WAS FURTHER REPORTED THAT THERE IS AN ISSUE IN DEFLATING THE DEVICE DURING A PREVIOUS INFLATION. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20649621 ↗MalfunctionJun 10, 2024Device Contamination with Chemical or Other Material; Device Contaminated at the User Facility; Device Contamination with Chemical or Other Material; Device Contaminated at the User Facility
IT WAS REPORTED THAT PRIOR TO AN ANGIOPLASTY PROCEDURE, THE PHYSICIAN ACCIDENTALLY DROPPED THE CATHETER AND MADE IT UNCLEAN. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19495860 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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