Admiral™ Xtreme ADM060250130LRecalls & reported problems
Medtronic, Inc. · CATH ADM060250130L ADM US 06L250 UL1300 · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08033477064376), received between Jun 3, 2022 and May 11, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (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 18, 2026.
Most reported problems
Device problems
- Burst Container or Vessel2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 11, 2023Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO USE A ADMIRAL EXTREME TO TREAT A LESION IN THE MID SUPERFICIAL FEMORAL ARTERY. DEGREE OF TORTUOSITY WAS NONE. DEGREE OF CALCIFICATION WAS NONE. EMBOLIC PROTECTION WAS NOT USED. A 50/50 CONTRAST/HEP SALINE INFLATION FLUID WAS USED. BALLOON INFLATED ONLY ONCE WITH AN INFLATION DEVICE. DEVICE PREPPED PER THE IFU. THE DEVICE PASSED THROUGH A PREVIOUSLY-DEPLOYED STENT. NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THERE WAS BALLOON BURST DURING INFLATION. THE BALLOON DID NOT FRAGMENT. THE BALLOON WAS REMOVED, WITH NO COMPLICATIONS. NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16911197 ↗MalfunctionJun 3, 2022Burst Container or Vessel; Burst Container or Vessel
PHYSICIAN WAS ATTEMPTING TO USE AN ADMIRAL XTREME PTA DURING PROCEDURE TO TREAT A LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). NO EMBOLIC PROTECTION WAS USED. THERE WAS NO DAMAGE NOTED TO PACKAGING. THE DEVICE WAS PREPPED PER IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED THAT DURING BALLOON INFLATION, BURST/LEAK/RUPTURE OCCURRED AT 8ATM. EVERYTHING CAME OUT TOGETHER DURING REMOVAL. A NEW BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL TREATMENT OR INTERVENTION. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14587611 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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