NC Euphora™ NCEUP2527XRecalls & reported problems
Medtronic, Inc. · BALLOON NCEUP2527X NCEUPHORA RX US · Class 2
All models of NC Euphora (40)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169396135), received between May 22, 2024 and May 22, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).
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
- Burst Container or Vessel1
- Detachment of Device or Device Component1
- Inflation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 22, 2024Burst Container or Vessel; Inflation Problem; Detachment of Device or Device Component; Burst Container or Vessel; Inflation Problem; Detachment of Device or Device Component
AN ATTEMPT WAS MADE TO USE ONE NC EUPHORA RX BALLOON CATHETER TO TREAT A MILDLY TORTUOUS AND MILDLY CALCIFIED LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS NOT PRE-DILATED, THE DEVICE WAS BEING USED TO PRE-DILATE THE LESION. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT INFLATION DIFFICULTIES WERE ENCOUNTERED DURING BALLOON INFLATION AT 12 ATM. IT WAS STATED THAT THE DEVICE DID NOT INFLATE PROPERLY UNDER FLUORO. THERE WAS PARTIAL INFLATION OF THE BALLOON. THE DEVICE WAS REMOVED AND TESTED, WHERE IT WAS NOTICED THAT THE BALLOON WAS INFLATING PROXIMAL TO THE BALLOON PORTION OF THE CATHETER. THE DEVICE WAS NOT MOVED OR REPOSITIONED WHILE INFLATED. THE SAME INFLATION WAS DEVICE SUCCESSFULLY USED WITH OTHER DEVICES. THE PATIENT IS ALIVE WITH NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19369520 ↗
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- Maverick²™ H7493892820200Boston Scientific Corporation · Catheters, transluminal coronary angioplasty, percutaneous161 reports
- NC TREK 1012454-08Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous2 recalls59 reports
- TREK™ 1012272-15Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous2 deaths158 reports
- NC TREK 1012453-12Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous1 recall84 reports
- NC TREK 1012453-15Abbott Vascular Inc. · Catheters, transluminal coronary angioplasty, percutaneous1 recall1 death83 reports
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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