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Euphora™ EUP32520XRecalls & reported problems

Medtronic, Inc. · BALLOON EUP32520X EUPHORA RX US · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
2

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169560239), received between Apr 1, 2019 and Apr 1, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Burst Container or Vessel” (1 report).

2 FDA recall records name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K143480); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Sep 3, 2019Open, Classified

    Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties.

    Z-0122-2020 · Root cause: Under Investigation by firm · FDA record ↗

  2. Jul 13, 2017Terminated

    Stylette removal difficulties on the Euphora and Solarice products.

    Z-3136-2017 · Root cause: Process design · FDA record ↗

Most reported problems

Device problems

  • Burst Container or Vessel1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 1, 2019Burst Container or Vessel; Burst Container or Vessel

    DURING THE PROCEDURE AN ATTEMPT WAS MADE TO USE ONE EUPHORA RX PTCA BALLOON CATHETERS TO TREAT A LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT A BALLOON BURST/LEAK OCCURRED DURING INFLATION. THE BALLOON WAS INFLATED TO A LITTLE ABOVE NOMINAL PRESSURE. NO PATIENT INJURY WAS REPORTED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8468822 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K143480. One submission often covers many models, so check the product and lot details in each record.

  • Z-3137-2017 · Jul 13, 2017 · Terminated
    Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.

Other Catheters, transluminal coronary angioplasty, percutaneous devices

All Catheters, transluminal coronary angioplasty, percutaneous devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.