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Euphora™ EUP22510XRecalls & reported problems

Medtronic, Inc. · BALLOON EUP22510X 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 00643169559943), received between Jun 27, 2022 and Jun 27, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Deflation Problem” (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

  • Deflation 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.

  • MalfunctionJun 27, 2022Deflation Problem; Deflation Problem

    ONE EUPHORA BALLOON CATHETER WAS ATTEMPTED TO BE USED DURING A PROCEDURE TO TREAT THE RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. IT WAS REPORTED THAT BALLOON DEFLATION DIFFICULTIES WERE ENCOUNTERED AND THE BALLOON WOULD NOT DEFLATE AT THE LESION SITE. NO PATIENT INJURY REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 14827225 ↗

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.