Euphora™ EUP3010XRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169560130), received between Apr 5, 2017 and Aug 11, 2017 — classified as 3 malfunctions.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · FDA record ↗

2. Jul 13, 2017Terminated

   Stylette removal difficulties on the Euphora and Solarice products.

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

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2017Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO USE TWO EUPHORA RX BALLOONS. NO DAMAGE WAS NOTED TO THE DEVICE PACKAGING AND NO ISSUES WERE NOTED WHEN REMOVING THE DEVICES FROM THE HOOP/TRAY. THE DEVICES WERE INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. IT WAS REPORTED THAT ISSUES WERE ENCOUNTERED WHEN TRYING TO REMOVE THE STYLET ON BOTH DEVICES. THE DEVICES WERE FLUSHED IN THE HOOP/PLACED IN A BOWL OF SALINE TO ACTIVATE THE HYDROPHILIC COATING. THE PHYSICIAN DID SAY HE HAD DIFFICULTY REMOVING THE STYLET BUT WAS ABLE TO DO SO AND THE STYLET ISSUE HAD NO IMPACT ON THE PATIENT AS HE WAS ABLE TO DILATE. THE PHYSICIAN WANTED TO USE THE 2ND BALLOON TO DILATE THE LESION AGAIN BUT THE STYLET COULD NOT BE REMOVED. AFTER INITIAL RESISTANCE WAS ENCOUNTERED WHEN REMOVING THE SHEATH/ STYLETTE THE PHYSICIAN PULLED HARDER AND RIPPED HIS GLOVE, THIS OCCURRED WITH THE 2ND BALLOON.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6787770 ↗
• MalfunctionAug 11, 2017Deflation Problem; Deflation Problem

  THE PHYSICIAN INTENDED TO USE A EUPHORA BALLOON CATHETER TO TREAT A TORTUOUS LAD WITH 90% STENOSIS. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES. NO DIFFICULTIES WERE NOTED WHEN REMOVING THE PROTECTIVE SHEATH FROM THE DEVICE. NO DIFFICULTIES WERE RECALLED BY THE ACCOUNT WHEN PREPARING THE DEVICE. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. NO DIFFICULTIES NOTED DURING THE INFLATION OF THE DEVICE. DURING THE PROCEDURE, BALLOON DEFLATION DIFFICULTIES OCCURRED AND THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE. A NON-MDT INFLATION DEVICE WAS USED AND IT WAS REPLACED WITH A NEW NON-MDT INFLATION DEVICE. HOWEVER, THIS DID NOT WORK. IT IS REPORTED THAT THE PHYSICIAN PULLED THE BALLOON BACK INTO THE GUIDE CATHETER AND TOOK THE ENTIRE SYSTEM OUT AFTER SEVERAL ATTEMPTS TO DEFLATE BALLOON. DEFLATION DIFFICULTIES WERE NOTED AFTER THE FIRST INFLATION. THE DEVICE WAS NOT MOVED OR REPOSITIONED PRIOR TO THE DEFLATION DIFFICULTIES. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6787435 ↗
• MalfunctionApr 5, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PATIENT HAD STENTS PREVIOUSLY IMPLANTED. AN EUPHORA BALLOON DILATION CATHETER WAS BEING USED TO TREAT THE RCA. THE LESION WAS MODERATELY TORTUOUS WITH 90% STENOSIS. THERE WAS NO DAMAGE TO THE PACKAGING AND NO ISSUES REMOVED THE DEVICE FROM THE HOOP/TRAY. DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS NOT PRE-DILATED. DEVICE PASSED THROUGH A PREVIOUS DEPLOYED STENT. RESISTANCE WAS EXPERIENCED WHEN ADVANCING THE DEVICE BUT IT IS UNKNOWN IT EXCESSIVE FORCE WAS USED. BALLOON WASN'T INFLATED. IT IS REPORTED THAT DURING ADVANCEMENT OF THE DEVICE A BREAK/FRACTURE OCCURRED ON THE MID SHAFT OF THE CATHETER. ALL PARTS OF THE DEVICE WERE SUCCESSFULLY REMOVED. THE DETACHED PORTION WAS PULLED OUT BY THE SHAFT. THE DEVICE WAS NOT KINKED AND RESTRAIGHTENED DURING USE. THERE IS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6459639 ↗

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.