Euphora™ EUP1520XRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169559851), received between Jul 5, 2017 and Nov 8, 2022 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 8, 2022Leak/Splash; Leak/Splash

  AN ATTEMPT WAS MADE TO USE ONE EUPHORA RX BALLOON CATHETER TO TREAT A NON TORTUOUS, SEVERELY CALCIFIED BLOCKAGE IN THE MID RIGHT CORONARY ARTERY (RCA), WITH 95% STENOSIS, THAT NEEDED TO BE OPENED. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHILE DELIVERING THE BALLOON. EXCESSIVE FORCE WAS NOT REQUIRED TO DELIVER THE BALLOON. IT WAS REPORTED THAT THE BALLOON WAS UNABLE TO CROSS THE LESION. BEFORE CROSSING THE LESION THE DEVICE WAS PULLED NEGATIVE AND WHEN THIS WAS DONE THERE WAS BLOOD RETURN. AS THE BALLOON WAS NOT ABLE TO CROSS THE LESION IT WAS REMOVED FROM THE BODY. AT THIS TIME THE BALLOON WAS ATTEMPTED TO BE INFLATED BUT IT DID NOT INFLATE. THE BALLOON WAS FOUND TO HAVE A HOLE IN IT. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15751101 ↗
• MalfunctionMar 21, 2022Burst Container or Vessel; Burst Container or Vessel

  ONE EUPHORA RX BALLOON CATHETER WAS ATTEMPTED TO BE USED TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION WITH CTO (CHRONIC TOTAL OCCLUSION-100%) IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT THE BALLOON BURST DURING INFLATION. 8 ATM OF INFLATION PRESSURE HAD BEE APPLIED TO THE BALLOON. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13838432 ↗
• InjuryMar 23, 2020Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component; Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component

  DURING A PCI PROCEDURE AN ATTEMPT WAS MADE TO USE ONE EUPHORA RX PTCA BALLOON CATHETER TO TREAT A MODERATELY TORTUOUS, SEVERELY CALCIFIED LESION EXHIBITING 99% STENOSIS LOCATED IN THE OSTIUM OF THE CIRCUMFLEX (CX) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE EUPHORA BALLOON WAS ATTEMPTED TO BE USED TO PRE-DILATE THE LESION. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS USED DURING DELIVERY. IT WAS REPORTED THAT THE BALLOON DETACHED FROM THE CATHETER DURING REMOVAL OF THE DEVICE FROM THE PATIENT. IT WAS STATED THAT FIRSTLY AN ATTEMPT WAS MADE TO PRE-DILATE THE LESION WITH A 2.0 DIAMETER BALLOON AND IT FAILED TO CROSS THE LESION. THE EUPHORA RX 1.5 X 20MM BALLOON WAS THEN SELECTED WHICH SUCCESSFULLY CROSSED THE LESION, HOWEVER, ENCOUNTERED GREAT RESISTANCE WHEN TRYING TO DELIVER THE BALLOON ACROSS THE LESION DUE TO THE ANGLE AND CALCIFICATION. IT WAS REPORTED THAT THE BALLOON WAS INFLATED TO 10ATM WHEN IT WAS OBSERVED IT HAD RUPTURED. AN ATTEMPT WAS MADE TO WITHDRAW THE BALLOON BACK INTO THE GUIDE AND SIGNIFICANT RESISTANCE WAS ENCOUNTERED

  Patient problems: Injury

  MAUDE report 9864426 ↗
• InjuryJul 5, 2017Defective Device; Defective Device

  AS REPORTED, THE PHYSICIAN INTENDED TO USE AN EURPHORA RX BALLOON TO TREAT PDA WITH MINIMAL CALCIFICATION, 90% STENOSIS. NO DAMAGE WAS NOTED TO PACKAGING NOR WERE THERE ANY ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE SO NO EXCESSIVE FORCE WAS APPLIED. THERE WAS NO SUDDEN OR GRADUAL DROP IN PRESSURE NOTED ON THE INFLATION DEVICE. THE DEVICE WAS NOT MOVED OR RE-POSITIONED PRIOR TO THE ISSUE. IT WAS REPORTED THAT DURING BALLOON INFLATION AT 14 ATM, DISTAL TO THE BALLOON, THERE WAS A 3MM BUBBLE. STAINING WAS SEEN WHERE THE BUBBLE WAS ON THE BALLOON. THE BALLOON DIDN'T BURST. ON THE SECOND INFLATION IT INFLATED ONLY AT THE DISTAL END AND LOOKED LIKE A GUARDWIRE. DISSECTION OCCURRED. PHYSICIAN FEELS THE DISSECTION WAS CAUSED BY THE BALLOON THE PROCEDURE WAS COMPLETED USING A NON MEDTRONIC DEVICE.

  Patient problems: Vascular Dissection

  MAUDE report 6685536 ↗

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.