Euphora™ EUP2020XRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169559905), received between Oct 19, 2020 and Mar 11, 2026 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Deflation Problem” (3 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. 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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2026Burst Container or Vessel; Improper or Incorrect Procedure or Method; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE EUPHORA RX CORONARY BALLOON CATHETER, THE BALLOON BURST DURING BALLOON INFLATION. THE TARGET LESION EXHIBITED SEVERE TORTUOSITY, SEVERE CALCIFICATION AND 99% LESION STENOSIS. THE BALLOON RUPTURED DURING INFLATION WHILE ATTEMPTING TO PREPARE THE LESION FOR A LARGER BALLOON TO CROSS. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24570620 ↗
• MalfunctionMay 13, 2024Deflation Problem; Deflation Problem

  DURING A PROCEDURE AN ATTEMPT WAS MADE TO USE ONE EUPHORA RX BALLOON CATHETER (LOT 227945950) TO TREAT A LESION. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. IT WAS REPORTED THAT BALLOON DEFLATION DIFFICULTIES OCCURRED AND THAT THE DEVICE WAS SLOW TO DEFLATE AT THE LESION SITE. THE BALLOON WAS REMOVED FROM THE PATIENT STILL ON THE WIRE. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY. DURING THE SAME PROCEDURE IT WAS INTENDED TO USE ONE EUPHORA RX BALLOON CATHETER (LOT 227220474) TO TREAT A LESION. THERE WAS NO DAMAGE NOTED TO THE PACKAGING OF THE DEVICE. THE DEVICE WAS INSPECTED WITH ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. IT WAS REPORTED THE CATHETER/DELIVERY SYSTEM WAS DEFORMED AT THE TIP AND A KINK WAS NOTED. THE TIP DEFORMATION WAS NOTED ON DEVICE INSPECTION, OUT OF THE BOX. THE DEVICE WAS NOT USED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19297431 ↗
• InjuryAug 18, 2023Burst Container or Vessel; Leak/Splash; Difficult to Remove; Detachment of Device or Device Component; Burst Container or Vessel; Leak/Splash; Difficult to Remove; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE ONE EUPHORA RX PTCA BALLOON CATHETER TO TREAT A MILDLY TORTUOUS, SEVERELY CALCIFIED LESION WITH 90% STENOSIS IN THE PROXIMAL/MID/DISTAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS NOT PRE-DILATED. 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 A BALLOON BURST, LEAK OR CATHETER LEAK OCCURRED DURING BALLOON INFLATION AT 7ATM FOR 20SECONDS. SIX INFLATIONS WERE APPLIED TO THE DEVICE PRIOR TO THE ISSUE OCCURRING. IT WAS NOTED THAT THE BALLOON POPPED WHEN TRYING TO PASS AND INFLATE IN THE HEAVILY CALCIFIED LESION. IT WAS DETAILED THAT THERE WAS DIFFICULTY REMOVING AND RETRIEVING THE BALLOON FRAGMENT. A FEMORAL APPROACH WAS USED TO STENT THE RCA. THE PATIENT WAS OK AFTER THE PROCEDURE AND WENT HOME. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17577713 ↗
• MalfunctionDec 29, 2021Deflation Problem; Deflation Problem

  AN ATTEMPT WAS MADE TO US A EUPHORA RX BALLOON TO TREAT A LESION. IT WAS REPORTED THAT BALLOON DEFLATION DIFFICULTIES WERE ENCOUNTERED. THE BALLOON WOULD NOT DEFLATE AT THE LESION SITE. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13108043 ↗
• MalfunctionApr 15, 2021Deflation Problem; Deflation Problem

  DURING A PROCEDURE, AN ATTEMPT WAS MADE TO USE ONE EUPHORA RX PTCA BALLOON CATHETER TO TREAT A LESION LOCATED IN THE OBTUSE MARGINAL. THE DEVICE WAS NOT INSPECTED. THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT BALLOON DEFLATION DIFFICULTIES OCCURRED AND THE DEVICE WOULD NOT DEFLATE AT THE LESION SITE. IT WAS STATED THAT THE WOULD NOT DEFLATE AFTER IT WAS INFLATED TO 14 ATM FOR 25 SECONDS. THE BALLOON WAS SUCCESSFULLY PULLED OUT FROM THE ARTERY AND REMOVED WHILE STILL INFLATED. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11670033 ↗
• InjuryOct 19, 2020Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  ONE EUPHORA RX BALLOON CATHETER WAS ATTEMPTED TO BE USED TO TREAT A TORTUOUS LESION. IT WAS STATED THAT THE DEVICE WAS ORIGINALLY USED AS A RAIL TO GET THE GUIDE UP THE CORONARY TREE THROUGH THE RADIAL ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. THE BALLOON WAS INFLATED TO 1-2 ATMS TO HELP GET THE GUIDE UP. IT WAS REPORTED THAT THE BALLOON APPEARED TO SEPARATE. THE PHYSICIAN TOOK ANOTHER BALLOON AND WAS ABLE TO TRAP THE MATERIAL AND TAKE IT OUT THROUGH THE GUIDE WHILE WEDGED IN A LAUNCHER GUIDE CATHETER. IT WAS ALSO REPORTED THAT DIFFICULTIES WERE NOTED WHEN REMOVING THE BALLOON FOLLOWING INFLATION. NO FURTHER PATIENT INJURY REPORTED.

  Patient problems: Injury; Insufficient Information

  MAUDE report 10695781 ↗

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.