Euphora™ EUP1515XRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169559844), received between Jun 13, 2017 and Apr 3, 2025 — classified as 1 injury, 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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2025Burst Container or Vessel; Difficult to Remove; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Material Deformation; Burst Container or Vessel; Difficult to Remove; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE EUPHORA CORONARY BALLOON CATHETER, A BALLOON BURST OCCURRED DURING BALLOON INFLATION. THE BALLOON CAME APART INSIDE THE VESSEL. THE LESION BEING TREATED HAD 90% STENOSIS IN THE MID RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED PRIOR TO USE AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. A GUIDE AND TWO NON-MEDTRONIC WIRES WERE BEING USED ALSO IN THE VESSEL. IT WAS DETAILED THAT THE BALLOON WAS INFLATED TO 12 ATM AND THEN DEFLATED. THE BALLOON WAS FURTHER INFLATED TO 12, 12, 18, 18, AND THEN 19 ATM. THEN, ON THE NEXT INFLATION THE BALLOON WOULD NOT INFLATE AND THERE WAS NO BLOOD BACK AT THE HUB. A YELLOW PIECE OF BALLOON HAD COME OFF THE BALLOON IN THE PATIENT. A 2.0 MM BALLOON WAS INSERTED AND PARTIALLY INFLATED AND REMOVED THE EUPHORA DEVICE THAT HAD COME APART. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Device Embedded In Tissue or Plaque; Insufficient Information

  MAUDE report 21762195 ↗
• MalfunctionJul 20, 2023Burst Container or Vessel; Leak/Splash; Burst Container or Vessel; Leak/Splash

  AN ATTEMPT WAS MADE TO USE ONE EUPHORA RX BALLOON CATHETER TO TREAT A CALCIFIED LESION IN THE PROXIMAL MARGINAL ARTERY. IT WAS REPORTED THAT DURING INFLATION THE BALLOON RUPTURED BEFORE NOMINAL PRESSURE WAS REACHED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17366883 ↗
• InjuryJun 13, 2017Difficult to Remove; Difficult to Remove

  THE PHYSICIAN INTENDED TO USE A EUPHORIA RX BALLOON TO TREAT A TIGHT CALCIFIED LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WHICH WAS REPORTED TO BE MILDLY CALCIFIED BUT NOT TORTUOUS WITH 85% STENOSIS. NO DAMAGE WAS NOTED TO PACKAGING AND NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE TRAY/HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES IDENTIFIED. NEGATIVE PREP WAS ALSO PERFORMED WITH NO ISSUES. IT WAS REPORTED THAT THE BALLOON WAS BEING USED TO HELP THE NON-MDT BRAND WIRE CROSS THE LESION. THE GUIDEWIRE WAS EXAMINED AND FLUSHED BEFORE USE WITH NO ISSUES NOTED. NO ISSUES NOTED LOADING THE BALLOON ON THE GUIDEWIRE. RESISTANCE WAS NOTED WHEN TRYING TO MOVE THE BALLOON ALONG THE NON-MDT WIRE. THE BALLOON THEN GOT STUCK ON THE WIRE DURING DELIVERY OF THE GUIDEWIRE TO / ACROSS THE LESION SITE. DISSECTION WAS NOTED BUT IT IS UNCONFIRMED IF THIS WAS DUE TO THE BALLOON OR NOT. THE LESION WAS STENTED AND THE PATIENT IS REPORTED TO BE 'FINE'. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY-DEPLOYED STENT AND EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. DIFFICULTIES WERE REPORTED WHILE ATTEMPTING TO REMOVE THE BALLOON AND THE BALLOON COULD NOT BE REMOVED BY ITSELF. THE

  Patient problems: Vascular Dissection

  MAUDE report 6636011 ↗

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.