Euphora™ EUP2510XRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169560000), received between Aug 24, 2018 and Oct 9, 2023 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 9, 2023Burst Container or Vessel; Deflation Problem; Entrapment of Device; Leak/Splash; Difficult to Remove; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Material Deformation; Burst Container or Vessel; Deflation Problem; Entrapment of Device; Leak/Splash; Difficult to Remove; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE EUPHORA RX BALLOON CATHETER TO TREAT A LESION. IT WAS REPORTED THAT A BALLOON BURST, LEAK OR CATHETER LEAK OCCURRED. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17901712 ↗
• MalfunctionJan 10, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AN ATTEMPT WAS MADE TO USE A EUPHORA BALLOON CATHETER TO TREAT A SEVERELY TORTUOUS LESION WITH MILD CALCIUM, LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NO RESISTANCE NOTED DURING DELIVERY OF THE DEVICE. THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. IT WAS REPORTED THAT THE DEVICE LUER WAS CRACKED/DETACHED. THE DETACHMENT OCCURRED DURING WITHDRAWAL OF THE DEVICE, POST INFLATION OF THE DEVICE IN VIVO. NO RESISTANCE WAS NOTED DURING WITHDRAWAL OF THE DEVICE. IT WAS ALSO REPORTED THAT THE DELIVERY SYSTEM WAS DEFORMED AT THE LUER/HUB. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13204707 ↗
• MalfunctionJul 17, 2019Burst Container or Vessel; Burst Container or Vessel

  A EUPHORA RX PTCA BALLOON CATHETER WAS ATTEMPTED TO BE USED TO TREAT A MILDY CALCIFIED, MODERATELY TORTUOUS LESION EXHIBITING 99% STENOSIS IN THE MID PROXIMAL OBTUSE MARGINAL (OM). THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED DURING BALLOON INFLATION. THE BALLOON WAS FIRSTLY INFLATED TO 10ATM FOR 10 SECONDS, THEN TO 12 ATM FOR 9 SECONDS AND IT WAS REPORTED THAT ON THE 3RD INFLATION AT 8 ATM THE BALLOON LOST PRESSURE AT 6 SECONDS. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8797532 ↗
• MalfunctionJul 16, 2019Fluid/Blood Leak; Material Rupture

  BALLOON DILATION CATHETER BEING USED IN HEART TO DILATE BLOOD VESSEL. FIRST INFLATION AT 6 ATM, NO PROBLEM, SECOND INFLATION AT 7 ATM, NO PROBLEM, INFLATION AT 8 ATM REVEALED A LEAK OF DYE FROM THE BALLOON INDICATING A RUPTURE. BALLOON DEFLATED, AND CATHETER REMOVED. SECOND CATHETER REQUIRED TO COMPLETE PROCEDURE. PHYSICIAN INSPECTED THE AREA WHERE THE FAULTY BALLOON FAILED AND DETERMINED NO PART OF THE BALLOON REMAINED IN THE PATIENT. PHYSICAL INSPECTION OF BALLOON DID NOT REVEAL ANY MISSING PARTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8792991 ↗
• MalfunctionAug 24, 2018Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE A EUPHORA BALLOON DILATATION DEVICE TO TREAT A LESION IN A PATIENT. THE LESION WAS A DISTAL PDA WITH 90% OCCLUSION, WITH MINIMAL TORTUOSITY AND MINIMAL CALCIFICATION. NO DAMAGE WAS FOUND WITH THE PACKAGING. THERE WERE NO ISSUES WITH REMOVING THE DEVICE FROM THE HOOP. NEGATIVE PREP WAS PERFORMED. THE EUPHORA CATHETER WAS ATTEMPTED TO BE USED FOR PRE-DILATING THE LESION, BUT IT DID NOT CROSS, SO IT WAS NOT DEPLOYED. THERE WAS NO PREVIOUSLY DEPLOYED STENT. THERE WAS NO RESISTANCE GOING INTO THE BODY. RESISTANCE WAS FOUND WHEN TRYING TO REMOVE THE EUPHORA BALLOON OUT OF THE GUIDE CATHETER. AFTER THE EUPHORA BALLOON WAS REMOVED FROM THE CATHETER, IT WAS FOUND THAT THE BALLOON CATHETER WAS ¿BROKEN¿. IT WAS REPORTED THAT THE CATHETER/DELIVERY SYSTEM BECAME DEFORMED. NO EXCESSIVE FORCE WAS USED DURING DELIVERY. THE PATIENT WAS STABLE DURING AND AFTER THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. NO ABNORMALITIES WERE FOUND WITH THE ANATOMY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7812136 ↗

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.