Euphora™ EUP3012XRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00643169560147), received between Jun 23, 2017 and Nov 13, 2025 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 13, 2025Deformation Due to Compressive Stress; Detachment of Device or Device Component; Positioning Problem; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Positioning Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING ONE EUPHORA CORONARY BALLOON CATHETER, THE DEVICE DETACHED, CRACKED OR FRACTURED. THE DEVICE WAS PUSHED AND TWISTED IN ORDER TO ADVANCE IT AND NEVER CROSSED THE LESION. THE DEVICE COMPLETELY BROKE AS IT WAS BEING PULLED OUT OF THE PATIENT. THE BREAK OCCURRED AT THE CATHETER. THE DETACHED PORTION WAS EXPOSED AT THE SHEATH AND WAS ABLE TO  BE REMOVED FROM THE BODY.  THE DEVICE WAS INSPECTED PRIOR TO USE AND NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS MODERATELY TORTUOUS AND SEVERELY CALCIFIED LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 99% STENOSIS. THE LESION WAS 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.  THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23541716 ↗
• MalfunctionSep 3, 2025Deformation Due to Compressive Stress; Difficult to Open or Remove Packaging Material; Material Deformation; Material Split, Cut or Torn; Deformation Due to Compressive Stress; Difficult to Open or Remove Packaging Material; Material Deformation; Material Split, Cut or Torn

  IT WAS REPORTED THAT AFTER REMOVAL OF ONE EUPHORA RX CORONARY BALLOON CATHETER FROM THE HOOP, THE STYLET WAS FOUND TO BE MELTED INTO THE BALLOON AND CUT THROUGH THE PHYSICIAN'S GLOVE. THE CATHETER/DELIVERY SYSTEM WAS NOTED TO BE DEFORMED AT THE TIP. THERE WAS NO DAMAGE NOTED TO PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED PRIOR TO USE WITH ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22950717 ↗
• InjuryAug 26, 2024Fracture; Inflation Problem; Difficult to Remove; Detachment of Device or Device Component; Material Deformation; Fracture; Inflation Problem; Difficult to Remove; Detachment of Device or Device Component; Material Deformation

  AN ATTEMPT WAS MADE TO USE ONE EUPHORA CORONARY BALLOON CATHETER TO TREAT A MILDLY TORTUOUS, MILDLY CALCIFIED LESION IN THE MID CIRCUMFLEX (CX) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS PRE-DILATED. THE DEVICE DID 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 INFLATION DIFFICULTIES OCCURRED DURING BALLOON INFLATION. IT WAS ALSO REPORTED THAT THE CATHETER SYSTEM WAS STRETCHED AND DEFORMED, AND THERE WERE DIFFICULTIES REMOVING THE BALLOON FOLLOWING INFLATION. THE BALLOON WOULD NOT INFLATE, AND BLOOD WAS DRAWN BACK DURING PREP OF THE BALLOON WHEN IN PLACE AT THE STENT FOR POST DILATION. THE SHAFT OF THE BALLOON CATHETER WAS FRACTURED AND BROKE, AND ANOTHER BALLOON WAS INSERTED IN ORDER TO REMOVE FRACTURED BALLOON. THE PATIENT IS ALIVE WITH NO FURTHER INJURY.

  Patient problems: Insufficient Information

  MAUDE report 20063965 ↗
• InjurySep 2, 2022Deflation Problem; Deflation Problem

  AN ATTEMPT WAS MADE TO USE ONE EUPHORA RX BALLOON CATHETER TO TREAT A MODERATELY TORTUOUS, MILDLY CALCIFIED LESION WITH 80% STENOSIS IN THE MID 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 NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT DEFLATION DIFFICULTIES OCCURRED AT THE LESION SITE. THE BALLOON DID NOT DEFLATE AFTER 10 ATM FOR 10 SECONDS INFLATION. ANOTHER INFLATION DEVICE WAS USED TO TRY TO DEFLATE THE BALLOON. MANY NEGATIVE PULLS WERE ATTEMPTED ALONG WITH THE OTHER INFLATION DEVICE TO DEFLATE BALLOON, HOWEVER THE BALLOON WAS EVENTUALLY REMOVED WHILE IT WAS STILL INFLATED. NO FURTHER PATIENT INJURY WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 15346877 ↗
• MalfunctionFeb 7, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  AN ATTEMPT WAS MADE TO USE A EUPHORA RX BALLOON TO TREAT A NOT SEVERELY CALCIFIED, MINIMAL VESSEL TORTUOSITY LESION WITH 90% STENOSIS IN THE 1ST DIAGONAL. THERE WAS NO DAMAGE NOTED TO THE DEVICE PACKAGING. THERE WERE NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE PROTECTIVE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES. THE LESION WAS NOT PRE-DILATED. THE SAME INFLATION DEVICE WAS NOT SUCCESSFULLY USED WITH OTHER DEVICES, IT WAS THE FIRST DEVICE USED ON THE LESION. THE BALLOON WAS USED TO PRE DILATE THE LESION. THE DEVICE WAS NOT MOVED OR REPOSITIONED WHILE INFLATED. RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT INFLATIONS DIFFICULTIES WERE EXPERIENCED. IT WAS NOTED THAT THE BALLOON WOULD NOT INFLATE, ATTEMPTED INFLATION RESULTED IN ZERO INFLATION. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13470209 ↗
• MalfunctionDec 14, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  AN ATTEMPT WAS MADE TO USE A EUPHORA RX PTCA BALLOON CATHETER. THERE WAS NO DAMAGE NOTED TO THE PACKAGING. THERE WAS NO DIFFICULTY NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. IT WAS REPORTED THAT THE STYLET WAS STUCK IN THE TIP OF THE DEVICE. THE STYLET AT THE END OF BALLOON HAD RESISTANCE AND WAS UNABLE TO BE REMOVED. FORCE WAS APPLIED CAUSING THE STAFF TO TEAR THE GLOVE. THERE WAS NO HARM CAUSED TO THE STAFF. THE DEVICE WAS NOT ATTEMPTED TO BE LOADED ONTO THE GUIDEWIRE. THE DEVICE WAS NOT USED IN THE PATIENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12998106 ↗
• MalfunctionSep 24, 2020Burst Container or Vessel; Burst Container or Vessel

  ONE EUPHORA BALLOON CATHETER WAS ATTEMPTED TO BE USED. IT WAS REPORTED THAT AFTER THE BALLOON CROSSED THE LESION THE BALLOON RUPTURED AT HIGHER THAN RECOMMENDED INFLATION (22ATM). NO PATIENT INJURY REPORTED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10580403 ↗
• MalfunctionFeb 5, 2019Deflation Problem; Deflation Problem

  AN ATTEMPT WAS MADE TO USE A EUPHORA RX BALLOON CATHETER TO TREAT A LESION IN THE PROXIMAL RAMUS. THE LESION EXHIBITED MILD TORTUOSITY AND MILD CALCIFICATION. NO DIFFICULTIES WERE NOTED WHEN REMOVING THE PROTECTIVE SHEATH OR PACKAGING STYLETTE FROM THE DEVICE. THE DEVICE WAS INSPECTED, AND NEGATIVE PREP WAS PERFORMED PRIOR TO USE WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. DURING THE PROCEDURE A SECOND WIRE WAS USED TO PROTECT THE LAD. THE EUPHORA WAS THEN PASSED TO THE LESION WITH EASE. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT AND RESISTANCE WAS NOT ENCOUNTERED WHEN ADVANCING THE DEVICE. A 50/50 CONCENTRATION OF CONTRAST / SALINE WAS USED. WHEN AN ATTEMPT WAS MADE TO INFLATE THE BALLOON, THE PHYSICIAN COULD NOT SEE THE BALLOON, IT WAS ASSUMED THAT THE EUPHORA DEVICE WAS NOT PREPPED PROPERLY, HOWEVER THE NURSE REPORTED THAT THERE WAS SUFFICIENT CONTRAST AVAILABLE. WHEN AN ATTEMPT WAS MADE TO DEFLATE, IT WAS FELT THAT THE BALLOON WAS STILL INFLATED AS RESISTANCE WAS FELT. DEFLATION DIFFICULTIES NOTED AFTER THE FIRST INFLATION. CONTRAST WAS INJECTED TO SEE THE BALLOON WAS STILL INFLATED. NEGATIVE WAS PULLED ON THE INFLATION DEVICE. A SYRINGE WAS CONNECTED TO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8304065 ↗
• MalfunctionAug 21, 2018Burst Container or Vessel; Burst Container or Vessel

  AN ATTEMPT WAS MADE TO USE A EUPHORA RX PTCA BALLOON CATHETER. IT WAS REPORTED THAT THE DEVICE FAILED TO CROSS THE LESION AND THAT BALLOON RUPTURE OCCURRED AT 13 ATM'S.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7800293 ↗
• MalfunctionJun 23, 2017Burst Container or Vessel; Detachment of Device or Device Component; Burst Container or Vessel; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PHYSICIAN USED A EUPHORA RX BALLOON TO TREAT A LESION IN THE PROXIMAL 1ST OM WITH SEVERE CALCIFICATION AND TORTUOSITY. NO DAMAGE WAS NOTED TO THE DEVICE PACKAGING. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. DURING INFLATION OF THE BALLOON TO PREDILATE A LESION, THE BALLOON RUPTURED. BALLOON WAS INFLATED TWICE PRIOR TO THE RUPTURE AND 16ATM WAS APPLIED. THERE WAS A GRADUAL DROP IN PRESSURE. PRIOR TO THE BURST, THE BALLOON WAS MOVED IN DISTAL LM TO THE HIGHLY CALCIFIED LESION IN THE PROXIMAL CX. IT WAS REPORTED THAT WHILE THE BALLOON WAS BEING REMOVED INTO THE GUIDE CATHETER, RESISTANCE WAS FELT, AS IF THE BALLOON WAS SNAGGED ON SOMETHING JUST OUTSIDE THE GUIDE CATHETER TIP. FORCE WAS USED TO RETRIEVE THE BALLOON INSIDE THE GUIDE CATHETER. AGAIN, FURTHER SNAG-LIKE RESISTANCE WAS FELT AND FURTHER FORCE WAS APPLIED TO PULL THE BALLOON OUT OF THE GUIDE CATHETER. AS REPORTED, THE BALLOON HAD SEPARATED IN HAL F, ONE PART WAS LEFT IN THE GUIDE CATHETER AND THE OTHER ON THE CORONARY WIRE. PART REMAINED ON THE BALLOON SHAFT THAT WAS REMOVED SAFELY AND THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6663275 ↗

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.