Euphora™ EUP2010XRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169559875), received between Apr 19, 2017 and Jul 12, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ATTEMPT WAS MADE TO USE A NC EUPHORA BALLOON CATHETER TO TREAT A LESION LOCATED IN THE LEFT CIRCUMFLEX ARTERY. THE LESION WAS PRE-DILATED USING A 2.5 X 6MM EUPHORA RX BALLOON CATHETER AND WAS INFLATED AT 14ATM. A 2.5 X 18MM NON-MDT STENT WAS THEN IMPLANTED INTO THE LESION. THE NC EUPHORA DEVICE WAS INSERTED INTO THE NON-MDT STENT. AFTER THE BALLOON WAS PLACED INSIDE THE STENT IT WAS INFLATED AT 6ATM BUT EITHER THE BALLOON DID NOT INFLATE OR IT COULD NOT BE SEEN UNDER FLUORO. THE TECHNICIAN PULLED NEGATIVE ON THE INFLATION DEVICE AND RE-INFLATED THE BALLOON AT 12ATM AND THIS TIME THE BALLOON WAS SEEN TO BE INFLATED UNDER FLUORO. THE BALLOON WAS INFLATED FOR A DIRECTED TIME AND THEN THE INFLATION DEVICE WAS PULLED NEGATIVE TO DEFLATE THE BALLOON. IT WAS REPORTED THAT THE BALLOON WOULD NOT DEFLATE AND WAS STILL INSIDE THE PATIENT. MULTIPLE ATTEMPTS WERE MADE TO DEFLATE THE BALLOON WITH DIFFERENT DEVICES INCLUDING, BALLOONS, SNARES, WIRES, CATHETERS, MICRO-CATHETERS AND GUIDES, BUT ALL ATTEMPTS WERE UNSUCCESSFUL. IT WAS ALSO REPORTED THAT AT SOME POINT IN TIME THE ARTERY DISSECTED AND THE SHAFT OF THE NC EUPHORA DEVICE BROKE OFF. AFTER THE SHAFT BROKE THE BALLOON REMAINED INFLATED A

  Patient problems: Vascular Dissection

  MAUDE report 14985073 ↗
• InjuryApr 19, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  THE PHYSICIAN INTENDED TO USE A EUPHORA BALLOON CATHETER IN A LESION IN THE PROXIMAL LAD, SEVERE CALCIFICATION, SEVERE TORTUOSITY AND 70 % STENOSIS. THERE WAS NO DAMAGE NOTED TO PACKAGING, NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM THE HOOP. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS PRE-DILATED. THE EUPHORA BALLOON DID PASS THROUGH A PREVIOUSLY DEPLOYED OLD STENT IN THE LAD. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. DURING REMOVAL OF THE DEVICE IT IS REPORTED THAT BALLOON DETACHED. A STENT WAS USED TO JAIL THE DETACHED PORTION AGAINST THE VESSEL WALL. THE DEVICE WAS NOT KINKED AND RE-STRAIGHTENED DURING USE.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 6502893 ↗

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.