Euphora™ EUP3520XRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169560291), received between Nov 12, 2021 and Nov 12, 2021 — classified as 1 injury.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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 · Recall details · FDA record ↗

2. Jul 13, 2017Terminated

   Stylette removal difficulties on the Euphora and Solarice products.

   Z-3136-2017 · Root cause: Process design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 12, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  A EUPHORA RX BALLOON CATHETER WAS ATTEMPTED TO BE USED TO TREAT THE DISTAL LEFT POPLITEAL ARTERY. IT WAS STATED THAT THERE WAS STENOTIC VASCULATURE THROUGH THE LEFT PERIPHERAL VASCULATURE. THE DEVICE WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES NOTED. THE LESION WAS NOT PRE-DILATED. THE DEVICE DID PASS THROUGH A PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED THAT UPON DELIVERY OF THE BALLOON TO THE POPLITEAL ARTERY AND DURING POSITIONING OF THE DEVICE, THE BALLOON SHEARED OFF THE CATHETER SHAFT. THE SHAFT WAS REMOVED SUCCESSFULLY THE BALLOON PORTION WAS TRAPPED AGAINST THE POPLITEAL VESSEL WALL USING A SELF-EXPANDING STENT, WITHOUT APPARENT OBSTRUCTION OF BLOOD FLOW ACROSS THE VESSEL. NO FURTHER PATIENT INJURY REPORTED.

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

  MAUDE report 12802452 ↗

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.