Paladin 5.5.x20Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00851616007477), received between Apr 17, 2026 and Apr 17, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Activation Problem” (1 report).

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.

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.

• MalfunctionApr 17, 2026Activation Problem

  EVENT DESCRIPTION: IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT PLAQUE IN THE MID RIGHT CAROTID ARTERY USING THE PALADIN PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY IEP SYSTEM, THERE WAS A DELAY IN SURGERY OF THREE MINUTES DUE TO A PRODUCT ISSUE. THE ARTERY DIAMETER WAS 5.5MM WITH MODERATE TORTUOSITY. A 6FR SHEATH AND A .035 GUIDEWIRE WERE USED. A EMBOLIC PROTECTION DEVICE WAS USED. THE VESSEL WAS POST-DILATED. NO RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. IT WAS REPORTED THAT THE PALADIN FILTER WOULD NOT OPEN. THE DEVICE WAS SAFELY REMOVED, AND THE PROCEDURE WAS COMPLETED USING A NEW PALADIN 5.0X20 DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. INVESTIGATION: THE PRELIMINARY INVESTIGATION DETERMINED THAT THE FILTER COULD NOT BE OPENED WITH A GUIDEWIRE IN PLACE. CONCLUSIONS THE MECHANISM TO ACTUATE THE FILTER DID NOT PERFORM AS EXPECTED. THE DEVICE WAS SAFELY REMOVED AND A SECOND PALADIN DEVICE WAS SUCCESSFULLY USED. THERE WERE NOT PATIENT COMPLICATIONS AS A RESULT OF THIS OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24918445 ↗