Emprint CA30L1 (UDI 10884521725966)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521725966), received between Jul 21, 2021 and Apr 3, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 reports).

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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 3, 2023Leak/Splash; Appropriate Device Problem Term/Code Not Available; Leak/Splash; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THERE WAS A LEAK PRESENT. THE PROCEDURE WAS ABORTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16664275 ↗
• MalfunctionAug 19, 2022Leak/Splash; Material Twisted/Bent; Leak/Splash; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE HAD CREASES AND WATER LEAKAGE. THE PROCEDURE WAS ABORTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15261783 ↗
• MalfunctionJul 21, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING ABLATION PROCEDURE, THE DEVICE BREAKS DURING USE ON THE PATIENT. A PHOTO WAS ATTACHED SHOWING THE DEVICE TIP (GREEN PLASTIC PART) WAS DETACHED. NOTHING FELL INTO THE PATIENT'S CAVITY. BROKEN PIECE WAS RETRIEVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12203770 ↗