Emprint CA15L1 (UDI 10884521725942)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521725942), received between Jan 30, 2019 and Jul 26, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Alarm System” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 26, 2022Overheating of Device; Intermittent Energy Output; Overheating of Device; Intermittent Energy Output

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE TEMPERATURE WAS TOO HIGH BUT THE OUTPUT POWER WAS STOPPED AT 80 WATTS IN 5-MINUTES. THERE WAS NO PROBLEM WITH ICE WATER. THE OPERATION WAS INTERRUPTED TO REPLACE THE DEVICE WITH ANOTHER NEEDLE. THE PATIENT WAS ALREADY UNDER ANESTHESIA AND THE SURGERY WAS COMPLETED THE SAME DAY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15105804 ↗
• InjuryMar 11, 2019Device Alarm System; Temperature Problem; Device Alarm System; Temperature Problem

  ACCORDING TO THE REPORTER, DURING ABLATION, THERE WAS A TEMPERATURE ALARM APPEARED. RESTARTED THE MACHINE, BUT THE ISSUE WAS NOT SOLVED. PROCEDURE WAS CANCELLED WITH PATIENT UNDER ANESTHESIA. HOSPITAL PLANS TO COMMUNICATE WITH THE PATIENT AFTER ONE MONTH FOR RESCHEDULING OF PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 8408272 ↗
• InjuryJan 30, 2019Material Twisted/Bent; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING ABLATION PROCEDURE, THE DEVICE BENT AS IT PASSED THROUGH THE PATIENT'S COSTAL CARTILAGE. PROCEDURE WAS ABORTED AND RESCHEDULED. PATIENT HAD COMPLETED TREATMENT FROM RESCHEDULED AND COMPLETED SURGERY.

  Patient problems: No Code Available

  MAUDE report 8288498 ↗