Emprint CA20L1 (UDI 10884521806528)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521806528), received between Jan 4, 2023 and Dec 13, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 13, 2023Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE HAD WATER LEAKING AT THE CIRCULATION TUBE CONNECTION. THE PROCEDURE COULD NOT BE COMPLETED, IT WAS INTERRUPTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18320162 ↗
• MalfunctionAug 9, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING ABLATION PROCEDURE, THE MICROWAVE NEEDLE BROKE ABOUT 6 INSIDE SURFACE FROM THE NEEDLE TIP. THE DOCTOR BROKE OPEN THE ABLATION NEEDLE WITH A SCALPEL AND FOUND THAT THE VICINITY OF THE BROKEN NEEDLE WAS MORE LIKELY TO BREAK THAN OTHER PLACES. MICROWAVE PIN WAS FRACTURED. THE OPERATION HAD BEEN COMPLETED AND ANOTHER ONE OF THE SAME TYPE HAD BEEN USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17493975 ↗
• InjuryMay 18, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE NEEDLE WAS INTRODUCE WITHOUT COMPLICATION AND WELL-LOCATED. BEFORE THE CONTROL CT, THE PATIENT HAD COUGH ACCESS AND STARTED TO RETURN SERUM THROUGH THE NEEDLE. BY ULTRASOUND SONOGRAPHY (USG), IT WAS SEEN THAT THE NEEDLE HAD RETRACTED AND THEY OPTED TO REMOVE THE NEEDLE AND NOTE THAT THE TIP PORTION OF THE ANTENNA HAD STAYED IN PATIENT'S LIVER. A NEW NEEDLE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT HAD PROLONGED HOSPITALIZATION AND HAD TO UNDERGO SURGERY TO REMOVE THE PART OF THE NEEDLE THAT STAYED IN THE LIVER (FOREIGN BODY REMOVAL).

  Patient problems: Cough; Pneumothorax

  MAUDE report 16955766 ↗
• MalfunctionJan 4, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SURGICAL PROCEDURE, THE ANTENNA WAS BROKEN OFF DURING REPOSITIONING. NOTHING FELL INTO PATIENT'S CAVITY. THE BROKEN PIECE WAS RECOVERED WITH FORCEPS. PROCEDURE WAS COMPLETED WITH A NEW DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16095295 ↗