Emprint CA30L2 (UDI 10884521706606)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521706606), received between Mar 15, 2021 and Nov 1, 2021 — classified as 2 malfunctions.

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

2 FDA recall records name this device's identifier, 2 still open.

2 other recalls cover devices cleared under the same FDA submission (K163105); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Nov 15, 2018Open, Classified

   The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.

   Z-0625-2019 · Root cause: Nonconforming Material/Component · FDA record ↗

2. Aug 7, 2017Open, Classified

   The firm received consumer reports of the ceramic trocar tip of the Emprint ablation antenna disengaging from the needle shaft post-ablation. This can result in the tip remaining in the patient.

   Z-0561-2018 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 1, 2021Device Alarm System; Adverse Event Without Identified Device or Use Problem; Device Alarm System; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE HAD AN ALARM ISSUE. THE MACHINE SHOWED "TEMPERATURE ERROR" WITH COOLING SYSTEM TURNED ON AND SALINE FLOW WAS NOT OBSTRUCTED BUT CANNOT FIND THE REASON. THEY CLEARED THE ALARM BY PRESSING RESET, BUT THE ALERT MARK SHOWED AGAIN. THEY TRIED A DEMO DEVICE AND IT WORKED FINE. PROCEDURE WAS CANCELLED AND RESCHEDULED WHILE THE PATIENT WAS UNDER ANESTHESIA. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12726520 ↗
• MalfunctionMar 15, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN ABLATION PROCEDURE, THE TOP OF THE ANTENNA BROKE. THERE WAS NO ARTIFACT LEFT IN PATIENT. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE UNIT'S TIP WAS DETACHED, MISSING AND WAS NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11488648 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K163105. One submission often covers many models, so check the product and lot details in each record.

• Z-0626-2019 · Nov 15, 2018 · Open, Classified
  Covidien Emprint Short Percutaneous Antenna with Thermosphere Technology, Material CA15L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation)
• Z-0627-2019 · Nov 15, 2018 · Open, Classified
  Covidien Emprint Standard Percutaneous Antenna with Thermosphere Technology, CA20L2 intended for use in percutaneous, laparoscopic, and intraoperative coagulation (ablation) of sof