Emprint CA15L1 (UDI 10884521806511)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521806511), received between Oct 18, 2021 and Jan 31, 2024 — classified as 5 malfunctions.

The most frequently reported specific device problem is “No Flow” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 31, 2024Break; Overheating of Device; No Flow; Adverse Event Without Identified Device or Use Problem; Break; Overheating of Device; No Flow; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE PATIENT UNDERWENT MICROWAVE ABLATION. AFTER THE MICROWAVE ABLATION NEEDLE WAS PUNCTURED IN PLACE, WHEN THE WATER CIRCULATION WAS TURNED ON, IT WAS FOUND THAT THE CONNECTION PORT OF THE LEATHER STRAP CONNECTING TUBE WAS BROKEN, AND THE WATER CIRCULATION WAS STOPPED IMMEDIATELY. AFTER THE CONNECTION PORT WAS BROKEN, WATER-COOLING CIRCULATION COULD NOT BE PERFORMED, AND THE TEMPERATURE OF THE ABLATION NEEDLE ROSE, CAUSING ABLATION TO BE INTERRUPTED, CAUSING A SURGICAL TO BE SUSPENDED, AND PROLONGING THE SURGICAL TIME. THE CONSUMABLE WAS REPLACED, WHICH AFFECTED THE PROGRESS OF THE SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 18614572 ↗
• MalfunctionJan 29, 2024Device Alarm System; No Flow; Appropriate Device Problem Term/Code Not Available; Device Alarm System; No Flow; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE HAD WATER CIRCULATION PIPELINE FAILURE, COOLING SYSTEM ALARM. THE PROCEDURE WAS NOT PUT OFF UNTIL SOME TIME IN THE FUTURE. THE PROCEDURE WAS COMPLETED ON THE SAME DAY, BUT THE PROCEDURE TIME WAS DELAYED DUE TO PRODUCT FAILURE. THE PROCEDURE WAS STILL COMPLETED USING MICROWAVE ABLATION. PHOTO SHOWED HIGH TEMP ALARM. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18602225 ↗
• MalfunctionMar 19, 2022No Flow; No Flow

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE COOLING SYSTEM THAT PASSES THROUGH THE PUMP BROKE. THEY WERE UNABLE TO PERFORM THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13826269 ↗
• MalfunctionDec 13, 2021Peeled/Delaminated; Peeled/Delaminated

  ACCORDING TO THE REPORTER, DURING ABLATION PROCEDURE, WHEN OPENING THE ANTENNA, THERE WAS A CUT IN WHITE PART. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12983879 ↗
• MalfunctionOct 18, 2021Detachment of Device or Device Component; Material Twisted/Bent; Detachment of Device or Device Component; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING ABLATION, THE ANTENNA WAS BENT WHEN INSERTED DURING NEEDLE GUIDING THEN IT WAS REMOVED. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THE SHAFT WAS BROKEN. ALL PIECES WERE STILL ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12646417 ↗