Emprint SX CA15L2NRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521703278), received between Aug 27, 2018 and Nov 29, 2018 — classified as 1 death, 1 injury.

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

• DeathNov 29, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING AN ABLATION PROCEDURE, THE LESION WAS ABOUT 10-12CM DEEP IN THE LIVER WHERE THE SURGEON HAD TO AVOID LUNG, HEART, AND DIAPHRAGM. THE PHYSICIAN PLACED NEEDLE AND READJUSTED A FEW TIMES; WITH THE MOVEMENT IN AND OUT OF THE COMPUTED TOMOGRAPHY (CT) SCANNER. THE CT SCANNED IMMEDIATELY AFTER RE-POSITIONING SHOWED A LOT OF BLOOD, BUT THE PATIENT WAS STABLE. THE PATIENT WAS TREATED FOR 10 MINUTES AT 100W, TREATED ADDITIONAL 5 MINUTES WITH MINIMAL REPOSITIONING. THE PROCEDURE LASTED FOR OVER 2 HOURS; GENERATOR FUNCTIONED NORMALLY. POST-TREATMENT CT IMAGE SHOWED BLOOD IN THE ABDOMEN; DESCRIBED AS ¿MODERATE¿ AMOUNT OF BLEEDING AND REPEAT CT OBTAINED SHORTLY AFTER SHOWING REDUCTION IN THE AMOUNT OF BLOOD IN CAVITY. POST-PROCEDURE THE PATIENT BECAME HYPOTENSIVE AND HEMODYNAMICALLY UNSTABLE. IT IS "UNCLEAR OF" THE RESUSCITATION EFFORTS, BUT THE PATIENT WAS GIVEN MULTIPLE BLOOD TRANSFUSIONS. THE PATIENT NEVER REGAINED STABILITY AND EXPIRED 6 HOURS POST ABLATION.

  Patient problems: Death; Low Blood Pressure/ Hypotension

  MAUDE report 8117574 ↗
• InjuryAug 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, APPROXIMATELY 30 SECONDS AFTER ABLATION OF THE JUXTACARDIAC (S2¿S LESION UNDER THE DIAPHRAGM) TUMOR WITH AN OUTPUT OF 100 W WITH EMPRINT CAUGHT A CARDIAC ARREST FOR ABOUT 10 SECONDS FROM THE HIGH BRADYCARDIA. WHEN ABLATION WAS STOPPED IMMEDIATELY, THE HEART BEAT RESUMED, THE PATIENT FINISHED WITHOUT SEQUELAE. THE HEART AND ABLATION PREDICTION RANGE WAS ABOUT 2 CM APART AND IT WAS JUDGED THAT IT WAS SAFE TO BURN AND IT WAS TREATED. THE PROCEDURE WAS NOT COMPLETED AND NEED A RE-OPERATION DUE TO THE ISSUE.

  Patient problems: Cardiac Arrest

  MAUDE report 7819699 ↗