Emprint SX CABK8666LRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10884521703346), received between May 10, 2019 and Mar 13, 2026 — classified as 5 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (13 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 18, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 13, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING LIVER ABLATION, THE FIRST SENSOR WAS OBSERVED BY THE PHYSICIAN TO NOT STAY ATTACHED TO THE DISTAL END OF THE ULTRASOUND PROBE. UPON REMOVAL, THE PHYSICIAN NOTICED THAT BOTH CLIPS HOLDING THE SENSOR BROKE OFF. ONE WAS RETRIEVED FROM THE PATIENT CAVITY. THE OTHER WAS OUTSIDE OF THE PATIENT. IT WAS THOUGHT THAT THE SENSOR MIGHT HAVE BECOME CAUGHT ON THE TROCAR. THE LABELING WAS FOLLOWED THROUGHOUT THE PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 24594073 ↗
• InjuryMar 13, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING LIVER ABLATION PROCEDURE, ON THE SECOND LAP SENSOR, ONLY ONE SIDE OF THE CLIP WAS DAMAGED. IT WASN¿T NOTICED UNTIL IT WAS BEING DISCARDED. BROKEN PIECE WASN¿T FOUND USING CAMERA. NO ADDITIONAL MEDICAL PROCEDURE WAS PERFORMED TO LOCATE THE MISSING PIECE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW PRODUCT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24589448 ↗
• InjuryDec 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT PART OF THE TRACKING SENSOR 'CLIPS' FROM THE DEVICE BROKE OFF DURING LAPAROSCOPIC CASE. THE PIECE BROKE OFF WHEN THE SCRUB TECH PUT THE TRACKING SENSOR ONTO THE ULTRASOUND TRANSDUCER, BEFORE THE FIRST CUT. THE PHYSICIAN LOOKED THOROUGHLY WITH THE CAMERA AND DIDN¿T SEE OR FIND ANY FOREIGN OBJECT IN THE PATIENT CAVITY. X-RAYS WERE PERFORMED AND NOTHING APPEARED IN THE IMAGES. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH A NEW DEVICE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 23744762 ↗
• MalfunctionSep 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING ABLATION; THE LAPAROSCOPIC SENSOR BROKE DURING USE ON PATIENT. THE BROKEN SENSOR WAS RETRIEVED DURING THE PROCEDURE AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22938928 ↗
• InjuryAug 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TIP OF THE ULTRASOUND TRACKER BROKE OFF DURING USE, RESULTING IN A SMALL PIECE REMAINING ON THE SURFACE OF THE LIVER AFTER RETRACTION OF THE TRACKER FROM THE LIVER SPACE. THE BREAK WAS NOTICED DURING FINAL LAPAROSCOPIC VIEWING OF THE LIVER WHEN ABLATION WAS COMPLETED. THERE WAS NO FUNCTIONAL INTERFERENCE, AND A LAPAROSCOPIC REMOVAL OF THE BROKEN PIECE WAS SUCCESSFULLY PERFORMED BY THE PHYSICIAN FOLLOWED BY POST-PROCEDURAL X-RAYS WERE CONDUCTED BEFORE THE PATIENT WAS REMOVED FROM THE TABLE. PATIENT CURRENTLY DOING FINE AND WENT HOME THE NEXT DAY.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 22794743 ↗
• InjuryMay 1, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE REMOVAL OF AN ITEM FROM A PATIENT, THE ITEM BROKE INSIDE THE PATIENT. IT WAS ALSO REPORTED THAT THERE WERE MISSING BROKEN PIECES INSIDE THE PATIENT. FURTHER INFORMATION INDICATED THAT THE LAP PROBE COVER BROKE DUE TO TORQUE ON THE LAPAROSCOPIC ULTRASOUND PROBE. THE LESION WAS LOCATED IN A DIFFICULT-TO-REACH AREA, REQUIRING THE ULTRASOUND PROBE TO BE POSITIONED IN A WAY THAT PLACED SIGNIFICANT PRESSURE ON THE PROBE COVER. THE USER ACKNOWLEDGED THAT THIS WAS LIKELY DUE TO POSITIONAL STRESS AND CONSIDERED IT AN ERROR ON THEIR PART.

  Patient problems: Foreign Body In Patient

  MAUDE report 21940877 ↗
• MalfunctionDec 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, AT THE END OF THE PROCEDURE, THE DEVICE¿S CLIP BROKE OFF INSIDE THE PATIENT. THE BROKEN PIECE WAS RECOVERED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20852780 ↗
• MalfunctionOct 11, 2024Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SURGEON WAS REMOVING THE ULTRASOUND PROBE, THE TIP OF THE ULTRASOUND SENSOR TIP WAS VISUALIZED ON THE LIVER. THIS WAS NOT A COMPLAINT.

  Patient problems: Insufficient Information

  MAUDE report 20434763 ↗
• MalfunctionOct 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SURGEON WAS REMOVING THE ULTRASOUND PROBE, THE TIP OF THE ULTRASOUND SENSOR TIP WAS VISUALIZED ON THE LIVER. BROKEN PIECE WAS RETRIEVED. NO X-RAY NOR ADDITIONAL MEDICAL PROCEDURE PERFORMED TO RETRIEVE THE BROKEN PIECE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20434653 ↗
• MalfunctionOct 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SURGEON WAS REMOVING THE ULTRASOUND PROBE, THE TIP OF THE ULTRASOUND SENSOR TIP WAS VISUALIZED ON THE LIVER. THE SURGEON REMOVED IT AND THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20434651 ↗
• MalfunctionSep 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN ABLATION PROCEDURE, THE SENSOR WAS ATTACHED TO THE NON-MEDTRONIC PROBE AND EVERYTHING WENT FINE. HOWEVER, WHEN REMOVING THE PROBE/TRACKER A SMALL WHITE PIECE OF PLASTIC APPEARED ON THE LIVER. THIS WAS A LAPAROSCOPIC CASE, SO ABLE TO SEE IT CLEARLY AND REMOVED IT AND EVERYTHING WAS FINE. NO X-RAY WAS PERFORMED TO SEE THE BROKEN OFF TIP. IT WAS AFTER THE ABLATION WHEN REMOVING THE ULTRASOUND TRACKING SENSOR, SO NO NEED FOR X-RAY. THEY SAW IT CLEARLY ON CAMERA AND WERE ABLE TO REMOVE IT. NO ADDITIONAL PROCEDURE WAS NEEDED OR PERFORMED. DOCTOR SAID HE DID NOT APPLY STRONG FORCE, BUT PORT WAS NARROW AND HE DID ACKNOWLEDGE THE SMALL FIT OF IT. PATIENT WAS VERY LARGE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20250144 ↗
• MalfunctionAug 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC ABLATION PROCEDURE, A PIECE OF THE ULTRA SOUND TRACKER CLASP BROKE OFF. PIECE WAS RETRIEVED BY THE DOCTOR. NO ADDITIONAL MEDICAL PROCEDURE NEEDED TO REMOVE THE PIECE FROM THE PATIENT. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 20048100 ↗
• InjuryApr 19, 2024Defective Device; Appropriate Device Problem Term/Code Not Available; Defective Device; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE NAVIGATION COMPONENT DID NOT WORK AND ALL DIAGNOSTICS WERE CLEAR ON MACHINE. THE SECOND IMAGE ON THE NAVIGATION SCREEN TO THE RIGHT WAS RAPIDLY BLINKING AND UNABLE TO USE THE NAVIGATION ON THE PROCEDURE. NAVIGATION DID NOT WORK ON THE MACHINE. THE PROCEDURE WAS NOT ABLE TO BE COMPLETED, AND THE PROCEDURE WAS ABORTED.

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

  MAUDE report 19143677 ↗
• MalfunctionJul 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING ABLATION PROCEDURE, A PIECE OF THE DEVICE BROKE OFF INTO THE PATIENT. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE INCIDENT DEVICE. PHOTOS WERE ATTACHED SHOWING THE PIECE THAT BROKE OFF WAS PICKED UP FROM THE CAVITY OF THE PATIENT. THERE WAS NO X-RAY OR ADDITIONAL MEDICAL PROCEDURE NEEDED TO REMOVE THE PIECE FROM THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17398829 ↗
• MalfunctionMay 10, 2019Break; Material Fragmentation; Break; Material Fragmentation

  ACCORDING TO THE REPORTER, DURING A KIDNEY ABLATION, THE PHYSICIAN TRIED TO GET THE TRANSDUCER INTO THE 12 GAUGE TROCAR AND IT COULD NOT FIT IT IN AND THAT IS WHEN THEY NOTICED THE TRACKER WAS NOT ALL THE WAY PINCHED, HE CORRECTED IT AND WAS ABLE TO COMPLETE THE PROCEDURE. BEFORE REMOVING THE TRANSDUCER, THEY NOTICED A PIECE OF PLASTIC RIGHT NEXT TO IT. THE PIECE FELL INTO THE PATIENT CAVITY. THE PHYSICIAN RETRIEVED IT AND PUT THE PIECE OF PLASTIC ALONG WITH THE REMAINDER OF THE CLIP IN A BIO HAZARD BAG. THERE WAS NO PATIENT INJURY. THERE WAS NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8601860 ↗