Emprint SXRecalls & reported problems across all models
Covidien LP · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 21
- Deaths reported
- 1
- Injuries reported
- 8
- Recalls
- 0
We found 6 models of Emprint SX by Covidien LP in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between Aug 27, 2018 and Mar 13, 2026 — classified as 1 death, 8 injuries, 12 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (14 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Emprint SX problems
Device problems
- Detachment of Device or Device Component14
- Adverse Event Without Identified Device or Use Problem3
- Appropriate Device Problem Term/Code Not Available2
- Defective Device2
- Material Fragmentation2
- Break1
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- Insufficient Information5
- Foreign Body In Patient3
- Unintended Radiation Exposure3
- No Consequences Or Impact To Patient2
- Cardiac Arrest1
- Death1
- Low Blood Pressure/ Hypotension1
Emprint SX models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Emprint SX CABK8666LSYSTEM, ABLATION, MICROWAVE AND ACCESSORIES15 reports
- Emprint SX CA15L2NSYSTEM, ABLATION, MICROWAVE AND ACCESSORIES1 death2 reports
- Emprint SX CASYS100SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES1 report
- Emprint SX CA30L2NSYSTEM, ABLATION, MICROWAVE AND ACCESSORIES1 report
- Emprint SX CAAL9150LSYSTEM, ABLATION, MICROWAVE AND ACCESSORIES1 report
- Emprint SX CABK8816SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES1 report
Recent Emprint SX adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionNov 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING PROCEDURE, IT WAS NOTICED THAT THE TIP WAS BROKEN, NOT OFF, WHEN SENSOR WAS REMOVED FROM THE PATIENT. AS SENSOR WAS REMOVED FROM THE PATIENT, IT WAS OBSERVED THAT THE TIP THAT SECURED THE SENSOR TIP TO THE ULTRASOUND PROBE WAS BENT. THE TECH TOOK BOTH ITEMS, REMOVED THE SENSOR FROM THE ULTRASOUND PROBE AND BENT THE TIP OFF, BREAKING IT OFF. THE SENSOR PROBE WAS PLACED ON THE ULTRASOUND UNIT THAT ALREADY HAD A PLASTIC SHEATH OVER IT. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH INCIDENT DEVICE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20695001 ↗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 19143743 ↗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 ↗
Other Covidien LP products
- Endo GIA48 models · 26,277 reports · 8 recalls
- Endo GIA Ultra3 models · 15,650 reports
- Shiley387 models · 9,392 reports · 5 recalls
- Signia16 models · 8,201 reports · 6 recalls
- LigaSure32 models · 7,283 reports · 1 recall
- Tri-Staple 2.037 models · 4,892 reports · 2 recalls
- Polysorb291 models · 4,564 reports · 2 recalls
- EEA39 models · 4,432 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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