Situate 01-0035Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10884521700666), received between Jun 10, 2021 and Dec 1, 2025 — classified as 3 injuries, 15 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (15 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 1, 2025False Positive Result; False Positive Result

  IT WAS REPORTED THAT THE ACCESSORY DID NOT CONNECT TO THE CONSOLE AND WAS DETECTING LAPS EVEN THOUGH THE COUNT WAS CORRECT AND NO LAPS WERE RETAINED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23679934 ↗
• MalfunctionAug 22, 2024False Positive Result; False Positive Result

  ACCORDING TO THE REPORTER, DURING A NORMAL SPONTANEOUS VAGINAL DELIVERY (NSVD) PROCEDURE, THE TWO UNITS WERE SHOWING A POSITIVE DETECTION WHEN THERE WAS NO SPONGE PRESENT. AFTER THE VAGINAL BIRTH, THE REPORTER SCANNED THE PATIENT A FEW TIMES WITH ONE UNIT AND THEN BROUGHT IN ANOTHER UNIT AS WELL, TOTALING ABOUT FIVE MINUTES. IT DELAYED THE PROCESS OF FINISHING UP WITH THE PATIENT AND ALLOWING HER TO GET BACK TO HER NEWBORN BABY. THE REPORTER USED ONE CONSOLE AND VERISPHERE. WHEN THAT DID NOT WORK, THEY USED ANOTHER SYSTEM WHICH INCLUDED ANOTHER CONSOLE AND VERISPHERE. A TOTAL OF TWO CONSOLES AND TWO VERISPHERES. A MANUAL COUNT WAS DONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20027772 ↗
• MalfunctionJul 24, 2024False Positive Result; False Positive Result

  ACCORDING TO THE REPORTER, DURING A NORMAL SPONTANEOUS VAGINAL DELIVERY (NSVD) PROCEDURE, THE TWO UNITS WERE SHOWING A POSITIVE DETECTION WHEN THERE WAS NO SPONGE PRESENT. AFTER THE VAGINAL BIRTH, THE REPORTER SCANNED THE PATIENT A FEW TIMES WITH ONE UNIT AND THEN BROUGHT IN ANOTHER UNIT AS WELL, TOTALING ABOUT 5 MINUTES. IT DELAYED THE PROCESS OF FINISHING UP WITH THE PATIENT AND ALLOWING HER TO GET BACK TO HER NEWBORN BABY. THE REPORTER USED ONE CONSOLE AND VERISPHERE. WHEN THAT DID NOT WORK, THEY USED ANOTHER SYSTEM WHICH INCLUDED ANOTHER CONSOLE AND VERISPHERE. A TOTAL OF TWO CONSOLES AND TWO VERISPHERE. A MANUAL COUNT WAS DONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19817420 ↗
• MalfunctionJul 25, 2023False Negative Result; False Negative Result

  ACCORDING TO THE REPORTER, THE DEVICE HAD FALSE CLEAR/DETECTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17390909 ↗
• MalfunctionJul 25, 2023False Negative Result; False Negative Result

  ACCORDING TO THE REPORTER, THE DEVICE HAD FALSE CLEAR/DETECTIONS. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17390678 ↗
• MalfunctionJul 25, 2023False Negative Result; False Negative Result

  ACCORDING TO THE REPORTER, THE UNIT HAD FALSE CLEAR DETECTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17390414 ↗
• MalfunctionApr 24, 2023False Positive Result; False Positive Result

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD FALSE DETECTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16798601 ↗
• MalfunctionMar 31, 2023False Positive Result; False Positive Result

  ACCORDING TO THE REPORTER, DURING NORMAL USE, THE UNIT SCAN REPORTED A DETECTED OBJECT BUT NO SPONGE WAS THERE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16659215 ↗
• MalfunctionMar 30, 2023False Positive Result; False Positive Result

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE GAVE A "DETECT" MESSAGE WHEN THERE WAS NOT A LAP IN THE AREA. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16644941 ↗
• MalfunctionMar 23, 2023False Positive Result; False Positive Result

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THERE WERE TWO DEVICES AND TWO CONSOLES THAT HAD DETECTION ISSUES. ONE DEVICE AND ONE CONSOLE WERE DETECTED BUT NOT THERE AND THE OTHER DEVICE AND CONSOLE WERE NOT DETECTED BUT PRESENT. BOTH SCANNERS DETECTED A SIGNAL BUT NO SPONGE WAS FOUND. SYSTEMS WERE REPLACED OUT OF PRECAUTION. THERE WAS NO RETAINED SPONGE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 16600367 ↗
• MalfunctionMar 23, 2023False Negative Result; False Positive Result; False Negative Result; False Positive Result

  ACCORDING TO THE REPORTER, INTRA OPERATIVELY, THERE WERE TWO DEVICES AND TWO CONSOLES THAT HAS DETECTION ISSUE, ONE DEVICE AND ONE CONSOLE WAS DETECTED BUT NOT THERE AND THE OTHER DEVICE AND CONSOLE WAS NOT DETECTED BUT PRESENT, BOTH SCANNERS DETECTED A SIGNAL BUT NO SPONGE WAS FOUND. SYSTEMS WERE REPLACED OUT OF PRECAUTION. THERE WAS NO RETAINED SPONGE. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 16598146 ↗
• InjuryJun 13, 2022False Positive Result; False Positive Result

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, MEDTRONIC SITUATE MACHINE SCANNED AND DETECTED SOMETHING IN PATIENT. ATTEMPTED A FEW MORE TIMES WITH THE SAME MACHINE. TROUBLESHOOTING: MOVED DELIVERY TABLE AWAY FROM BED. RECOUNTED ALL GAUZE (COUNT WAS CORRECT). OBTAINED ANOTHER SITUATE MACHINE AND RESCANNED PATIENT, ALL SCANS CAME BACK THAT SOMETHING WAS DETECTED. X-RAY WAS ORDERED FOR VERIFICATION AND TO ENSURE A SPONGE WAS NOT RETAINED INSIDE THE PATIENT. X RAY VERIFICATION CONFIRMED ¿NO ACUTE FINDINGS¿.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 14674323 ↗
• MalfunctionMay 27, 2022False Positive Result; False Positive Result

  ACCORDING TO THE REPORTER, THE DEVICE GIVES FALSE POSITIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14526791 ↗
• MalfunctionMay 27, 2022False Positive Result; False Positive Result

  ACCORDING TO THE REPORTER, THE DEVICE WAS GIVING FALSE POSITIVE DETECTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14526729 ↗
• InjuryMay 18, 2022False Positive Result; False Positive Result

  ACCORDING TO THE REPORTER, AFTER VAGINAL DELIVERY, THE DEVICE HAD A SCAN ERROR MESSAGE. ALL COUNTS WERE CORRECT/ALL RAYTEC'S VISUALIZED. SCANNED PATIENT LOW ABD/SUPRAPUBIC WHICH INDICATED A RETAINED SPONGE. REPEATED SCAN WITH SAME RESULTS. ATTEMPTED SCAN WITH ANOTHER MACHINES WITH SAME RESULTS. ENSURED CORD WAS NOT ON OR AROUND PATIENT WHILE SCANNING. FINALLY DOCUMENTED THE CONFIRMATION NUMBER IN PATIENT CHART WITH THE LAST SCAN. DELIVERY TABLE MOVED AWAY FROM PATIENT. VISUAL CHECK UNDER AND AROUND PATIENT. CHECKED ALL OPEN RAYTECS ON DELIVERY TABLE FOR RFID DETECTION DEVISE. NONE WERE MISSING. THE DOCTOR REQUESTED TO RE-EXAMINE THE PATIENT. THEY DID A VAGINAL EXAM AND NOTHING WAS FOUND. RECOUNTED RAYTEC ON DELIVERY TABLE AND COUNTS WERE AGAIN CORRECT. ORDERED PORTABLE PELVIC X-RAY, WHICH WAS NEGATIVE. AFTER X-RAY RESULTS, FINALLY BROKE DOWN THE TABLE WITH SPONGES. EVERYTHING WAS EXPLAINED TO THE PATIENT INCLUDING THE MD TO SHOW THE PATIENT THE SPONGES. BOTH MACHINES WERE USED EARLIER IN THE SHIFT AND DID NOT DETECT ANYTHING. MACHINES ARE CURRENTLY IN THE OFFICE, SO THEY ARE NOT USED UNTIL EXAMINED BY BIOMED OR MEDTRONIC REPRESENTATIVE. THERE WAS NO PATIENT INJURY.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 14429453 ↗
• InjuryMay 18, 2022False Positive Result; False Positive Result

  ACCORDING TO THE REPORTER, AFTER VAGINAL DELIVERY, THE DEVICE HAD A SCAN ERROR MESSAGE. ALL COUNTS WERE CORRECT/ALL RAYTEC'S VISUALIZED. SCANNED PATIENT LOW ABD/SUPRAPUBLIC WHICH INDICATED A RETAINED SPONGE. REPEATED SCAN WITH SAME RESULTS. ATTEMPTED SCAN WITH ANOTHER MACHINES WITH SAME RESULTS. ENSURED CORD WAS NOT ON OR AROUND PATIENT WHILE SCANNING. FINALLY DOCUMENTED THE CONFIRMATION NUMBER IN PATIENT CHART WITH THE LAST SCAN. DELIVERY TABLE MOVED AWAY FROM PATIENT. VISUAL CHECK UNDER AND AROUND PATIENT. CHECKED ALL OPEN RAYTECS ON DELIVERY TABLE FOR RFID DETECTION DEVISE. NONE WERE MISSING. THE DOCTOR REQUESTED TO RE-EXAMINE THE PATIENT. THEY DID A VAGINAL EXAM AND NOTHING WAS FOUND. RECOUNTED RAYTEC ON DELIVERY TABLE AND COUNTS WERE AGAIN CORRECT. ORDERED PORTABLE PELVIC X-RAY, WHICH WAS NEGATIVE. AFTER X-RAY RESULTS, FINALLY BROKE DOWN THE TABLE WITH SPONGES. EVERYTHING WAS EXPLAINED TO THE PATIENT INCLUDING THE MD TO SHOW THE PATIENT THE SPONGES. BOTH MACHINES WERE USED EARLIER IN THE SHIFT AND DID NOT DETECT ANYTHING. MACHINES ARE CURRENTLY IN THE OFFICE, SO THEY ARE NOT USED UNTIL EXAMINED BY BIOMED OR MEDTRONIC REPRESENTATIVE. THERE WAS NO PATIENT INJURY.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 14429369 ↗
• MalfunctionJan 6, 2022False Positive Result; False Positive Result

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE BALL GAVE FALSE POSITIVE. ANOTHER UNIT WAS USED AND WORKED FINE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13177252 ↗
• MalfunctionJun 10, 2021False Positive Result; False Positive Result

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE DETECT A SPONGE BUT NO SPONGE PRESENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11979252 ↗