Omnicurve 1032-120-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07613327554663), received between May 15, 2023 and Sep 15, 2026 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Fracture

  It was reported that the OmniCurve sheath broke off and was left in the patient. There was no medical intervention, no adverse consequences and no clinically significant surgical delay.

  Patient problems: Foreign Body In Patient

  MAUDE report 50779258 ↗
• MalfunctionMay 12, 2026Fracture

  IT WAS REPORTED THAT A PIECE OF THE CANNULA WAS LEFT IN THE PEDICLE OF THE PATIENT. THE PROCEDURE WAS CANCELLED AND NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25148163 ↗
• MalfunctionMar 18, 2026Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE THE SHEATH BROKE AND REMAINED IN THE PATIENT. THE SHEATH WAS NOT ABLE TO BE REMOVED. THERE WAS NO MEDICAL INTERVENTION, NO ADVERSE CONSEQUENCES AND NO CLINICALLY SIGNIFICANT SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 24627018 ↗
• MalfunctionDec 22, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE THE CONDUIT BROKE AND REMAINED IN THE PATIENT. THERE WAS NO MEDICAL INTERVENTION, NO ADVERSE CONSEQUENCES AND NO CLINICALLY SIGNIFICANT SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 23872299 ↗
• MalfunctionAug 20, 2025Fracture; Fracture

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22849186 ↗
• MalfunctionAug 13, 2025Fracture; Fracture

  NO NEW INFORMATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 22792570 ↗
• MalfunctionNov 18, 2024Fracture; Fracture

  SALES REPRESENTATIVE REPORTED DURING A PROCEDURE THE END OF THE PEAK SHEATH OF AN OMNICURVE BROKE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY; NO ADVERSE CONSEQUENCES OR MEDICAL INTERVENTION WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20711160 ↗
• MalfunctionAug 27, 2024Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE PROCEDURE THE SHEATH GOT STUCK WHILE TRYING TO REMOVE THE THE ACCESS NEEDLE AND THE GREEN WINGS BROKE OFF THE THE PROXIMAL END OF THE DEVICE. IT SHOULD BE NOTED THE THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITH NO PATIENT IMPACT, MEDICAL INTERVENTION, OR ADVERSE CONSEQUENCES. A 5 MINUTE DELAY WAS REPORTED AS WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20075527 ↗
• InjuryAug 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE THE NEEDLE BROKE AND WAS STUCK IN THE PATIENT'S BACK. THE PATIENT HAD TO GO TO A NEUROSURGEON TO REMOVE THE PIECES. THE NEUROSURGEON WAS SUCCESSFUL AT REMOVING THE BROKEN NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19911397 ↗
• MalfunctionAug 15, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE DELIVERY DEVICE SEPARATED DURING THE PROCEDURE AND THERE IS A POSSIBILITY THAT SOME OF THE SHEATH REMAINED IN THE PEDICLE, ALTHOUGH IT CANNOT BE CONFIRMED. IT SHOULD BE NOTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY MEDICAL INTERVENTION, SURGICAL DELAYS, OR ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17548778 ↗
• MalfunctionJul 31, 2023Fracture; Fracture

  IT WAS REPORTED PER SALES REP THAT THE OMNICURVE BALLOON KIT SUSTAINED A BREAK IN THE CURVED CONDUIT. IT SHOULD BE NOTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT IMPACT, SURGICAL DELAYS, AND WITHOUT ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17424908 ↗
• MalfunctionJul 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE PRODUCT BECAME STUCK IN HARD BONE AND UPON REMOVAL, IT BROKE. A SCREW REMOVAL SET WAS USED TO REMOVE THE PIECE THAT WAS STUCK IN THE HARD BONE. IT SHOULD BE NOTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITH NO PATIENT IMPACT, NO SURGICAL DELAYS, AND WITHOUT ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17316709 ↗
• MalfunctionMay 15, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE HANDLE BROKE OFF WHEN REMOVING THE PEEK SHEATH. IT SHOULD BE NOTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY, THERE WAS NO PATIENT IMPACT, MEDICAL INTERVENTION WAS NOT NEEDED, THERE WAS NO DELAYS IN THE PROCEDURE, AND NO ADVERSE EVENTS WERE REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16930518 ↗