Auto Suture OMS-T10SBRecalls & reported problems

Summary

The FDA's MAUDE database contains 697 adverse event reports that list this exact device (DI 10884521081086), received between Jan 10, 2017 and Sep 2, 2026 — classified as 7 injuries, 690 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (404 reports).

1 FDA recall record name this device's identifier, 1 still open.

6 other recalls cover devices cleared under the same FDA submission (K924011); they may or may not involve this specific model.

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.

Recalls naming this device

1. Feb 28, 2024Class IIOpen, Classified

   The potential for trocar seal disengagement when using mesh products incorrectly with the device.

   Z-1465-2024 · Root cause: Labeling design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 697 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Inflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50573020 ↗
• MalfunctionAug 28, 2026Inflation Problem

  According to the reporter, during a laparoscopic inguinal hernia repair, after inserting the device, the surgeon could not inflate the balloon. A new balloon was used to resolve the issue. There was no patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50498526 ↗
• MalfunctionJun 19, 2026Inflation Problem

  IT WAS REPORTED THAT DURING THE ACCESS STEP OF A LAPAROSCOPIC PROCEDURE, THE TROCAR ACCESS BALLOON DID NOT INFLATE. FOUR MORE UNITS WERE OPENED AND EACH HAD THE SAME ISSUE UNTIL A REPLACEMENT PRODUCT WAS USED TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25558058 ↗
• MalfunctionJun 19, 2026Inflation Problem

  IT WAS REPORTED THAT DURING THE ACCESS STEP OF A LAPAROSCOPIC PROCEDURE, THE TROCAR ACCESS BALLOON DID NOT INFLATE. FOUR MORE UNITS WERE OPENED AND EACH HAD THE SAME ISSUE UNTIL A REPLACEMENT PRODUCT WAS USED TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25558013 ↗
• MalfunctionApr 16, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A HERNIA REPAIR WITH MESH PLACEMENT, THE WASHER ATTACHED TO THE DEVICE KEPT COMING LOOSE. THE SURGEON FIXED THE DEVICE AND REINSERTED THE MESH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24895168 ↗
• MalfunctionApr 15, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC INGUINAL HERNIA REPAIR, THE VALVE SEAL OF THE TROCAR BALLOON DISENGAGED WHEN MESH WAS PLACED. NO COMPONENT FELL INTO THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24891222 ↗
• MalfunctionApr 9, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, VALVE SEAL DISENGAGEMENT OCCURRED. NO COMPONENT FELL INTO THE PATIENT. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 24830145 ↗
• MalfunctionApr 7, 2026Inflation Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA REPAIR, THE STRUCTURAL BALLOON DID NOT INFLATE. A NEW BALLOON WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24808988 ↗
• MalfunctionApr 7, 2026Inflation Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC TOTALLY EXTRAPERITONEAL (TEP) HERNIA REPAIR, A BALLOON TROCAR WAS USED DURING PRE-PERITONEAL INSERTION. AFTER THE DISSECTING BALLOON WAS USED IN THE USUAL FASHION, THE STRUCTURAL BALLOON WAS DEPLOYED AND THE INTERNAL BALLOON WAS INFLATED; WHEN INSUFFLATION WAS CONNECTED, VISUALIZATION WAS VERY NARROW/POOR AND THE BALLOON APPEARED EXTREMELY TENSE OR OVERLY TIGHT. THE BALLOON DID NOT INFLATE. THE PRESSURE SENSOR DID NOT DETECT THE BALLOON PRESSURE AND PROVIDED LOW FLOW ONLY. AFTER ATTEMPTED TROUBLESHOOTING DUE TO THE POOR VIEW, THE DEVICE WAS CHANGED TO A STRAIGHT 10 MM BALLOON PORT AND THE CASE WAS COMPLETED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24796412 ↗
• MalfunctionApr 6, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE WASHER ATTACHED TO THE DEVICE KEPT COMING LOOSE.

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

  MAUDE report 24789217 ↗
• MalfunctionMar 30, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING INSERTION OF THE MESH IN A HERNIA REPAIR, THE WASHER ATTACHED TO THE DEVICE KEPT COMING LOOSE. THE SURGEON WAS ABLE TO FIX IT AN ULTIMATELY INSERT THE MESH WITH THE DEVICE. THERE WAS A DELAY DUE TO THE DEVICE MALFUNCTION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24726394 ↗
• MalfunctionMar 16, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, THE BALLOON GREY SEAL OF THE TROCAR DISLODGED WHEN INSERTING MESH DOWN THE TROCAR. TWO TROCARS WERE USED AND HAD THE SAME ISSUE. THE BALLOON TROCAR WAS CHANGED TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24613007 ↗
• MalfunctionMar 16, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, THE BALLOON GREY SEAL OF THE TROCAR DISLODGED WHEN INSERTING MESH DOWN THE TROCAR. TWO TROCARS WERE USED AND HAD THE SAME ISSUE. THE BALLOON TROCAR WAS CHANGED TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24613003 ↗
• MalfunctionMar 16, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC TOTALLY EXTRAPERITONEAL HERNIA PROCEDURE INVOLVING MESH INSERTION, THE VALVE SEAL OF THE TROCAR BALLOON DISENGAGED. NO DEVICE COMPONENT FELL INTO THE CAVITY OF THE PATIENT. A NEW DEVICE WAS OPENED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24603772 ↗
• MalfunctionMar 9, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC TOTALLY EXTRAPERITONEAL (TEP) HERNIA REPAIR, WHILE INSERTING MESH, THE VALVE SEAL DISENGAGED. THE ISSUE WAS RESOLVED BY REPOSITIONING AND CONTINUING THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24553465 ↗
• MalfunctionMar 2, 2026Decrease in Pressure; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC TOTAL EXTRAPERITONEAL INGUINAL HERNIA PROCEDURE, THE TROCAR EXPERIENCED VALVE SEAL DISENG AGEMENT, RESULTING IN A SUDDEN RAPID LOSS OF ABDOMINAL PRESSURE MULTIPLE TIMES THROUGHOUT THE PROCEDURE AS INSTRUMENTS WERE PASSED THROUGH THE PORT. THE GREY SEAL CAME AWAY FROM THE PORT REPEATEDLY. THE SURGEON ATTEMPTED TO REPLACE THE SEAL IN ORDER TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24484459 ↗
• MalfunctionFeb 21, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC TOTALLY EXTRAPERITONEAL BILATERAL INGUINAL HERNIA REPAIR, THE GREY SEAL REPEATEDLY CAME FREE FROM THE PORT AS INSTRUMENTS AND MESH WERE PASSED THROUGH, CAUSING PROCEDURAL IRREGULARITIES. THE SURGEON WAS ABLE TO REPLACE THE SEAL USING INSTRUMENTS SUCH AS ARTERY CLIPS TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24410425 ↗
• MalfunctionFeb 10, 2026Detachment of Device or Device Component; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HERNIA PROCEDURE, THE GREY VALVE OF THE BALLOON TROCAR DISLODGED AND DROPPED INTO THE ABDOMINAL CAVITY DURING MESH INSERTION, AND THE VALVE SEAL WAS DAMAGED. THE GREY VALVE WAS RETRIEVED USING LAPAROSCOPIC INSTRUMENTS TO RESOLVE THE ISSUE AND COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24309039 ↗
• MalfunctionFeb 4, 2026Inflation Problem

  IT WAS REPORTED THAT DURING A BILATERAL LAPAROSCOPIC INGUINAL HERNIA REPAIR, WHILE PLACING TROCARS, THE STRUCTURAL BALLOON WOULDN'T ALLOW FOR INSUFFLATION, SURGEON TRIED REPOSITIONING IT WITHIN ABDOMEN SEVERAL TIMES WITH NO RESULTS AND NEW ONE WAS REPLACED. THIS RESULTED IN DELAYED SURGERY TIME FOR LESS THAN 20 MINUTES AND INCREASED TIME PATIENT UNDER ANESTHESIA. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24260542 ↗
• MalfunctionFeb 2, 2026Inflation Problem; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING BALLOON INSERTION IN A LAPAROSCOPIC INGUINAL HERNIA REPAIR, THE SHEATH THAT COVERS THE BALLOON TROCAR FAILED TO RETRACT, RESULTING IN THE BALLOON NOT INFLATING. ANOTHER BALLOON WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24229218 ↗
• MalfunctionJan 29, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A LAPAROSCOPIC INGUINAL HERNIA REPAIR, THE GREY VALVE SEAL DISLODGED WHEN THE MESH, WHICH WAS CUT DOWN, WAS INTRODUCED THROUGH THE TROCAR. THE GREY SEAL FELL INTO THE CAVITY AND WAS RETRIEVED THROUGH THE PORTS WITH LAPAROSCOPIC GRASPERS. A SECOND TROCAR WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24215544 ↗
• MalfunctionJan 12, 2026Inflation Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC BILATERAL INGUINAL HERNIA REPAIR, THE ACCESS BALLOON WAS INSERTED INTO THE ABDOMEN AT THE BEGINNING OF THE PROCEDURE AND THE BALLOON DID NOT INFLATE. THE INSUFFLATION MACHINE DISPLAYED AN OCCLUDED MESSAGE. THE SURGICAL TEAM ATTEMPTED TO INFLATE THE BALLOON USING BOTH THE INSUFFLATION MACHINE AND THE INFLATION BULB, BUT INFLATION WAS UNSUCCESSFUL. AFTER THE PROCEDURE, THE BALLOON WAS ABLE TO BE MANUALLY INFLATED ON THE BACK TABLE USING THE INFLATION BULB. ANOTHER STRUCTURAL BALLOON TROCAR WAS OPENED AND USED WITHOUT ISSUE TO COMPLETE THE CASE. NO ADDITIONAL OPERATION WAS REQUIRED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24040344 ↗
• MalfunctionJan 7, 2026Decrease in Pressure; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC TOTALLY EXTRAPERITONEAL (TEP) INGUINAL HERNIA REPAIR, AS MESH WAS BEING INSERTED THROUGH THE PORT, THE GREY SEAL CAME COMPLETELY LOOSE, RESULTING IN A RAPID LOSS OF ABDOMINAL PRESSURE. THE SURGEON WAS ABLE TO REINSERT THE GREY SEAL INTO ITS PROPER POSITION TO COMPLETE THE CASE, WHICH TOOK LESS THAN 30 MINUTES, DURING WHICH THE PREPERITONEAL SPACE WAS DEFLATED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23992561 ↗
• MalfunctionDec 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA REPAIR, THE O-SEAL BROKE OFF FROM THE TROCAR. NO INTERVENTION WAS PERFORMED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23849884 ↗
• MalfunctionDec 15, 2025Inflation Problem; Material Split, Cut or Torn; Inflation Problem; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING THE START OF A LAPAROSCOPIC PROCEDURE, THE BALLOON TROCAR DID NOT INSUFFLATE AND THE VALVE SEAL WAS DAMAGED. THE ISSUE WAS IDENTIFIED AT THE BEGINNING OF THE PROCEDURE. A NEW DEVICE WAS OPENED TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23812448 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K924011. One submission often covers many models, so check the product and lot details in each record.

• Z-1468-2024 · Feb 28, 2024 · Open, Classified
  Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BT
• Z-1469-2024 · Feb 28, 2024 · Open, Classified
  Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTS
• Z-1467-2024 · Feb 28, 2024 · Open, Classified
  Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSNL
• Z-1471-2024 · Feb 28, 2024 · Open, Classified
  Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTNL
• Z-1466-2024 · Feb 28, 2024 · Open, Classified
  Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNL
• Z-1470-2024 · Feb 28, 2024 · Open, Classified
  Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BT