Auto Suture OMS-T12BTRecalls & reported problems

Summary

The FDA's MAUDE database contains 475 adverse event reports that list this exact device (DI 10884521081093), received between Sep 6, 2016 and Aug 24, 2026 — classified as 16 injuries, 459 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (241 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-1468-2024 · Root cause: Labeling design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 475 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 24, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50420813 ↗
• MalfunctionAug 24, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50420726 ↗
• MalfunctionAug 6, 2026Inflation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50165792 ↗
• MalfunctionJun 18, 2026Inflation Problem

  ACCORDING TO THE REPORTER, DURING THE PRE-OPERATIVE BALLOON INFLATION TEST, AIR WAS INJECTED INTO THE BALLOON USING A SYRINGE, HOWEVER, THE BALLOON FAILED TO MAINTAIN INFLATION. THE PRODUCT WAS REPLACED WITH A NEW ONE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25555078 ↗
• MalfunctionMar 18, 2026Break

  ACCORDING TO THE REPORTER, PREOPERATIVELY, WHEN AIR WAS INFLATED INTO THE BALLOON OUTSIDE THE BODY TO CHECK THE DEVICE, THE BALLOON PHYSICALLY RUPTURED, SO IT WAS NOT USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24626760 ↗
• MalfunctionFeb 10, 2026Inflation Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24307729 ↗
• MalfunctionFeb 9, 2026Break

  IT WAS REPORTED THAT PREOPERATIVELY THERE WAS A HOLE IN THE BALLOON AND THE BALLOON DEFLATED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24288742 ↗
• MalfunctionFeb 4, 2026Inflation Problem

  IT WAS REPORTED THAT DURING A ROBOT-ASSISTED, LAPAROSCOPIC RIGHT PARTIAL NEPHRECTOMY RETROPERITONEAL APPROACH, THE BALLOON FAILED TO INFLATE AFTER INSERTION INTO PATIENT ABDOMEN. PROCEDURE DELAYED LESS THAN 20 MINUTES DUE TO MALFUNCTION WHILE REPLACEMENT WAS ACQUIRED. PORT WENT INTO PERITONEUM CAVITY, NOT RETRO-PERITONEUM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24260246 ↗
• MalfunctionJan 6, 2026Inflation Problem

  ACCORDING TO THE REPORTER, DURING A SURGERY, THE 12MM AUTO SUTURE BLUNT TIP TROCAR WOULD NOT ALLOW GAS THROUGH AND CAUSED THE EQUIPMENT TO READ AS OCCLUSION OF THE TROCAR. THE USER OPENED A SECOND TROCAR AND THE SAME EVENT OCCURRED. ANOTHER TROCAR WAS USED AND FINALLY WORKED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23982498 ↗
• MalfunctionJan 6, 2026Inflation Problem

  ACCORDING TO THE REPORTER, DURING A SURGERY, THE 12MM AUTO SUTURE BLUNT TIP TROCAR WOULD NOT ALLOW GAS THROUGH AND CAUSED THE EQUIPMENT TO READ AS OCCLUSION OF THE TROCAR. THE USER OPENED A SECOND TROCAR AND THE SAME EVENT OCCURRED. ANOTHER TROCAR WAS USED AND FINALLY WORKED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23982376 ↗
• MalfunctionDec 16, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING A PROCEDURE, THE BALLOON DID NOT INFLATE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23816179 ↗
• MalfunctionDec 12, 2025Break; Break

  IT WAS REPORTED THAT PRE-OPERATIVELY, A HOLE WAS IDENTIFIED IN TWO BALLOONS. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23791588 ↗
• MalfunctionDec 12, 2025Break; Break

  IT WAS REPORTED THAT PRE-OPERATIVELY, A HOLE WAS IDENTIFIED IN TWO BALLOONS. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23791572 ↗
• MalfunctionNov 7, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON DID NOT INFLATE PREOPERATIVELY. THE PRODUCT WAS REPLACED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23501695 ↗
• InjuryOct 15, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC ADRENALECTOMY, THE BALLOON TIP PLASTIC PIECE OF THE TROCAR SNAPPED OFF AND FELL INTO THE CAVITY OF THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23288153 ↗
• MalfunctionSep 29, 2025Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE BALLOON WAS ATTEMPTED TO BE INFLATED BUT FAILED. ANOTHER BALLOON TROCAR WAS USED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23176075 ↗
• MalfunctionSep 4, 2025Break; Break

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC CHOLECYSTECTOMY, THE BALLOON BROKE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22963616 ↗
• MalfunctionAug 28, 2025Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, IN TROCAR INSERTION, THE BALLOON DID NOT INFLATE. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22916985 ↗
• MalfunctionAug 22, 2025Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE BALLOON DID NOT INFLATE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22878236 ↗
• MalfunctionAug 4, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, A FRAGMENT OF THE TROCAR BROKE OFF AND FELL INTO THE PATIENT CAVITY. THE DEVICE FRAGMENT WAS RETRIEVED TOWARD THE END OF THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22701498 ↗
• MalfunctionJul 24, 2025Decrease in Pressure; Detachment of Device or Device Component; Material Split, Cut or Torn; Decrease in Pressure; Detachment of Device or Device Component; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC BILATERAL INGUINAL HERNIA PROCEDURE, DURING MESH INSERTION INTO THE TROCAR TO FIXATE OVER THE HERNIA, THE VALVE SEAL WAS DAMAGED AND DISENGAGED, WHICH RESULTED IN A RAPID LOSS OF ABDOMINAL PRESSURE. AN ADDITIONAL TROCAR 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 22586215 ↗
• MalfunctionJul 16, 2025Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE 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 22522693 ↗
• MalfunctionJul 16, 2025Break; Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE ACCESS BALLOON PHYSICALLY BROKE. THE PRODUCT WAS EXCHANGED FOR A NEW ONE 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 22517649 ↗
• MalfunctionMay 9, 2025Inflation Problem; Gas/Air Leak; Inflation Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC COLORECTAL PROCEDURE, TWO BALLOONS DID NOT INFLATE. WHEN THE SURGEON PUT IN AIR IN THE BALLOONS, THE AIR DID NOT STAY IN THE BALLOONS. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21996058 ↗
• MalfunctionApr 30, 2025Decrease in Pressure; Decrease in Pressure

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RADICAL NEPHRECTOMY PROCEDURE, UNABLE TO MAINTAIN PNEUMOPERITONEUM WITH BALLOON PORT INSERTED. BALLOON PORT TESTED BY USER PRIOR TO CASE START, AND AFTER INITIAL INSERTION BY SURGEON. A SECOND BALLOON PORT WAS OPENED, AND PNEUMOPERITONEUM WAS ABLE TO BE ESTABLISHED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21936559 ↗

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-1470-2024 · Feb 28, 2024 · Open, Classified
  Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BT
• Z-1467-2024 · Feb 28, 2024 · Open, Classified
  Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSNL
• Z-1466-2024 · Feb 28, 2024 · Open, Classified
  Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNL
• Z-1471-2024 · Feb 28, 2024 · Open, Classified
  Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTNL
• Z-1465-2024 · Feb 28, 2024 · Open, Classified
  Covidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SB
• Z-1469-2024 · Feb 28, 2024 · Open, Classified
  Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTS