Auto Suture OMS-T10BTSRecalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10884521081079), received between Mar 23, 2017 and Dec 12, 2025 — classified as 1 injury, 34 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (17 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-1469-2024 · Root cause: Labeling design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTALLY EXTRAPERITONEAL HERNIA, WHEN THE SURGEON WAS ABOUT TO BEGIN, THE UPPER VALVE DISENGAGED FROM THE TROCAR, AND AFTER THAT, THE SURGEON INFLATED THE TROCAR, AND IT EXPLODED. A NEW TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23791380 ↗
• MalfunctionAug 27, 2025Break; Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE RETAINING RING OF THE TROCAR BROKE AND COULD NOT HOLD THE TROCAR. THE DEVICE WAS REPLACED 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 22905984 ↗
• InjuryMay 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, A PIECE OF PLASTIC DETACHING FROM THE INTERNAL SLEEVE OF THE TROCAR AND WAS FOUND IN THE ABDOMEN.

  Patient problems: Foreign Body In Patient

  MAUDE report 22040364 ↗
• MalfunctionMay 7, 2024Difficult to Insert; Difficult to Insert

  ACCORDING TO THE REPORTER, DURING AN ACUTE APPENDICITIS PROCEDURE, THERE WAS DIFFICULTY INSERTING THE 10-MILLIMETER LENS INTO THE TROCAR. IT COULD NOT SLIDE INTO THE TROCAR SHEATH AS IT WAS BLOCKED. ANOTHER TROCAR WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 19261661 ↗
• MalfunctionDec 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTALLY EXTRAPERITONEAL HERNIA REPAIR, DURING MESH INSERTION THROUGH THE CANNULA, THE VALVE HAS BEEN DISLODGING EVERY SECOND AS IF THE DEVICE DID NOT HAVE ANY GLUE AT ALL. THE DEVICE KEPT COMING OUT SO EASILY. THE SURGEON HAS DEVELOPED MULTIPLE STRATEGIES TO CONTINUE THE OPERATION INCLUDING RE-POSITIONING THE SEAL BACK INTO POSITION. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18272664 ↗
• MalfunctionDec 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTALLY EXTRAPERITONEAL HERNIA REPAIR, DURING MESH INSERTION THROUGH THE CANNULA, THE VALVE HAS BEEN DISLODGING EVERY SECOND AS IF THE DEVICE DID NOT HAVE ANY GLUE AT ALL. THE DEVICE KEPT COMING OUT SO EASILY. THE SURGEON HAS DEVELOPED MULTIPLE STRATEGIES TO CONTINUE THE OPERATION INCLUDING RE-POSITIONING THE SEAL BACK INTO POSITION. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18272369 ↗
• MalfunctionDec 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTALLY EXTRAPERITONEAL HERNIA REPAIR, DURING MESH INSERTION THROUGH THE CANNULA, THE VALVE HAS BEEN DISLODGING EVERY SECOND AS IF THE DEVICE DID NOT HAVE ANY GLUE AT ALL. THE DEVICE KEPT COMING OUT SO EASILY. THE SURGEON HAD DEVELOPED MULTIPLE STRATEGIES TO CONTINUE THE OPERATION INCLUDING RE-POSITIONING THE SEAL BACK INTO POSITION. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18268939 ↗
• MalfunctionJun 29, 2023Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, THE TROCAR BALLOON DID NOT INFLATE. WHEN IT DOES, IT DOES NOT STAY INFLATED.

  Patient problems: Insufficient Information

  MAUDE report 17226887 ↗
• MalfunctionJun 21, 2023Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HEMICOLECTOMY, THE VALVE SEAL WAS DAMAGED AND SHEATH DISENGAGED. A NEW TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17172452 ↗
• MalfunctionJun 12, 2023Break; Inflation Problem; Gas/Air Leak; Break; Inflation Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE BALLOON BROKE, DID NOT INFLATE, DEFLATED AND LEAKED GAS/AIR IT WAS ALSO REPORTED THAT THE TROCAR WAS DAMAGED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17109050 ↗
• MalfunctionJun 12, 2023Break; Inflation Problem; Gas/Air Leak; Break; Inflation Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE BALLOON BROKE, DID NOT INFLATE, DEFLATED AND LEAKED GAS/AIR IT WAS ALSO REPORTED THAT THE TROCAR WAS DAMAGED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17108999 ↗
• MalfunctionJun 12, 2023Break; Inflation Problem; Gas/Air Leak; Break; Inflation Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE BALLOON BROKE AND DID NOT INFLATE. DEFLATED AND LEAKED GAS/AIR. IT WAS ALSO REPORTED THAT THE TROCAR WAS DAMAGED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17105950 ↗
• MalfunctionJun 6, 2023Break; Inflation Problem; Gas/Air Leak; Break; Inflation Problem; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, AS THE SURGICAL TEAM WAS PERFORMING THE TROCAR POSITIONING, THE BALLOON BROKE, DID NOT INFLATE, DEFLATED AND LEAKED GAS/AIR IT WAS ALSO REPORTED THAT THE TROCAR WAS DAMAGED. ANOTHER TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17075163 ↗
• MalfunctionApr 11, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING AN EXPLORATORY LAPAROSCOPY, AS SOON AS THE INSUFFLATION STARTED AND THE CAMERA WAS IN THE RIGHT PLACE, THE BALLOON OF THE TROCAR BROKE.

  Patient problems: Insufficient Information

  MAUDE report 16714662 ↗
• MalfunctionApr 5, 2023Break; Break

  ACCORDING TO THE REPORTER, PREOPERATIVELY, LAPAROSCOPIC PROCEDURE, THE BALLOON PHYSICALLY BROKE.

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

  MAUDE report 16682614 ↗
• MalfunctionFeb 21, 2023Break; Inflation Problem; Break; Inflation Problem

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE BALLOON HAD A SMALL HOLE AND WHEN THEY WANTED TO INFLATE, IT COULD NOT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16409257 ↗
• MalfunctionJan 23, 2023Difficult to Insert; Difficult to Insert

  ACCORDING TO THE REPORTER, THE BAG LINK GOT STUCK IN THE TROCAR ENTRY. THE TROCAR HAD TO BE REMOVED TO DISENGAGE THE BAG: VISUAL LOSS OF THE APPENDIX.

  Patient problems: Insufficient Information

  MAUDE report 16224605 ↗
• MalfunctionOct 26, 2022Break; Inflation Problem; Break; Inflation Problem

  ACCORDING TO THE REPORTER, PRIOR TO A PROCEDURE, THE BALLOON DID NOT INFLATE; IT WAS PHYSICALLY BROKEN. A NEW TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15673048 ↗
• MalfunctionMar 16, 2021Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE FOR PEDIATRIC SURGERY, THE THREE BALLOONS WERE VERY HARD TO INFLATE AND DID NOT STAY INFLATED. A FOURTH TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11496015 ↗
• MalfunctionOct 31, 2020Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, PRIOR TO A LAPAROSCOPIC PROCEDURE, THE BALLOON WOULD NOT INFLATE. SURGEON REPLACED THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10767453 ↗
• MalfunctionNov 26, 2019Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, POSTOPERATIVE FROM LAPAROSCOPIC SURGERY, LOSS OF PLASTIC PARTICLES AT THE DISTAL END WAS NOTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9377243 ↗
• MalfunctionNov 15, 2018Inflation Problem; Inflation Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY, THE BALLOON DID NOT INFLATE. THEY OPENED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8074221 ↗
• MalfunctionAug 17, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPY, WHILE INFLATING THE BALLOON PORTION OF THE TROCAR, THE BALLOON PHYSICALLY BROKE. THEY OPENED A NEW ONE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7794335 ↗
• MalfunctionJul 30, 2018Break; Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, AT THE BEGINNING OF THE LAPAROSCOPIC PROCEDURE, WHEN THEY WANTED TO PLACE THE TROCAR, THE BALLOON WAS PIERCED AND REDUCER BROKE ITSELF. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7732588 ↗
• MalfunctionMar 28, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC OVARIAN CYSTECTOMY, WHILE INFLATING THE BALLOON, IT POPPED. THEY OPENED A NEW PRODUCT TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7378852 ↗

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-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-1470-2024 · Feb 28, 2024 · Open, Classified
  Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BT
• Z-1466-2024 · Feb 28, 2024 · Open, Classified
  Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNL
• Z-1468-2024 · Feb 28, 2024 · Open, Classified
  Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BT
• Z-1465-2024 · Feb 28, 2024 · Open, Classified
  Covidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SB