Auto Suture OMST12BTNLRecalls & reported problems
Covidien LP · Blunt Tip Trocar · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Covidien Auto Suture blunt tip trocar is a port used in laparoscopic surgery. The 47 reports mostly describe the rubber valve seal coming loose or breaking off, sometimes as mesh is pushed through the port, which lets gas leak out and can drop a small part into the abdomen. There are no deaths and no injuries. One recall, started in February 2024 and still open, cites the potential for the trocar seal to disengage when mesh products are used with it.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 60
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 10884521552449), received between Aug 22, 2018 and Sep 18, 2026 — classified as 60 malfunctions.
The most frequently reported specific device problem is “Break” (39 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Feb 28, 2024Open, Classified
The potential for trocar seal disengagement when using mesh products incorrectly with the device.
Z-1471-2024 · Root cause: Labeling design · FDA record ↗
Most reported problems
Device problems
- Break39
- Detachment of Device or Device Component19
- Leak/Splash13
- Decrease in Pressure5
- Material Split, Cut or Torn3
- Gas/Air Leak2
- Packaging Problem2
- Device Contamination with Chemical or Other Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions51
- Insufficient Information6
- Foreign Body In Patient2
- No Consequences Or Impact To Patient2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 60 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Break; Leak/Splash
Patient problems: Insufficient Information
MAUDE report 50829152 ↗MalfunctionSep 16, 2026Break; Leak/Splash
It was reported that during a laparoscopic colon procedure, the balloon broke and leaked air.
Patient problems: Insufficient Information
MAUDE report 50791980 ↗MalfunctionSep 16, 2026Break
It was reported that during a laparoscopic procedure, the balloon was broken.
Patient problems: Insufficient Information
MAUDE report 50790937 ↗MalfunctionSep 16, 2026Break
It was reported that during a laparoscopic colon procedure, a trocar balloon physically broke during trocar access. The balloon reportedly lost air and/or broke. The device was replaced with another balloon trocar and the procedure was completed. No patient injury was reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50790411 ↗MalfunctionSep 16, 2026Break; Leak/Splash
It was reported that during a laparoscopic colon procedure, the balloon broke and leaked air.
Patient problems: Insufficient Information
MAUDE report 50787144 ↗MalfunctionSep 16, 2026Break; Leak/Splash
It was reported that during a laparoscopic colon procedure, the balloon broke and leaked air.
Patient problems: Insufficient Information
MAUDE report 50786960 ↗MalfunctionSep 12, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50745219 ↗MalfunctionSep 12, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50745166 ↗MalfunctionSep 12, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50745164 ↗MalfunctionSep 12, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50745163 ↗MalfunctionSep 12, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50745157 ↗MalfunctionSep 12, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50745146 ↗MalfunctionSep 12, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50745139 ↗MalfunctionAug 12, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50218941 ↗MalfunctionAug 12, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50218813 ↗MalfunctionAug 12, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50218807 ↗MalfunctionJan 12, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A LAPAROSCOPIC COLOSTOMY TAKEDOWN PROCEDURE, SPECIFICALLY DURING LYSIS OF ADHESIONS, THE VALVE SEAL DISENGAGED AND THE VALVE BECAME STUCK IN THE OPEN POSITION. THE SURGEON IMMEDIATELY PLUGGED THE OPENING WITH A FINGER TO PREVENT LOSS OF PNEUMOPERITONEUM, AND THE PORT WAS REPLACED WITH ANOTHER MANUFACTURER'S PORT 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 24036626 ↗MalfunctionDec 24, 2025Decrease in Pressure; Detachment of Device or Device Component; Decrease in Pressure; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING THE LAPAROSCOPIC LEFT INGUINAL HERNIA REPAIR WITH MESH, THE GREY RUBBER VALVE GASKET SEAL ON THE TOP OF THE TROCAR DISLODGED WHILE MESH WAS BEING INSERTED THROUGH THE TROCAR. ADDITIONALLY, THERE WAS A RAPID LOSS OF ABDOMINAL PRESSURE. ANOTHER TROCAR WAS INSERTED TO FINISH THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23891488 ↗MalfunctionDec 8, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING THE LAPAROSCOPIC INGUINAL HERNIA REPAIR WITH MESH, THE GREY OR SILVER RUBBER VALVE GASKET OF THE DEVICE BECAME UNGLUED FROM THE TOP OF THE TROCAR WHILE THE SURGEON WAS INSERTING MESH. THE SURGEON OBSERVED THE DISENGAGEMENT AND PREVENTED THE VALVE SEAL GASKET FROM FALLING INTO THE PATIENT¿S ABDOMEN. THE CASE WAS COMPLETED USING THE AFFECTED TROCAR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23752167 ↗MalfunctionNov 5, 2025Decrease in Pressure; Detachment of Device or Device Component; Decrease in Pressure; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A LAPAROSCOPIC INGUINAL HERNIA PROCEDURE, THE VALVE SEAL OF THE TROCAR BECAME UNGLUED AND DISENGAGED WHEN THE SURGEON ATTEMPTED TO INTRODUCE MESH INTO THE ABDOMINAL CAVITY THROUGH THE TROCAR PORT. THE VALVE SEAL DETACHED AND NEARLY FELL INTO THE PATIENT CAVITY, BUT THE SURGEON WAS ABLE TO CATCH IT BEFORE THIS OCCURRED. THERE WAS A RAPID LOSS OF ABDOMINAL PRESSURE DUE TO THE DEVICE ISSUE. THE DEVICE WAS REPLACED WITH A COMPETITIVE TROCAR 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 23473827 ↗MalfunctionOct 15, 2025Leak/Splash; Detachment of Device or Device Component; Material Split, Cut or Torn; Leak/Splash; Detachment of Device or Device Component; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING A LAPAROSCOPIC INGUINAL HERNIA PROCEDURE, THE TROCAR WAS BEING USED WHEN THE SURGEON NOTICED INSUFFLATION LEAKING OUT OF THE TOP OF THE TROCAR AND SUBSEQUENTLY IDENTIFIED THAT THE RUBBER 12MM VALVE/SEAL GASKET WAS MISSING AFTER PUSHING MESH INSIDE THE ABDOMEN. THE VALVE SEAL WAS FOUND TO BE DAMAGED, AND THE RUBBER 12MM VALVE/SEAL GASKET HAD FALLEN INTO THE CAVITY OF THE PATIENT. THE COMPONENT WAS EASILY LOCATED AND RETRIEVED AFTER A NEW TROCAR WAS INSERTED. THE CASE WAS COMPLETED AFTER OPENING ANOTHER TROCAR, AND THE PROCEDURE TIME WAS EXTENDED BY 5-7 MINUTES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23291400 ↗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 21996014 ↗MalfunctionJan 24, 2025Break; Break
IT WAS REPORTED THAT DURING A LAPAROSCOPIC ANTERIOR RESECTION, TWO ACCESS BALLOONS FAILED ON THE SAME PATIENT AS THE BALLOONS BURST. NO DEVICE COMPONENTS FELL INTO THE PATIENT'S CAVITY. THE SURGEON HAD TO USE 3 DIFFERENT BALLOON PORTS DUE TO THE DEVICE ISSUE. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21229549 ↗MalfunctionJan 24, 2025Break; Break
IT WAS REPORTED THAT DURING A LAPAROSCOPIC ANTERIOR RESECTION, TWO ACCESS BALLOONS FAILED ON THE SAME PATIENT AS THE BALLOONS BURST. NO DEVICE COMPONENTS FELL INTO THE PATIENT'S CAVITY. THE SURGEON HAD TO USE 3 DIFFERENT BALLOON PORTS DUE TO THE DEVICE ISSUE. THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21229505 ↗MalfunctionSep 10, 2024Break; Break
ACCORDING TO THE REPORTER, PRIOR TO USE IN A PROCEDURE, THE BALLOON CONTROLLED BEFORE INTRODUCTION INTO THE STOMACH, BUT WAS PIERCED UPON INTRODUCTION. A NEW TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20185637 ↗
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-1465-2024 · Feb 28, 2024 · Open, ClassifiedCovidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SB
- Z-1466-2024 · Feb 28, 2024 · Open, ClassifiedCovidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNL
- Z-1468-2024 · Feb 28, 2024 · Open, ClassifiedCovidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BT
- Z-1467-2024 · Feb 28, 2024 · Open, ClassifiedCovidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSNL
- Z-1469-2024 · Feb 28, 2024 · Open, ClassifiedCovidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTS
- Z-1470-2024 · Feb 28, 2024 · Open, ClassifiedCovidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BT
Other Laparoscope, general & plastic surgery devices
- HIGH DEFINITION LCD MONITOR OEV262HOlympus Medical Systems Corp. · Laparoscope, general & plastic surgery1,937 reports
- HD AUTOCLAVABLE CAMERA HEAD OTV-S7ProH-HD-12EOlympus Medical Systems Corp. · Laparoscope, general & plastic surgery1,886 reports
- HD AUTOCLAVABLE CAMERA HEAD OTV-S7ProH-HD-10EOlympus Medical Systems Corp. · Laparoscope, general & plastic surgery1,086 reports
- Auto Suture OMS-T10BTCovidien LP · Laparoscope, general & plastic surgery1 recall955 reports
- PDB OMS-PDB1000Covidien LP · Laparoscope, general & plastic surgery859 reports
- VISERA 4K UHD CAMERA CONTROL UNIT OLYMPUS OTV-S400Olympus Medical Systems Corp. · Laparoscope, general & plastic surgery777 reports
- Auto Suture OMS-T10SBCovidien LP · Laparoscope, general & plastic surgery1 recall697 reports
- Spacemaker SMBTTRNDXCovidien LP · Laparoscope, general & plastic surgery590 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.