Auto Suture OMS-T10BTRecalls & reported problems
Covidien LP · Blunt Tip Trocar · Class 2
All models of Auto Suture (10)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
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 to enter the body during keyhole surgery. The 946 reports mostly describe its balloon not inflating or fully filling with air, breaking during procedures, and parts detaching. The reports include no deaths and 10 injuries. There is 1 recall, still open, started in February 2024, about the seal possibly coming loose when mesh products are used incorrectly with the device. Reports fell to 40 over the last year from 98 in the year before.
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
- 955
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 955 adverse event reports that list this exact device (DI 10884521080874), received between Sep 20, 2016 and Sep 30, 2026 — classified as 10 injuries, 945 malfunctions.
The most frequently reported specific device problem is “Inflation Problem” (470 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.
Reports received per month
Recalls naming this device
- Feb 28, 2024Class IIOpen, Classified
The potential for trocar seal disengagement when using mesh products incorrectly with the device.
Z-1470-2024 · Root cause: Labeling design · Recall details · FDA record ↗
Most reported problems
Device problems
- Inflation Problem470
- Break366
- Detachment of Device or Device Component92
- Gas/Air Leak44
- Leak/Splash29
- Material Split, Cut or Torn27
- Detachment Of Device Component21
- Packaging Problem21
Patient problems
- No Clinical Signs, Symptoms or Conditions467
- No Known Impact Or Consequence To Patient248
- No Consequences Or Impact To Patient119
- No Patient Involvement76
- Insufficient Information74
- Foreign Body In Patient6
- No Information5
- Device Embedded In Tissue or Plaque3
Recent adverse event reports
The 25 most recent of 955 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952654 ↗MalfunctionSep 28, 2026Inflation Problem
Patient problems: Insufficient Information
MAUDE report 50926231 ↗MalfunctionSep 22, 2026Break; Noise, Audible
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859037 ↗MalfunctionSep 22, 2026Break; Noise, Audible
According to the reporter, during a laparoscopic surgery, upon inflating the balloon following insertion into the abdomen, while using the first balloon and the surgeon was putting 25 mls air, it worked for less than 10 minutes then a muffled pop was heard and it leaked. The balloon was pulled out from the trocar and the balloon had popped. A new balloon was opened and another muffled pop washeard. The balloon had popped as well. A third balloon was used to resolve the issue. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50859005 ↗MalfunctionSep 18, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820405 ↗MalfunctionSep 16, 2026Inflation Problem
According to the reporter, during a procedure, the balloon did not inflate.
Patient problems: Insufficient Information
MAUDE report 50788449 ↗MalfunctionSep 15, 2026Inflation Problem
It was reported that during a procedure, the balloon did not inflate.
Patient problems: Insufficient Information
MAUDE report 50767064 ↗MalfunctionSep 14, 2026Inflation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50764158 ↗MalfunctionSep 11, 2026Inflation Problem
It was reported that during a procedure, the balloon did not inflate.
Patient problems: Insufficient Information
MAUDE report 50732881 ↗MalfunctionAug 10, 2026Break
According to the reporter, during a procedure, the balloon physically broke. Another device was used to complete the procedure. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50192849 ↗MalfunctionAug 10, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50192704 ↗MalfunctionJun 23, 2026Inflation Problem
ACCORDING TO THE REPORTER, INTRAOPERATIVELY, DURING USE, AIR DID NOT FULLY FILL THE BALLOON.
Patient problems: Insufficient Information
MAUDE report 25596152 ↗MalfunctionApr 27, 2026Inflation Problem
IT WAS REPORTED THAT THE BALLOON DID NOT INFLATE. A NEW DEVICE WAS APPLIED TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 25002608 ↗MalfunctionApr 1, 2026Inflation Problem
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SURGERY, THE BALLOON DEFLATED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24753312 ↗MalfunctionApr 1, 2026Inflation Problem
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC 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 24753282 ↗MalfunctionApr 1, 2026Break; Gas/Air Leak
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SURGERY, THE BALLOON LEAKED AIR. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24753247 ↗MalfunctionMar 30, 2026Inflation Problem
IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, AN ACCESS BALLOON DID NOT INFLATE. THE DEVICE WAS EXCHANGED FOR A NEW PRODUCT 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 24734364 ↗MalfunctionMar 30, 2026Inflation Problem
IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE BALLOON DID NOT INFLATE. THE DEVICE WAS EXCHANGED FOR A NEW PRODUCT TO RESOLVE THE ISSUE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24729761 ↗MalfunctionMar 30, 2026Inflation Problem
IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE BALLOON DID NOT INSUFFLATE. THE PRODUCT WAS EXCHANGED FOR A NEW PRODUCT 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 24728213 ↗MalfunctionMar 11, 2026Inflation Problem
ACCORDING TO THE REPORTER, DURING A BALLOON TEST BEFORE PROCEDURE, THE BALLOON DID NOT SWELL UP. A NEW BALLOON WAS USED TO RESOLVE THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24572058 ↗MalfunctionMar 3, 2026Leak/Splash; Decrease in Pressure
IT WAS REPORTED THAT DURING A LAPAROSCOPIC HERNIA PROCEDURE, WHEN INSERTING THE TROCAR, A RAPID LOSS OF PNEUMOPERITONEUM LEAKAGE. TO RESOLVE THE ISSUE, A NEW TROCAR WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24500813 ↗MalfunctionFeb 24, 2026Inflation Problem
IT WAS REPORTED THAT DURING A LAPAROSCOPIC INGUINAL HERNIA PROCEDURE AT THE DISSECTION STEP, THE BALLOON DID NOT INFLATE. THE ISSUE WAS RESOLVED BY USING ANOTHER DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24428785 ↗MalfunctionFeb 18, 2026Inflation Problem; Difficult to Insert
IT WAS REPORTED THAT DURING THE LAPAROSCOPIC TOTALLY EXTRAPERITONEAL INGUINAL HERNIA REPAIR, THE BALLOON DID NOT INSUFFLATE EASILY AND SLIPPED OUT A NUMBER OF TIMES WHILE ATTEMPTING TO INSERT AND INFLATE DURING THE ACCESS STEP. . AN ALTERNATIVE TROCAR WAS USED BY THE SURGEON 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 24381225 ↗MalfunctionJan 16, 2026Break
ACCORDING TO THE REPORTER, THE BALLOON POPPED.
Patient problems: Insufficient Information
MAUDE report 24091247 ↗MalfunctionJan 13, 2026Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A LAPAROSCOPIC PROCEDURE, THE BALLOON PHYSICALLY RUPTURED. A BALLOON FRAGMENT CAME OUT OF THE PORT INSERTION SITE DURING WOUND CLOSURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24059659 ↗
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-1466-2024 · Feb 28, 2024 · Open, ClassifiedCovidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNL
- Z-1467-2024 · Feb 28, 2024 · Open, ClassifiedCovidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSNL
- Z-1465-2024 · Feb 28, 2024 · Open, ClassifiedCovidien Auto Suture" Structural Balloon Trocar, Product Number OMS-T10SB
- Z-1469-2024 · Feb 28, 2024 · Open, ClassifiedCovidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTS
- Z-1471-2024 · Feb 28, 2024 · Open, ClassifiedCovidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTNL
- Z-1468-2024 · Feb 28, 2024 · Open, ClassifiedCovidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BT
Other Laparoscope, general & plastic surgery devices
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- Auto Suture OMS-T10SBCovidien LP · Laparoscope, general & plastic surgery1 recall697 reports
- Spacemaker SMBTTRNDXCovidien LP · Laparoscope, general & plastic surgery590 reports
- VISERA VIDEO SYSTEM CENTER OTV-S7V CAMERA HEAD OTV-S7H-1D-L08EOlympus Medical Systems Corp. · Laparoscope, general & plastic surgery578 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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