Auto SutureRecalls & reported problems across all models
Covidien LP · 10 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
7 open recalls name at least one Auto Suture model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2,573
- Deaths reported
- 0
- Injuries reported
- 44
- Recalls
- 7
We found 10 models of Auto Suture by Covidien LP in the FDA's device registry (GUDID). Together they are named in 2,573 adverse event reports in the FDA's MAUDE database, received between Sep 6, 2016 and Sep 30, 2026 — classified as 44 injuries, 2,529 malfunctions.
The most frequently reported specific device problem is “Inflation Problem” (996 reports).
7 FDA recall records name at least one of these models by its device identifier, 7 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Auto Suture recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- 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 · Recall details · FDA record ↗
- Feb 28, 2024Open, 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 ↗
- Feb 28, 2024Open, 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 ↗
- Feb 28, 2024Open, 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 ↗
- Feb 28, 2024Open, Classified
The potential for trocar seal disengagement when using mesh products incorrectly with the device.
Z-1467-2024 · Root cause: Labeling design · Recall details · FDA record ↗
- Feb 28, 2024Open, Classified
The potential for trocar seal disengagement when using mesh products incorrectly with the device.
Z-1466-2024 · Root cause: Labeling design · Recall details · FDA record ↗
- Feb 28, 2024Open, 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 Auto Suture problems
Device problems
- Inflation Problem996
- Break844
- Detachment of Device or Device Component751
- Decrease in Pressure122
- Leak/Splash120
- Material Split, Cut or Torn118
- Gas/Air Leak92
- Detachment Of Device Component74
Patient problems
- No Clinical Signs, Symptoms or Conditions1,433
- No Known Impact Or Consequence To Patient544
- No Consequences Or Impact To Patient300
- Insufficient Information199
- No Patient Involvement116
- No Information31
- Foreign Body In Patient27
- No Code Available20
Auto Suture models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Auto Suture OMS-T10BTLaparoscope, general & plastic surgery1 recall955 reports
- Auto Suture OMS-T10SBLaparoscope, general & plastic surgery1 recall697 reports
- Auto Suture OMS-T12BTLaparoscope, general & plastic surgery1 recall475 reports
- Auto Suture OMS-T10BTNLLaparoscope, general & plastic surgery1 recall218 reports
- Auto Suture 24055Laparoscope, general & plastic surgery119 reports
- Auto Suture OMST12BTNLLaparoscope, general & plastic surgery1 recall60 reports
- Auto Suture OMS-T10BTSLaparoscope, general & plastic surgery1 recall35 reports
- Auto Suture OMST10BTSNLLaparoscope, general & plastic surgery1 recall3 reports
- Auto Suture 150462STAPLE, REMOVABLE (SKIN)10 reports
- Auto Suture 4216Laparoscope, general & plastic surgery1 report
Recent Auto Suture adverse event reports
The 15 most recent reports across all models, 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 30, 2026Detachment of Device or Device Component; Material Split, Cut or Torn
It was reported that during a laparoscopic hysterectomy, two trocars had a damaged seal. Part of the plastic opening inside the port fell into the patient¿s cavity. Several minutes of medical or surgical intervention were needed to prevent permanent impairment of function, and another trocar was opened 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 50941666 ↗MalfunctionSep 29, 2026Detachment of Device or Device Component; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936626 ↗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; Leak/Splash
Patient problems: Insufficient Information
MAUDE report 50829152 ↗MalfunctionSep 18, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50820405 ↗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, 2026Inflation Problem
According to the reporter, during a procedure, the balloon did not inflate.
Patient problems: Insufficient Information
MAUDE report 50788449 ↗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 15, 2026Inflation Problem
It was reported that during a procedure, the balloon did not inflate.
Patient problems: Insufficient Information
MAUDE report 50767064 ↗
Other Covidien LP products
- Endo GIA48 models · 26,277 reports · 8 recalls
- Endo GIA Ultra3 models · 15,650 reports
- Shiley387 models · 9,392 reports · 5 recalls
- Signia16 models · 8,201 reports · 6 recalls
- LigaSure32 models · 7,283 reports · 1 recall
- Tri-Staple 2.037 models · 4,892 reports · 2 recalls
- Polysorb291 models · 4,564 reports · 2 recalls
- EEA39 models · 4,432 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page