VersaOneRecalls & reported problems across all models
Covidien LP · 47 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
3 open recalls name at least one VersaOne model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2,215
- Deaths reported
- 4
- Injuries reported
- 114
- Recalls
- 3
We found 47 models of VersaOne by Covidien LP in the FDA's device registry (GUDID). Together they are named in 2,215 adverse event reports in the FDA's MAUDE database, received between Jul 11, 2016 and Sep 29, 2026 — classified as 4 deaths, 114 injuries, 2,097 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (754 reports).
3 FDA recall records name at least one of these models by its device identifier, 3 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
VersaOne 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.
- Mar 22, 2023Open, Classified
There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the VersaOneTM Reusable Positioning Cannula, located where the Cannula and Body components are welded together.
Z-1465-2023 · Root cause: Process control · Recall details · FDA record ↗
- Mar 22, 2023Open, Classified
There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the VersaOneTM Reusable Positioning Cannula, located where the Cannula and Body components are welded together.
Z-1464-2023 · Root cause: Process control · Recall details · FDA record ↗
- Mar 22, 2023Open, Classified
There is a manufacturing non-conformance that may result in a metal shaving (burr) on the inside of the VersaOneTM Reusable Positioning Cannula, located where the Cannula and Body components are welded together.
Z-1463-2023 · Root cause: Process control · Recall details · FDA record ↗
Most reported VersaOne problems
Device problems
- Leak/Splash754
- Detachment of Device or Device Component657
- Material Split, Cut or Torn620
- Packaging Problem503
- Break373
- Difficult to Insert166
- Decrease in Pressure134
- Difficult to Remove108
Patient problems
- No Clinical Signs, Symptoms or Conditions1,219
- No Consequences Or Impact To Patient365
- No Known Impact Or Consequence To Patient356
- Insufficient Information110
- No Patient Involvement74
- Foreign Body In Patient45
- No Code Available30
- No Information30
VersaOne models
47 models, most reported first. Each model has its own page with its reports, recalls and device details.
- VersaOne ONB12STFLaparoscope, general & plastic surgery531 reports
- VersaOne B12STFLaparoscope, General & Plastic Surgery2 deaths180 reports
- VersaOne ONB15STFLaparoscope, general & plastic surgery174 reports
- VersaOne BPT12STSLaparoscope, general & plastic surgery159 reports
- VersaOne ONB5STFLaparoscope, general & plastic surgery1 death143 reports
- VersaOne NONB12STFLaparoscope, general & plastic surgery129 reports
- VersaOne UNVCA5STFLaparoscope, General & Plastic Surgery76 reports
- VersaOne RNONB8STFLaparoscope, general & plastic surgery73 reports
- VersaOne ONB11STFLaparoscope, general & plastic surgery72 reports
- VersaOne ONB12STFLaparoscope, general & plastic surgery70 reports
- VersaOne ONB5SHFLaparoscope, general & plastic surgery65 reports
- VersaOne B11STFLaparoscope, general & plastic surgery1 death55 reports
- VersaOne RC8STSLaparoscope, general & plastic surgery1 recall2 reports
- VersaOne RC11STSLaparoscope, general & plastic surgery1 recall1 report
- VersaOne RC12STSLaparoscope, general & plastic surgery1 recall0 reports
- VersaOne NONB15STFLaparoscope, general & plastic surgery49 reports
- VersaOne BPT12STSLaparoscope, general & plastic surgery47 reports
- VersaOne B5STFLaparoscope, general & plastic surgery42 reports
- VersaOne NONB5STFLaparoscope, general & plastic surgery36 reports
- VersaOne ONB12SHFLaparoscope, general & plastic surgery36 reports
- VersaOne NONB15LGFLaparoscope, general & plastic surgery30 reports
- VersaOne ONB12STFCSLaparoscope, general & plastic surgery29 reports
- VersaOne NONB11STFLaparoscope, general & plastic surgery26 reports
- VersaOne NONB8STFLaparoscope, general & plastic surgery25 reports
- VersaOne ONB5STBLaparoscope, general & plastic surgery21 reports
- VersaOne RSEALLaparoscope, general & plastic surgery19 reports
- VersaOne UNVCA5SHFLaparoscope, General & Plastic Surgery17 reports
- VersaOne NONB5SHFLaparoscope, general & plastic surgery12 reports
- VersaOne RONB11STFLaparoscope, general & plastic surgery11 reports
- VersaOne NONB12SHFLaparoscope, general & plastic surgery9 reports
- VersaOne B5SHFLaparoscope, general & plastic surgery7 reports
- VersaOne NONB12LGFLaparoscope, general & plastic surgery7 reports
- VersaOne ONB5STF2CLaparoscope, general & plastic surgery7 reports
- VersaOne ONB12LGFLaparoscope, general & plastic surgery7 reports
- VersaOne RUNVCA8STFLaparoscope, general & plastic surgery7 reports
- VersaOne UNVCA5STBLaparoscope, general & plastic surgery6 reports
- VersaOne B11STSLaparoscope, general & plastic surgery5 reports
- VersaOne B12STSLaparoscope, general & plastic surgery5 reports
- VersaOne FCSPASSLaparoscope, general & plastic surgery5 reports
- VersaOne B5SHSLaparoscope, general & plastic surgery4 reports
- VersaOne B5STSLaparoscope, general & plastic surgery4 reports
- VersaOne B12LGFLaparoscope, general & plastic surgery4 reports
- VersaOne ONB12LGFLaparoscope, general & plastic surgery2 reports
- VersaOne NONB12STSLaparoscope, general & plastic surgery2 reports
- VersaOne ONB5LGFLaparoscope, general & plastic surgery2 reports
- VersaOne ONB12STSLaparoscope, general & plastic surgery1 report
- VersaOne FCSPASSLaparoscope, general & plastic surgery1 report
Recent VersaOne adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Difficult to Insert; Leak/Splash; Detachment of Device or Device Component
According to the reporter, during a laparoscopic sleeve gastrectomy procedure using a trocar, while the surgeon was stapling the stomach, resistance was encountered when inserting a stapling device through the trocar. The surgeon had to remove the stapler and align it better with the trocar. During firing, the surgeon observed a loss of pressure in the abdominal space. The surgeon placed a finger over the trocar opening to maintain normal peritoneal pressure. Upon investigation, the trocar seal was found to have become dislodged and fallen into the patient¿s abdominal cavity. The dislodged seal was visualized intraoperatively, retrieved using a grasper, and removed through the trocar. The procedure was completed successfully with no reported patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934713 ↗MalfunctionSep 24, 2026Material Split, Cut or Torn
According to the reporter, the device seal ruptured during the procedure while in use on the patient.
Patient problems: Insufficient Information
MAUDE report 50883990 ↗MalfunctionSep 22, 2026Protective Measures Problem
It was reported that during a surgical procedure, the retractable blade mechanism failed to function as expected during insertion, resulting in gastric perforation.
Patient problems: Perforation
MAUDE report 50855076 ↗InjurySep 8, 2026Detachment of Device or Device Component
Patient problems: Foreign Body In Patient
MAUDE report 50677503 ↗MalfunctionAug 28, 2026Leak/Splash; Material Split, Cut or Torn
According to the reporter, during a laparoscopic colon lowering, it was observed that the sealing mechanism of the 11 mm disposable trocar failed, making it impossible to maintain the pneumoperitoneum due to recurrent air leakage. Another trocar of the same brandwas exchanged to resolve the issue after making more than three attempts. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50495241 ↗MalfunctionAug 24, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50421577 ↗MalfunctionAug 24, 2026Break; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50420506 ↗MalfunctionAug 18, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50312249 ↗MalfunctionAug 18, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50299888 ↗MalfunctionAug 11, 2026Break
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 50201363 ↗MalfunctionAug 10, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50193309 ↗MalfunctionAug 7, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50175207 ↗MalfunctionAug 7, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50175046 ↗InjuryAug 6, 2026Detachment of Device or Device Component
It was reported that during a laparoscopic cholecystectomy, when the physician went to access the abdominal cavity and when passing the clipper by the trocar, the top part of the trocar, the sealing membrane, came loose and fell into the cavity. The device was replaced to resolve the issue.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 50161030 ↗MalfunctionAug 6, 2026Leak/Splash; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50151353 ↗
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.
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