VersaportRecalls & reported problems across all models
Covidien LP · 21 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 532
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls
- 0
We found 21 models of Versaport by Covidien LP in the FDA's device registry (GUDID). Together they are named in 532 adverse event reports in the FDA's MAUDE database, received between Jun 13, 2016 and Aug 31, 2026 — classified as 16 injuries, 516 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (267 reports).
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
Most reported Versaport problems
Device problems
- Material Split, Cut or Torn267
- Leak/Splash255
- Packaging Problem92
- Detachment of Device or Device Component71
- Decrease in Pressure52
- Noise, Audible44
- Break42
- Device Packaging Compromised29
Patient problems
- No Clinical Signs, Symptoms or Conditions370
- No Known Impact Or Consequence To Patient86
- No Consequences Or Impact To Patient49
- Insufficient Information25
- No Code Available11
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Foreign Body In Patient2
- Tissue Breakdown2
Versaport models
21 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Versaport UNVCA12STFLaparoscope, general & plastic surgery373 reports
- Versaport ONB5SHFLaparoscope, general & plastic surgery48 reports
- Versaport ONB5STFLaparoscope, general & plastic surgery44 reports
- Versaport ONB12SHFLaparoscope, general & plastic surgery21 reports
- Versaport 179094FLaparoscope, general & plastic surgery10 reports
- Versaport NB5STFLaparoscope, general & plastic surgery7 reports
- Versaport ONB11STFLaparoscope, general & plastic surgery5 reports
- Versaport UNVCA11STFLaparoscope, General & Plastic Surgery5 reports
- Versaport ONBFCA12STLaparoscope, general & plastic surgery4 reports
- Versaport ONB5LGFLaparoscope, general & plastic surgery3 reports
- Versaport ONB11LGFLaparoscope, general & plastic surgery2 reports
- Versaport NB3SHFLPLaparoscope, general & plastic surgery1 report
- Versaport 177772Laparoscope, general & plastic surgery1 report
- Versaport 177794Laparoscope, general & plastic surgery1 report
- Versaport ONB5STF2CLaparoscope, general & plastic surgery1 report
- Versaport 177798Laparoscope, general & plastic surgery1 report
- Versaport UNVCA12LGFLaparoscope, General & Plastic Surgery1 report
- Versaport 179093FLaparoscope, general & plastic surgery1 report
- Versaport 179094Laparoscope, general & plastic surgery1 report
- Versaport 179101Laparoscope, general & plastic surgery1 report
- Versaport 177092FLaparoscope, general & plastic surgery1 report
Recent Versaport adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionAug 31, 2026Leak/Splash; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50516411 ↗MalfunctionAug 31, 2026Leak/Splash; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50516390 ↗MalfunctionAug 4, 2026Material Split, Cut or Torn
It was reported that during a laparoscopic procedure, the seal was damaged on twelve cannulas. To resolve the issue and complete the case, the cannula was removed. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50129090 ↗MalfunctionAug 4, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50129046 ↗MalfunctionAug 4, 2026Material Split, Cut or Torn
It was reported that during a laparoscopic procedure, the seal was damaged on twelve cannulas. To resolve the issue and complete the case, the cannula was removed. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50128987 ↗MalfunctionAug 4, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50128763 ↗MalfunctionAug 4, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50128730 ↗MalfunctionAug 4, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50128650 ↗MalfunctionAug 4, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50128521 ↗MalfunctionJul 31, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50107764 ↗MalfunctionMay 19, 2026Leak/Splash; Material Split, Cut or Torn
IT WAS REPORTED THAT DURING A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, A GAS WAS OBSERVED ESCAPING THROUGH THE TROCAR VALVE AT THE START OF SURGERY. THE VALVE ON THE CANNULA JACKET WAS REPORTED TO BE DAMAGED AND LEAKING GAS. THE TROCAR SLEEVE WAS REPLACED WITH ANOTHER SLEEVE FROM THE SAME BATCH. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25216219 ↗InjuryApr 20, 2026Melted; Environmental Particulates
IT WAS REPORTED THAT DURING A LAPAROSCOPIC SURGICAL PROCEDURE, AT THE BEGINNING OF THE SURGERY AND DURING THE LAPAROSCOPY PROCESS USING THE ENERGY PLATFORM AND A NON-MEDTRONIC MONOPOLAR SPATULA, THE ENERGY WAS INITIALLY SET AT 20W FOR PURE CUT AND COAGULATION AND WAS THEN INCREASED TO 30W DUE TO INSUFFICIENT TISSUE EFFECT, AFTER WHICH A MATCH-SIZED FLAME OCCURRED AT THE NON-MEDTRONIC MONOPOLAR INSTRUMENT UPON ACTIVATION VIA THE MONOPOLAR FOOT SWITCH. THE DEVICE ALSO CAUGHT ON FIRE. THE MONOPOLAR INSTRUMENT WAS IMMEDIATELY WITHDRAWN FROM THE PATIENT¿S CAVITY AND DISCONTINUED, AND A DEVICE WAS INTRODUCED; UPON ACTIVATING DEVICE ENERGY INSIDE THE PATIENT¿S CAVITY, AN ENERGY OVERLOAD WAS REPORTED AND THERMAL DAMAGE (BURNING) TO THE SURGICAL CANNULA OCCURRED. THE DEVICE WAS ACTIVATED MULTIPLE TIMES IN SUCCESSION JUST PRIOR TO THE BURN. AN EXPLORATORY LAPAROSCOPIC INSPECTION OF THE ABDOMINAL CAVITY IDENTIFIED THERMAL LESIONS (BURN) ON THE ABDOMINAL WALL WITH ASSOCIATED TISSUE DAMAGE OR UNEXPECTED TISSUE LOSS, AND MELTED POLYMER DEBRIS INSIDE THE ABDOMINAL CAVITY THAT WAS REPORTED TO ORIGINATE FROM THE STRUCTURALLY COMPROMISED CANNULA. THE BURN WAS LOCATED AROUND THE TROCAR AND IN A REGIO
Patient problems: Laceration(s)
MAUDE report 24925167 ↗MalfunctionMar 26, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A LAPAROSCOPIC APPENDECTOMY IN THE ABDOMEN, THE DUCKBILL SEAL WAS DISLODGED. NO COMPONENT FELL INTO THE CAVITY OF THE PATIENT. A NEW DEVICE WAS USED 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 24696728 ↗MalfunctionMar 16, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT DURING ENTRY OF THE ABDOMEN IN A LAPAROSCOPIC GASTRIC BYPASS PROCEDURE, THE SEAL OF THE DEVICE WAS DAMAGED AND AN AIR LEAK OCCURRED. 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 24605815 ↗MalfunctionFeb 17, 2026Leak/Splash; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SURGERY WITH ROBOT-ASSISTED LIVER RESECTION, THE DEVICE SEAL WAS DAMAGED RESULTING IN PNEUMOPERITONEUM AIR/GAS LEAKAGE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24361707 ↗
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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