Versaport PlusRecalls & reported problems across all models
Covidien LP · 15 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 155
- Deaths reported
- 1
- Injuries reported
- 8
- Recalls
- 0
We found 15 models of Versaport Plus by Covidien LP in the FDA's device registry (GUDID). Together they are named in 155 adverse event reports in the FDA's MAUDE database, received between Nov 24, 2015 and Jun 11, 2026 — classified as 1 death, 8 injuries, 146 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (55 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 Plus problems
Device problems
- Detachment of Device or Device Component55
- Packaging Problem38
- Break33
- Detachment Of Device Component28
- Material Split, Cut or Torn15
- Difficult to Insert12
- Leak/Splash12
- Device Packaging Compromised3
Patient problems
- No Known Impact Or Consequence To Patient56
- No Clinical Signs, Symptoms or Conditions45
- No Consequences Or Impact To Patient39
- No Patient Involvement6
- No Code Available5
- Insufficient Information3
- No Information3
- Tissue Damage3
Versaport Plus models
15 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Versaport Plus NB15STFLaparoscope, general & plastic surgery43 reports
- Versaport Plus 179078PLaparoscope, general & plastic surgery27 reports
- Versaport Plus 179078PFLaparoscope, general & plastic surgery1 death22 reports
- Versaport Plus NB12STFLaparoscope, general & plastic surgery18 reports
- Versaport Plus 179096PFLaparoscope, general & plastic surgery14 reports
- Versaport Plus NB15LGFLaparoscope, general & plastic surgery9 reports
- Versaport Plus 177091PFLaparoscope, general & plastic surgery5 reports
- Versaport Plus NB8STFLaparoscope, general & plastic surgery3 reports
- Versaport Plus NB11STFLaparoscope, general & plastic surgery3 reports
- Versaport Plus 179095PLaparoscope, general & plastic surgery3 reports
- Versaport Plus 179103PLaparoscope, general & plastic surgery3 reports
- Versaport Plus 179095PFLaparoscope, general & plastic surgery2 reports
- Versaport Plus 179096PLaparoscope, general & plastic surgery1 report
- Versaport Plus 177090PFLaparoscope, general & plastic surgery1 report
- Versaport Plus 177995PLaparoscope, general & plastic surgery1 report
Recent Versaport Plus adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJun 11, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT DURING A LAPAROSCOPIC SLEEVE PROCEDURE AT INSERTION, THE DEVICE HAD A DAMAGED SEAL. THE TROCAR 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 25467321 ↗MalfunctionMar 6, 2026Break
IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE BALLOON BURST. THE ISSUE WAS RESOLVED BY USING A NEW PRODUCT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24528757 ↗MalfunctionNov 5, 2025Difficult to Insert; Leak/Splash; Difficult to Insert; Leak/Splash
ACCORDING TO THE CLINICAL STUDY, INTRA-OPERATIVELY, WHEN THE INSTRUMENTS WERE INTRODUCED THROUGH THE TROCAR, GAS LEAKS WERE NOTICED. THE JOINT WAS STUCK IN THE DEVICE AND NOT WATERPROOF, LEADING TO GAS LOSSES AND THE LOSS OF PNEUMOPERITONEUM. THE PROCEDURE WAS EXTENDED DUE TO THE ISSUE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23476659 ↗MalfunctionNov 21, 2024Break; Retraction Problem; Break; Retraction Problem
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, AT THE BEGINNING OF THE PROCEDURE, WHEN THE USER WAS TRYING TO ACTIVATE THE TROCAR, THE TROCAR WAS DAMAGED AND THE BLADE DID NOT LOWER, THE SCRUB NURSE MADE SEVERAL ATTEMPTS BUT IT DID NOT WORK. ANOTHER TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20745552 ↗MalfunctionOct 10, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, PREOPERATIVELY, THE SEAL WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20419329 ↗MalfunctionAug 21, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VERTICAL GASTRECTOMY, AFTER FIRING A RELOAD, THE SEAL WAS DAMAGED. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20020119 ↗MalfunctionJun 17, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE THE TROCAR SEAL WAS DAMAGED, THERE WERE ALSO TWO RELOADS REPORTED TO HAVE MALFUNCTIONED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19547880 ↗MalfunctionMay 10, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN A DISPOSABLE BLADELESS PUNCTURE APPARATUS WAS USED TO MAKE A HOLE, THE INTERFACE OF THE PUNCTURE WAS BROKEN AND THE SURGERY COULD NOT BE PERFORMED. THE DEVICE WAS REPLACED WITH A NEW PUNCTURE APPARATUS IMMEDIATELY, THE SURGERY CONTINUED, AND THE PATIENT RETURNED TO THE WARD SAFELY. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19288682 ↗MalfunctionMay 1, 2024Break; Break
ACCORDING TO THE REPORTER, PRIOR TO LOBECTOMY, JUST UNPACKED AND HAD NOT BEEN INSERTED INTO THE BODY YET, THE INNER CORE WAS PUNCTURED. THE USER REPLACED THE SHEATH CARD FOR PUNCTURE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19220833 ↗MalfunctionApr 3, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, WHEN THE CLIP APPLIER WAS INSERTED, WHEN IT WAS EXTRACTED IT COMES OUT WITH REMAINS OF THE SEAL. TO RESOLVE THE ISSUE, THE SEAL REMAINS WAS REMOVED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19033627 ↗MalfunctionMar 7, 2024Break; Break
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC SLEEVE GASTRECTOMY PROCEDURE, UPON INTRODUCTION OF TROCAR INTO PATIENT, THE TROCAR BROKE. ANOTHER TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18860458 ↗MalfunctionFeb 7, 2024Break; Difficult to Insert; Break; Difficult to Insert
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC SLEEVE, WHEN MOUNTING THE PUNCH IN THE CANNULA, IT GOT STUCK. THE SURGEON TRIED TO INSERT THE PUNCH BUT IT DID NOT ADVANCE. THE SURGEON THEN REMOVED THE TROCAR AND WHILE REMOVING IT, THE TROCAR BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18661600 ↗MalfunctionDec 14, 2023Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHEN THE DOCTOR WAS PERFORMING A KIDNEY TRANSPLANT, THERE WAS AN AIR OR GAS LEAKED FROM THE SEAL, THE TROCAR MEMBRANE RUPTURE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18332095 ↗MalfunctionDec 6, 2023Difficult to Remove; Difficult to Remove
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHEN THE SURGEON PLACED THE DEVICE IN THE TROCAR, IT GOT STUCK IN THE MIDDLE, IT DID NOT GO THROUGH THE SEAL. ANOTHER TROCAR WAS USED, THE DEVICE STILL DID NOT PASS THROUGH. A NEW TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18278617 ↗MalfunctionDec 6, 2023Difficult to Remove; Difficult to Remove
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHEN THE SURGEON PLACED THE DEVICE IN THE TROCAR, IT GOT STUCK IN THE MIDDLE, IT DID NOT GO THROUGH THE SEAL. ANOTHER TROCAR WAS USED, THE DEVICE STILL DID NOT PASS THROUGH. A NEW TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18278456 ↗
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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