Multifire VersaTackRecalls & reported problems across all models
Covidien LP · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 90
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 2 models of Multifire VersaTack by Covidien LP in the FDA's device registry (GUDID). Together they are named in 90 adverse event reports in the FDA's MAUDE database, received between Jun 19, 2017 and May 27, 2026 — classified as 90 malfunctions.
The most frequently reported specific device problem is “Failure to Fire” (37 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 Multifire VersaTack problems
Device problems
- Failure to Fire37
- Failure to Form Staple14
- Mechanical Jam12
- Break11
- Insufficient Device Problem Information11
- Mechanics Altered8
- Loss of or Failure to Bond6
- Misfire5
Patient problems
- No Known Impact Or Consequence To Patient39
- No Clinical Signs, Symptoms or Conditions36
- No Consequences Or Impact To Patient9
- Insufficient Information5
- No Information3
- No Patient Involvement2
- Foreign Body In Patient1
- Hematoma1
Multifire VersaTack models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Multifire VersaTack 174023Laparoscope, general & plastic surgery64 reports
- Multifire VersaTack 174021Laparoscope, general & plastic surgery26 reports
Recent Multifire VersaTack adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 27, 2026Adverse Event Without Identified Device or Use Problem
ACCORDING TO THE REPORTER, THE PATIENT HAD A HEMATOMA IN THE RIGHT TESTICLE AND SIGNIFICANT PAIN IN THE ON THE SAME SIDE. THE PATIENT WAS OPERATED ON (B)(6) 2024, AND SINCE THEN, THE PATIENT WAS EXPERIENCING STABBING SENSATIONS AND PAIN WHILE WALKING WHICH WERE VERY DISABLING.
Patient problems: Hematoma; Pain
MAUDE report 25298828 ↗MalfunctionFeb 24, 2025Product Quality Problem; Failure to Fire; Product Quality Problem; Failure to Fire
ACCORDING TO THE REPORTER, IN AN OPEN HERNIA REPAIR, NO TACKS WERE ABLE TO BE FIRED NORMALLY FROM THE DEVICE. THERE WAS A NOTICEABLE GAP BETWEEN THE TWO PARTS OF THE TIP OF THE TACKER. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21447463 ↗MalfunctionJul 25, 2024Break; Failure to Fire; Break; Failure to Fire
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE STAPLES WERE NOT ABLE TO BE FIRED FROM THE DEVICE. ADDITIONALLY, THE HANDLE BROKE. TO RESOLVE THE ISSUE, ANOTHER STAPLER WAS USED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19830769 ↗MalfunctionApr 9, 2024Break; Break
ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE DEVICE WAS DEFECTIVE AT THE TIME OF STAPLING; CLAMPING WAS FAULTY DURING GRAFT. THE TIP BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. IT WAS REPORTED THAT THERE WAS A DELAY IN THE SURGICAL PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19074025 ↗MalfunctionDec 27, 2023Failure to Form Staple; Failure to Form Staple
ACCORDING TO THE REPORTER, DURING A LEFT INGUINAL HERNIA REPAIR WITH MESH, WHEN DEPRESSING THE TRIGGER, THE STAPLE WOULD RELEASE BUT THE STAPLES DID NOT CLOSED FULLY. ATTEMPTED TO USE WITH A NEW LOAD BUT SAME ISSUE OCCURRED. A NEW HERNIA STAPLER WAS USED TO RESOLVE THE ISSUE.
Patient problems: Tissue Breakdown
MAUDE report 18402192 ↗MalfunctionApr 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A PROCEDURE, A PLASTIC TAB AT THE END OF THE CLAMP HAD DISLODGED IN INTRA-ABDOMINAL AND WAS NO LONGER FUNCTIONAL. NO DEVICE COMPONENT FELL INTO THE CAVITY OF THE PATIENT. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions
MAUDE report 16797970 ↗MalfunctionApr 19, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING OPEN HERNIA SURGERY, WHEN HOLDING THE CLAMP, THE CLAMP DISENGAGED. ANOTHER TACKER WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16771400 ↗MalfunctionJan 20, 2023Failure to Form Staple; Failure to Form Staple
ACCORDING TO THE REPORTER, DURING OPEN SURGERY FOR DIRECT ACCESS INGUINAL HERNIA, THE STAPLES DID NOT CLOSE PROPERLY ON THE MESH. NO COMPONENT FELL INTO PATIENT CAVITY. THE MESH WAS FIXED WITH A SUTURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16214008 ↗MalfunctionOct 18, 2022Break; Break
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA PROCEDURE, WHEN TRYING TO RELOAD THE STAPLER, THE PIECE AT END WAS BROKE. OPENED A NEW DEVICE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15621162 ↗MalfunctionSep 24, 2022Break; Break
ACCORDING TO THE REPORTER, DURING A CELIO PROCEDURE BEFORE USING THE DEVICE ON THE PATIENT, THE DEVICE PHYSICALLY BROKE AND DID NOT WORK AS SOON AS IT WAS ACTIVATED. NO TACKS WERE ABLE TO BE FIRED FROM THE DEVICE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15479441 ↗MalfunctionSep 14, 2022Break; Failure to Fire; Break; Failure to Fire
ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE CLEAR END TIP OF THE TWO STAPLERS WERE BROKEN, BOTH DEVICES WERE NOT ABLE TO FIRE NORMALLY. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15421675 ↗MalfunctionSep 14, 2022Break; Failure to Fire; Break; Failure to Fire
ACCORDING TO THE REPORTER, THE CLEAR END TIP OF THE 2 STAPLERS WERE BROKEN DURING THEIR USE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15421535 ↗MalfunctionSep 7, 2022Failure to Fire; Insufficient Device Problem Information; Failure to Fire; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL PROCEDURE, WHILE TACKING MESH, THE DEVICE JAMMED AND WOULD NOT FIRE. ANOTHER DEVICE WAS OPENED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15374792 ↗MalfunctionSep 7, 2022Failure to Fire; Insufficient Device Problem Information; Failure to Fire; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL PROCEDURE, WHILE TACKING MESH, THE DEVICE JAMMED AND WOULD NOT FIRE. ANOTHER DEVICE WAS OPENED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15374768 ↗MalfunctionSep 7, 2022Failure to Fire; Insufficient Device Problem Information; Failure to Fire; Insufficient Device Problem Information
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL PROCEDURE, WHILE TACKING MESH, THE DEVICE JAMMED AND WOULD NOT FIRE. ANOTHER DEVICE WAS OPENED TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15374707 ↗
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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