Multifire Endo HerniaRecalls & reported problems across all models
Covidien LP · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 243
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls
- 0
We found 4 models of Multifire Endo Hernia by Covidien LP in the FDA's device registry (GUDID). Together they are named in 243 adverse event reports in the FDA's MAUDE database, received between Aug 22, 2017 and May 28, 2026 — classified as 10 injuries, 233 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (76 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 Endo Hernia problems
Device problems
- Detachment of Device or Device Component76
- Failure to Fire67
- Failure to Form Staple55
- Break31
- Mechanics Altered17
- Adverse Event Without Identified Device or Use Problem10
- Display or Visual Feedback Problem9
- Loss of or Failure to Bond9
Patient problems
- No Clinical Signs, Symptoms or Conditions161
- No Consequences Or Impact To Patient35
- No Known Impact Or Consequence To Patient23
- Insufficient Information15
- No Code Available6
- Tissue Breakdown5
- Foreign Body In Patient4
- Obstruction/Occlusion3
Multifire Endo Hernia models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Multifire Endo Hernia 174027Laparoscope, general & plastic surgery101 reports
- Multifire Endo Hernia 174025Laparoscope, general & plastic surgery86 reports
- Multifire Endo Hernia 174007Laparoscope, general & plastic surgery33 reports
- Multifire Endo Hernia 174015Laparoscope, general & plastic surgery23 reports
Recent Multifire Endo Hernia adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 28, 2026Failure to Fire
ACCORDING TO THE REPORTER DURING A CLOSING OF THE PETERSON'S DEFECT IN BARIATRIC SURGERY, THE HERNIA STAPLER WAS UNABLE TO BE FIRED AND FELT JAMMED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25312046 ↗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 25298813 ↗MalfunctionApr 21, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A HERNIA REPAIR PROCEDURE, THE TIP OF THE DEVICE BROKE OFF IN THE PATIENT WHEN FIRED. THE BROKEN PIECE WAS RETRIEVED. IT WAS NOTED THAT THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MINUTES.
Patient problems: Foreign Body In Patient; Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24935185 ↗MalfunctionFeb 19, 2026Component or Accessory Incompatibility; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE STAPLER FIRED WITHOUT ISSUE WITH THE PRE-LOADED STAPLES, BUT WHEN THE SECOND RELOAD WAS INSERTED, THE STAPLER FAILED TO CORRECTLY SEAT THE STAPLES. THE STAPLES FELL OUT PRIOR TO FIRING. A NEW RELOAD WAS USED, BUT THE SAME ISSUE OCCURRED WITH ONE SIDE CLOSING CORRECTLY AND THE OTHER FAILING. THE RELOADS WERE TESTED ON ANOTHER STAPLER WHICH WAS OPENED AND THE RELOADS FUNCTIONED CORRECTLY. THE RELOADS WERE THEN CHECKED ON THE ORIGINAL STAPLER AND STILL FAILED TO OPERATE AS IT SHOULD. THE ISSUE RESULTED IN LESS THAN 5 MINUTES OF PROLONGED SURGICAL TIME. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24385853 ↗MalfunctionFeb 19, 2026Component or Accessory Incompatibility; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE STAPLER FIRED WITHOUT ISSUE WITH THE PRE-LOADED STAPLES, BUT WHEN THE SECOND RELOAD WAS INSERTED, THE STAPLER FAILED TO CORRECTLY SEAT THE STAPLES. THE STAPLES FELL OUT PRIOR TO FIRING. A NEW RELOAD WAS USED, BUT THE SAME ISSUE OCCURRED WITH ONE SIDE CLOSING CORRECTLY AND THE OTHER FAILING. THE RELOADS WERE TESTED ON ANOTHER STAPLER WHICH WAS OPENED AND THE RELOADS FUNCTIONED CORRECTLY. THE RELOADS WERE THEN CHECKED ON THE ORIGINAL STAPLER AND STILL FAILED TO OPERATE AS IT SHOULD. THE ISSUE RESULTED IN LESS THAN 5 MINUTES OF PROLONGED SURGICAL TIME. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24385852 ↗MalfunctionFeb 19, 2026Component or Accessory Incompatibility; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THE STAPLER FIRED WITHOUT ISSUE WITH THE PRE-LOADED STAPLES, BUT WHEN THE SECOND RELOAD WAS INSERTED, THE STAPLER FAILED TO CORRECTLY SEAT THE STAPLES. THE STAPLES FELL OUT PRIOR TO FIRING. A NEW RELOAD WAS USED, BUT THE SAME ISSUE OCCURRED WITH ONE SIDE CLOSING CORRECTLY AND THE OTHER FAILING. THE RELOADS WERE TESTED ON ANOTHER STAPLER WHICH WAS OPENED AND THE RELOADS FUNCTIONED CORRECTLY. THE RELOADS WERE THEN CHECKED ON THE ORIGINAL STAPLER AND STILL FAILED TO OPERATE AS IT SHOULD. THE ISSUE RESULTED IN PROLONGED SURGICAL TIME. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24385802 ↗MalfunctionJan 22, 2026Mechanics Altered
IT WAS REPORTED THAT DURING A PROCEDURE, THE STAPLES OF THE HERNIA STAPLER DID NOT DEPLOY. THE DEVICE WAS REPLACED WITH ANOTHER OF THE SAME PRODUCT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24153788 ↗MalfunctionJan 2, 2026Break; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A HERNIA REPAIR, PART OF THE DEVICE BECAME DETACHED AND ENTERED THE PATIENT. THE RELOAD COMPONENT OF THE INSTRUMENT BROKE, AND THE BROKEN PART DISENGAGED, CAUSING PIECES TO FALL INTO THE PATIENT CAVITY. ALL PIECES WERE RETRIEVED AND DISCARDED, AND THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23951693 ↗MalfunctionJul 24, 2025Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING THE LAPAROSCOPIC PROMONTO-FIXATION PROCEDURE, WHEN THE SURGEON NEEDED TO FIX THE MESH, THE TWO HERNIA STAPLERS WERE UNABLE TO FIRE. THE STAPLES WERE BLOCKED INSIDE THE RELOAD AND THE RELOAD DID NOT FUNCTION AS USUAL WHEN THE SURGEON PRESSED THE HANDLE TO FIRE THE STAPLERS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22598322 ↗MalfunctionJul 24, 2025Failure to Fire; Failure to Fire
IT WAS REPORTED THAT DURING THE LAPAROSCOPIC PROMONTO-FIXATION PROCEDURE, WHEN THE SURGEON NEEDED TO FIX THE MESH, THE TWO HERNIA ST APLERS WERE UNABLE TO FIRE. THE STAPLES WERE BLOCKED INSIDE THE RELOAD AND THE RELOAD DID NOT FUNCTION AS USUAL WHEN THE SURGEON PRESSED THE HANDLE TO FIRE THE STAPLERS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22597211 ↗MalfunctionJul 22, 2025Break; Failure to Fire; Break; Failure to Fire
IT WAS REPORTED THAT DURING LAPAROSCOPIC HERNIA REPAIR, DURING CLOSURE OF THE PERITONEUM, THE STAPLER WAS OPENED INTO THE STERILE FIELD AND INSERTED INTO THE ABDOMEN. WHEN THE TRIGGER WAS PULLED, THE FRONT CASING OF THE TRIGGER OPENED, PREVENTING THE STAPLE FROM BEING DEPLOYED. THE STAPLES COULD NOT BE IMPLANTED DUE TO THE BROKEN HANDLE. NO PART OF THE DEVICE FELL INTO THE ABDOMEN. ANOTHER DEVICE WAS OPENED TO COMPLETE THE PROCEDURE, RESULTING IN A DELAY OF NO MORE THAN FIVE MINUTES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22569354 ↗MalfunctionApr 2, 2025Break; Break
ACCORDING TO THE REPORTER, DURING A HERNIA REPAIR PROCEDURE, WHEN THE TRIGGER WAS PRESSED, THE BODY OF THE DEVICE OPENED UP. ANOTHER DEVICE HAD TO BE OPENED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21756815 ↗MalfunctionMar 20, 2025Failure to Fire; No Apparent Adverse Event; Failure to Fire; No Apparent Adverse Event
ACCORDING TO THE REPORTER, PRE-OPERATIVELY, TACKS WERE UNABLE TO BE FIRED NORMALLY FROM THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21655287 ↗InjuryMar 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT POSTOPERATIVELY OF A BILATERAL TRANSABDOMINAL PREPERITONEAL (TAPP) INGUINAL HERNIA LAPAROSCOPIC PROCEDURE, AN ADHESION OF THE CLIP TO THE BOWEL OCCURRED AFTER THE PROCEDURE. MEDICAL OR SURGICAL INTERVENTION WAS NEEDED TO REMOVE THE ADHESION TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THE ADHERENCE OF THE CLIP TO THE BOWEL WAS RESOLVED BY REMOVING THE ADHESION. THE PATIENT WAS RE-OPERATED IN ANOTHER HOSPITAL. THE SURGEON REMOVED THE STAPLES THAT HAD COME UNDONE.
Patient problems: Adhesion(s)
MAUDE report 21602779 ↗MalfunctionMar 13, 2025Failure to Fire; Failure to Fire
IT WAS REPORTED THAT NO STAPLES WERE ABLE TO BE FIRED NORMALLY FROM THE TWO DEVICE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21596998 ↗
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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