AbsorbaTack ABSTACK30XRecalls & reported problems
Covidien LP · Fixation Device;30 Violet Absorbable Tacks · Class 2
Quick summary
This Covidien AbsorbaTack is an absorbable tack used to fix surgical mesh during hernia repair. Its 105 reports, 10 of them injuries, mostly describe the tacking device failing to fire, breaking, or not releasing tacks into the tissue, and in many cases a new tacking device was used to finish the operation. There were no deaths, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 105
- Deaths reported
- 0
- Injuries reported
- 10
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 105 adverse event reports that list this exact device (DI 10884521184213), received between Aug 10, 2017 and Apr 21, 2026 — classified as 10 injuries, 95 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (40 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Loss of or Failure to Bond40
- Break23
- Detachment of Device or Device Component17
- Positioning Failure13
- Failure to Advance10
- Material Twisted/Bent10
- Mechanics Altered8
- Adverse Event Without Identified Device or Use Problem6
Patient problems
- No Clinical Signs, Symptoms or Conditions53
- No Known Impact Or Consequence To Patient25
- No Consequences Or Impact To Patient18
- Insufficient Information5
- No Code Available3
- Abdominal Pain2
- Fatigue2
- Foreign Body In Patient2
Recent adverse event reports
The 25 most recent of 105 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 21, 2026Break
IT WAS REPORTED THAT DURING A LAPAROSCOPIC BILATERAL INGUINAL HERNIOPLASTY, WHEN FIXING A LARGE MESH IN THE INGUINAL REGION, THE TAC KER BROKE UPON FIRING. A NEW TACKER WAS REQUESTED AND WORKED PROPERLY TO COMPLETE THE PROCEDURE. THE PERITONEUM WAS THEN CLOSED WITH A BARBED SUTURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24935316 ↗MalfunctionApr 7, 2026Failure to Advance
IT WAS REPORTED THAT DURING THE LAPAROSCOPIC HERNIA REPAIR, WHEN ON THE FIXATION OF MESH, THE TACK DID NOT FIXATE THE MESH, WHICH REQUIRED THE USE OF ANOTHER DEVICE 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 24811381 ↗MalfunctionMar 24, 2026Break; Positioning Failure
ACCORDING TO THE REPORTER, AT THE BEGINNING OF LAPAROSCOPIC INGUINAL HERNIORRHAPHY. THE TACKER DID NOT FIRE AND THE DEVICE WAS DAMAGED, INPUT CABLE BROKE, EXPOSING THE BRAIDS. ANOTHER TACKER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24672128 ↗MalfunctionMar 19, 2026Failure to Advance
IT WAS REPORTED THAT DURING A LAPAROSCOPIC HERNIA REPAIR, THE DEVICE FAILED TO PENETRATE TISSUE DURING MESH FIXATION. A NEW TACKER OF THE SAME TYPE WAS USED 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 24641587 ↗InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT FOLLOWING A SURGICAL PROCEDURE IN (B)(6) 2019 FOR AN UMBILICAL HERNIA AND DIASTASIS, A HIGH EVENTRATION OCCURRED, INDICATING RECURRENCE OR NEW HERNIATION AFTER THE INITIAL SURGERY, AND IT WAS ALLEGED THAT THE FIRST PROSTHESES FAILED. A SECOND OPERATION WAS PERFORMED IN (B)(6) 2020 WITH IMPLANTATION OF MESH. SINCE THESE PROCEDURES, THE INDIVIDUAL EXPERIENCED CHRONIC AND VERY FREQUENT STOMACH PAIN, DIGESTION PROBLEMS, ACCUMULATED FATIGUE, INABILITY TO RESUME SPORTS AND NORMAL LIFE, HEART PROBLEMS WITH TACHYCARDIA, SUSPICION OF MYOCARDITIS AND/OR PERICARDITIS, SYMPTOMS SIMILAR TO A HEART ATTACK, LUNG PROBLEMS, HOSPITALIZATION, AND ONGOING MONITORING OF THE LUNGS. NUMEROUS MEDICAL TESTS WERE CONDUCTED, WHICH REVEALED NO SPECIFIC FINDINGS, AND A DIAGNOSIS OF "LONG COVID" WAS MADE. THE INDIVIDUAL ALSO REPORTED PSYCHOLOGICAL IMPACT AND CONSEQUENCES ON MORALE.
Patient problems: Abdominal Pain; Fatigue; Hernia; Tachycardia; Unspecified Gastrointestinal Problem; Unspecified Heart Problem; Unspecified Respiratory Problem
MAUDE report 24637857 ↗InjuryMar 19, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT FOLLOWING A SURGICAL PROCEDURE IN (B)(6) 2019 FOR AN UMBILICAL HERNIA AND DIASTASIS, A HIGH EVENTRATION OCCURRED, INDICATING RECURRENCE OR NEW HERNIATION AFTER THE INITIAL SURGERY, AND IT WAS ALLEGED THAT THE FIRST PROSTHESES FAILED. A SECOND OPERATION WAS PERFORMED IN (B)(6) 2020 WITH IMPLANTATION OF MESH. SINCE THESE PROCEDURES, THE INDIVIDUAL EXPERIENCED CHRONIC AND VERY FREQUENT STOMACH PAIN, DIGESTION PROBLEMS, ACCUMULATED FATIGUE, INABILITY TO RESUME SPORTS AND NORMAL LIFE, HEART PROBLEMS WITH TACHYCARDIA, SUSPICION OF MYOCARDITIS AND/OR PERICARDITIS, SYMPTOMS SIMILAR TO A HEART ATTACK, LUNG PROBLEMS, HOSPITALIZATION, AND ONGOING MONITORING OF THE LUNGS. NUMEROUS MEDICAL TESTS WERE CONDUCTED, WHICH REVEALED NO SPECIFIC FINDINGS, AND A DIAGNOSIS OF "LONG COVID" WAS MADE. THE INDIVIDUAL ALSO REPORTED PSYCHOLOGICAL IMPACT AND CONSEQUENCES ON MORALE.
Patient problems: Abdominal Pain; Fatigue; Hernia; Tachycardia; Unspecified Gastrointestinal Problem; Unspecified Heart Problem; Unspecified Respiratory Problem
MAUDE report 24637752 ↗MalfunctionMar 11, 2026Break; Difficult to Remove; Detachment of Device or Device Component; Material Twisted/Bent
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A LAPAROSCOPIC UMBILICAL HERNIA REPAIR, DURING MESH FIXATION, A TACKER WITH 30 TACKS WAS USED INITIALLY. AFTER THE TACKER WAS INSERTED INTO THE TROCAR, THE SHAFT OF THE TROCAR GOT BENT AND BROKEN. THE SURGEON COULD NOT REMOVE THE TACKER FROM THE TROCAR. THE SURGEON COULD NOT FIRE ANY TACKS PROPERLY. TACKS FELL INTO THE CAVITY OF THE PATIENT AND WERE RETRIEVED. A TACKER WITH 15 TACKS WAS USED AFTERWARDS. HOWEVER, AFTER FOUR TACKS, THE TRIGGER OF THE TACKER GOT HARD AND DID NOT FUNCTION PROPERLY. TACKS ALSO FELL INTO THE CAVITY OF THE PATIENT AND WERE RETRIEVED. SUTURING WAS DONE INSTEAD TO FIX THE MESH. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24566924 ↗MalfunctionJan 28, 2026Failure to Advance
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INTRAPERITONEAL ONLAY MESH (IPOM) PROCEDURE, DURING MESH FIXATION, THE DEVICE MALFUNCTIONED, WHEREIN MULTIPLE TACKERS WERE NOT COMPLETELY RELEASED FOLLOWING APPLICATION. DESPITE APPROPRIATE POSITIONING AND STANDARD DEPLOYMENT TECHNIQUE, THE TACKS REMAINED PARTIALLY ATTACHED TO THE DELIVERY MECHANISM INSTEAD OF BEING FULLY RELEASED INTO THE TISSUE. THE SURGEON USED A NEW TACKER TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24205834 ↗MalfunctionJan 8, 2026Firing Problem; Separation Problem
IT WAS REPORTED THAT DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR, SOME TACKS WERE HARD TO FIRE AND SOME TACKS DID NOT HOLD WELL WHILE FIRING THE TACKER. A NEW TACKER WAS OPENED TO RESOLVE THE ISSUE AND 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 24005072 ↗MalfunctionDec 5, 2025Break; Break
IT WAS REPORTED THAT DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR, WHILE FIXING MESH WITH THE DEVICE, THE SHAFT WAS BROKEN. A NEW DEVICE WAS USED FROM OTHER COMPANY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23725970 ↗MalfunctionNov 6, 2025Break; Positioning Failure; Break; Positioning Failure
ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC INGUINAL HERNIA REPAIR, DURING MESH FIXATION, TACKING WAS DONE ONCE BUT DURING THE SECOND FIRING, THE TACK DID NOT COME OUT AND WHEN THE DEVICE WAS CHECKED, FRACTURE IN THE PRODUCT WAS NOTED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23487116 ↗MalfunctionOct 24, 2025Failure to Advance; Failure to Advance
IT WAS REPORTED THAT DURING A LAPAROSCOPIC HERNIA REPAIR, THE DEVICE WAS USED TO FIX THE MESH ONTO THE PERITONEUM. THE TACKER GOT STUCK WHILE FIRING, AND THE TACKS DID NOT HOLD THE MESH AND THE TISSUE PROPERLY. ANOTHER TACKER WAS USED 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 23380221 ↗MalfunctionOct 3, 2025Positioning Failure; Separation Problem; Positioning Failure; Separation Problem
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, ALL FOUR TACKS FIRED DID NOT ADHERE TO THE TISSUE, THEN THE FIFTH TACK FIRED JAMMED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23208183 ↗MalfunctionSep 2, 2025Positioning Failure; Separation Problem; Positioning Failure; Separation Problem
ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC HERNIA REPAIR, AFTER MESH PLACEMENT, THE TACK WAS NOT FIRED PROPERLY AND WOULD NOT HOLD THE MESH WELL. THE SURGEON USED A SUTURE TO FIX THE MESH TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 22929762 ↗MalfunctionJul 8, 2025Misfire; Physical Resistance/Sticking; Misfire; Physical Resistance/Sticking
ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE MISFIRE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22439235 ↗MalfunctionMay 28, 2025Break; Break
ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC HERNIA, PRIOR TO PATIENT USE, WHEN THE PACKAGING OF THE TACKER WAS OPENED. IT WAS FOUND THAT THE SHAFT WAS ALREADY BROKEN. A NEW TACKER WAS USED TO RESOLVE THE ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22093518 ↗MalfunctionMay 21, 2025Positioning Failure; Mechanical Jam; Positioning Failure; Mechanical Jam
IT WAS REPORTED THAT DURING A LAPAROSCOPIC HERNIA REPAIR PROCEDURE, WHILE TACKING THE MESH, THE TACKS WERE STUCK IN THE SHAFT AND DID NOT FIRE. THE TACKER WAS REPLACED TO RESOLVE THE ISSUE AND 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 22067008 ↗MalfunctionMar 31, 2025Failure to Advance; Failure to Advance
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ABDOMINAL WALL SCAR HERNIA REPAIR, WHEN FIXING THE MESH TO THE ABDOMINAL WALL, THE TACKS WERE ABLE TO TACK NORMALLY, BUT WHEN TACKING THE OPPOSITE SIDE, THE TACK THAT WAS SUPPOSED TO BE STOPPED/FIXED WAS REMOVED. AS A RESULT, ALL THE TACKS AT THE PLACES BEING STRUCK WERE REMOVED. A NEW TACKER FROM ANOTHER COMPANY WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21731597 ↗MalfunctionMar 14, 2025Break; Break
ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC MESH FIXATION PROCEDURE, PRIOR TO PATIENT USE, THE SHAFT OF THE DEVICE WAS ALMOST BROKEN. A NEW TACKER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21605158 ↗InjuryFeb 18, 2025Separation Problem; Separation Problem
ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC BILATERAL INGUINAL HERNIA REPAIR THE TACKER WAS BEING APPLIED TO MUSCLE AND COOPERS LIGAMENT TO SECURE THE MESH. WHILE USING THE DEVICE THE TACKER MISFIRED AND IT WAS NOTED THAT THE TACKS FELL INTO THE PATIENT'S CAVITY AND WAS RETRIEVED USING LAPAROSCOPIC GRASPER. ANOTHER TACKER WAS OPENED OF THE SAME LOT AND WAS FOUND TO HAVE THE SAME ISSUE. TO COMPLETE THE PROCEDURE ANOTHER TACKER WAS OPENED AND USED WITHOUT AN ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions; Prolapse
MAUDE report 21400638 ↗InjuryFeb 11, 2025Separation Problem; Separation Problem
ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC BILATERAL INGUINAL HERNIA REPAIR THE TACKER WAS BEING APPLIED TO MUSCLE AND COOPERS LIGAMENT TO SECURE THE MESH. WHILE USING THE DEVICE THE TACKER MISFIRED AND IT WAS NOTED THAT THE TACKS FELL INTO THE PATIENT'S CAVITY AND WAS RETRIEVED USING LAPAROSCOPIC GRASPER. ANOTHER TACKER WAS OPENED OF THE SAME LOT AND WAS FOUND TO HAVE THE SAME ISSUE. TO COMPLETE THE PROCEDURE ANOTHER TACKER WAS OPENED AND USED WITHOUT AN ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions; Prolapse
MAUDE report 21358771 ↗MalfunctionJan 9, 2025Failure to Advance; Detachment of Device or Device Component; Failure to Advance; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INCISIONAL HERNIA REPAIR, THE TACKS DID NOT FIXATE THE MESH ON THE ABDOMINAL WALL AND FELL INTO THE PATIENT'S CAVITY. THE TACK WAS RETRIEVED AND REMOVED THROUGH THE MAIN PORT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21113487 ↗MalfunctionDec 13, 2024Positioning Failure; Failure to Advance; Material Twisted/Bent; Firing Problem; Positioning Failure; Failure to Advance; Material Twisted/Bent; Firing Problem
ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC INTRAPERITONEAL ONLAY MESH (IPOM), WHILE FIXING THE MESH, THE TACKER GOT STUCK AND THE SHAFT OF THE DEVICE WAS BENT. THE SURGEON FELT A LOT OF DIFFICULTY WHILE FIRING. THE TACKS WOULD NOT FIRE PROPERLY TO THE MESH. TACKS WOULD ALSO NOT COME OUT WHILE FIRING. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20924801 ↗MalfunctionAug 26, 2024Failure to Advance; Failure to Advance
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR PROCEDURE, WHEN FIXATING THE MESH IN THE INGUINAL SPACE, THE FIRST THREE TACKS WERE FIRED AS EXPECTED. IN THE NEXT FIRINGS, THE TACKS WERE FIRED BUT THEY WERE NOT ADHERING TO THE MESH. THE TACKS DID NOT FIXATE THE MESH TO TISSUE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20062441 ↗MalfunctionJul 10, 2024Material Twisted/Bent; Separation Problem; Material Twisted/Bent; Separation Problem
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC BILATERAL HERNIA REPAIR PROCEDURE, WHEN FIXING THE MESH TO THE ABDOMINAL WALL FOR CORRECTION, THE TACKS DID NOT STAY FIRM IN THE FABRIC WHICH CAUSED THE SHAFT TO BENT. ANOTHER TACKER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19711401 ↗
Other STAPLE, IMPLANTABLE devices
- Endo GIA EGIA60AMTCovidien LP · STAPLE, IMPLANTABLE19 deaths10,680 reports
- Endo GIA Ultra EGIAUSTNDCovidien LP · STAPLE, IMPLANTABLE5 deaths9,730 reports
- Signia SIGPHANDLECovidien LP · STAPLE, IMPLANTABLE1 recall3 deaths5,356 reports
- ECHELON FLEX PSEE60AEthicon Endo-Surgery, LLC · STAPLE, IMPLANTABLE1 recall13 deaths3,294 reports
- Endo GIA Ultra EGIAUSHORTCovidien LP · STAPLE, IMPLANTABLE2 deaths3,011 reports
- Endo GIA EGIA45AMTCovidien LP · STAPLE, IMPLANTABLE10 deaths2,965 reports
- Endo GIA Ultra EGIAUXLCovidien LP · STAPLE, IMPLANTABLE2,909 reports
- ENDOPATH ATS45Ethicon Endo-Surgery, LLC · STAPLE, IMPLANTABLE2 deaths2,046 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.