AbsorbaTack ABSTACK30Recalls & reported problems
Covidien LP · Fixation Device;30 Violet Absorbable Tacks · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
Quick summary
This Covidien AbsorbaTack is a set of absorbable tacks used to fix mesh in place during hernia repair. Many of its 451 reports describe tacks that did not hold or fell into the body cavity, tackers that were hard to fire or broke, and the surgeon switching to another tacker. The reports list 31 injuries, no deaths and 420 malfunctions. There is 1 recall, open since November 2023, over packaging seals that may be too weak to keep the tacks sterile.
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
- 455
- Deaths reported
- 0
- Injuries reported
- 31
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 455 adverse event reports that list this exact device (DI 10884523006520), received between Jun 19, 2017 and Sep 30, 2026 — classified as 31 injuries, 424 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (130 reports).
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Nov 16, 2023Open, Classified
Packaging of the device may cause a low seal strength in the side seal of the foil pouch potentially resulting in a sterile/moisture barrier breach, compromising the product sterility
Z-0986-2024 · Root cause: Process control · FDA record ↗
Most reported problems
Device problems
- Loss of or Failure to Bond130
- Positioning Failure104
- Break90
- Detachment of Device or Device Component69
- Adverse Event Without Identified Device or Use Problem58
- Failure to Advance47
- Separation Problem34
- Material Twisted/Bent30
Patient problems
- No Clinical Signs, Symptoms or Conditions268
- No Known Impact Or Consequence To Patient62
- No Consequences Or Impact To Patient61
- Insufficient Information30
- Unspecified Tissue Injury14
- Foreign Body In Patient10
- No Code Available10
- No Information9
Recent adverse event reports
The 25 most recent of 455 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Mechanical Jam
It was reported during a procedure that the tack jammed when multiple attempts were made to fire it. Eventually, the tack fired successfully. There was no patient injury reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947637 ↗MalfunctionSep 21, 2026Positioning Failure; Detachment of Device or Device Component; Firing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846778 ↗MalfunctionSep 21, 2026Positioning Failure; Detachment of Device or Device Component; Firing Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846765 ↗MalfunctionSep 21, 2026Failure to Advance
It was reported that during laparoscopic IPOM (Intraperitoneal Onlay Mesh) incisional hernia repair, four tacks fired successfully but upon deployment of the fifth tack, the tack became stuck in the mesh, and the mesh tore when force was applied. The fired tacks did not penetrate tissue; however, some fired tacks held correctly onto tissue. A new tacker was used to complete the procedure. No patient complications have been reported as a result of this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50836962 ↗MalfunctionAug 26, 2026Separation Problem
It was reported that during laparoscopic bilateral inguinal hernia repair with mesh fixation, the device failed to secure any of the fixation points during the bilateral inguinal herniorrhaphy. 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 50446296 ↗MalfunctionAug 14, 2026Failure to Advance; Separation Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50251296 ↗MalfunctionAug 12, 2026Mechanical Jam
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50222367 ↗MalfunctionAug 12, 2026Firing Problem; Separation Problem
According to the reporter, in a laparoscopic hernia procedure, during mesh fixation, the tacker had a tight trigger which made the device difficult to cock. When forced, the tacks were able to penetrate the tissue but were unable to hold onto the tissue correctly and kept falling into the cavity. The tacks were retrieved. To resolve the issue, the surgeon exerted more effort in pressing the trigger to release the tacks. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50217332 ↗MalfunctionAug 11, 2026Positioning Failure; Display or Visual Feedback Problem
According to the reporter, during a laparoscopic incisional hernia repair, after mesh placement, when the surgeon fired the two tackers, no tacks were deployed. Upon subsequent activation, 3 to 4 tacks were released automatically. The same issue occurred repeatedly during use. There was no patient injury.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50210734 ↗MalfunctionAug 11, 2026Positioning Failure; Display or Visual Feedback Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50210728 ↗MalfunctionJul 28, 2026
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50056724 ↗MalfunctionJun 30, 2026Break
IT WAS REPORTED THAT A TACKER APPEARED TO BE DAMAGED DURING SURGERY AND WAS REPLACED WITH ANOTHER TACKER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25663230 ↗MalfunctionJun 26, 2026Failure to Advance
ACCORDING TO THE REPORTER, THE MATERIAL DID NOT FUNCTION DUE TO DIFFICULTY IN COUPLING.
Patient problems: Insufficient Information
MAUDE report 25639239 ↗MalfunctionJun 19, 2026Positioning Failure; Adverse Event Without Identified Device or Use Problem; Firing Problem
ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC INTRAPERITONEAL ONLAY MESH (IPOM) FOR AN UMBILICAL HERNIA, WHILE FIXING THE MESH TO THE VENTRAL WALL, 17 TO 18 TACKS WERE FIRED WITH DIFFICULTY. THE TACKER WAS HARD TO USE. AFTER FIRING 17 TO 18 TACKS, THE DEVICE COMPLETELY STOPPED DEPLOYING THE REST OF THE TACKS. ANOTHER TACKER WAS USED TO COMPLETE THE CASE. THE PROCEDURE WAS EXTENDED FOR 30 MINUTES OR MORE AS A RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25562201 ↗MalfunctionJun 18, 2026Failure to Advance; Separation Problem
IT WAS REPORTED THAT DURING A LAPAROSCOPIC HERNIA REPAIR PROCEDURE (TEP), WHILE FIXING THE MESH, THE DEVICE BECAME STUCK AND WAS NOT ACTIVE. TACKS WERE ABLE TO BE FIRED; HOWEVER, THE FIRED TACKS DID NOT PENETRATE THE TISSUE OR HOLD PROPERLY. THE DEVICE WAS REPLACED WITH A NEW ONE TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25553751 ↗MalfunctionJun 18, 2026Positioning Failure; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A LAPAROSCOPIC HERNIOPLASTY ON THE ABDOMINAL WALL USING THE TACKER, NO TACKS WERE ABLE TO BE FIRED NORMALLY AND ALL TACKS CAME OUT OF THE INSTRUMENT. IT WAS NOTED THAT THE TACKS DISENGAGED AND FELL INTO THE PATIENT CAVITY AND WERE RETRIEVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25553414 ↗MalfunctionJun 9, 2026Separation Problem
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC BILATERAL INGUINAL HERNIORRHAPHY, WHILE ON MESH FIXATION, THE TACKS DID NOT PROVIDE ADEQUATE FIXATION. IT REMAIN UNSTABLE AND DETACH ON THEIR OWN. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25449579 ↗MalfunctionMay 29, 2026Failure to Advance
IT WAS REPORTED THAT DURING A HERNIA REPAIR, THE INSTRUMENT WAS NOT FIRING THE TACKS AS IT SHOULD DURING THE MESH FIXATION STEP. THE MESH WAS NOT SECURED BY THE TACKS. A SECOND TACKER WAS OPENED AND USED TO SECURE THE MESH 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 25332193 ↗MalfunctionMay 22, 2026Failure to Advance; Firing Problem
IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE WHILE HANDLING AND REALIGNING MESH, FIXATION DEVICE HAD A WEAK INJECTOR AND FAILED TO FIRE PROPERLY ON A SINGLE ATTEMPT. IT WAS ALSO REPORTED THAT THE TRIGGER WAS STIFF AND MALFUNCTIONING, REQUIRING EXCESSIVE FORCE AND MULTIPLE ATTEMPTS TO ACTIVATE. THE DEVICE WAS REPLACED WITH A NEW ONE 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 25257935 ↗MalfunctionMay 21, 2026Failure to Advance
IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE DID NOT SECURE THE MESH IN PLACE. THE TACKS DID NOT STAY IN THE FABRIC.
Patient problems: Insufficient Information
MAUDE report 25237997 ↗MalfunctionApr 21, 2026Misfire
ACCORDING TO THE REPORTER DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, THE SINGLE USE 30 TACKS DEVICE MISFIRED. A NEW 5MM 15 TACKS FIXATOR WAS USED TO RESOLVE THE ISSUE BUT ALSO MISFIRED. THE SURGERY WAS DELAYED A BIT WHILE TRYING TO FIND A DEVICE, THEN A NEW TACKLER WAS OPENED AND USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24935710 ↗MalfunctionApr 15, 2026Positioning Failure; Failure to Advance
IT WAS REPORTED THAT DURING A LAPAROSCOPIC VENTRAL HERNIA PROCEDURE, THE TWO TACKERS WERE UNABLE TO FIRE. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 24888656 ↗MalfunctionApr 15, 2026Positioning Failure; Failure to Advance
IT WAS REPORTED THAT DURING A LAPAROSCOPIC VENTRAL HERNIA PROCEDURE, THE TWO TACKERS WERE UNABLE TO FIRE. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 24888543 ↗MalfunctionApr 15, 2026Positioning Failure; Misfire; Separation Problem
IT WAS REPORTED THAT DURING A LAPAROSCOPIC INTRAPERITONEAL ONLAY MESH (IPOM), WHILE FIRING THE TACKER TO FIXATE MESH, THE DEVICE WAS NOT WORKING AFTER FEW FIRES AND THE TACKS WHICH WAS FIRED WERE UNABLE TO HOLD THE TISSUE. THE CASE WAS COMPLETED USING ANOTHER BRAND'S TACKER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24887580 ↗MalfunctionApr 11, 2026Misfire
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, THE FIRST TACKER MISFIRED. THE SAME ISSUE OCCURRED WITH THE SECOND DEVICE. A NEW DEVICE FROM A DIFFERENT MANUFACTURER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 24851155 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.