AbsorbaTack ABSTACK20SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884523006155), received between Dec 13, 2018 and May 5, 2023 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (3 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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2023Loss of or Failure to Bond; Positioning Failure; Loss of or Failure to Bond; Positioning Failure

  ACCORDING TO THE REPORTER, DURING AN OPEN INCISIONAL HERNIA REPAIR, IN INTRAPERITONEAL ONLAY MESH REPAIR (IPOM) PLACEMENT, AFTER FIRING APPROXIMATELY SIX TACKS, THE SURGEON FELT THAT THE TACKER WAS NOT FIRING ANYTHING. AFTER ANOTHER FIRE, THE USER REALIZED THAT THE TACKS WERE NOT PENETRATING INTO THE TISSUE. THE MESH COULD BE REMOVED FROM THE ABDOMINAL CAVITY EASILY AS THE TACKS WERE NOT FIXATED INTO THE TISSUE TO HOLD THE MESH ADEQUATELY IN PLACE. AN EXTERNAL COUNTERPRESSURE ON THE ABDOMEN WAS APPLIED WITH EACH FIRING OF THE TACKER. THE SURGEON REMOVED A FEW TACKS FROM THE MESH TO CHECK IF THE MESH COULD BE REUSED; HOWEVER, THE DEVICE COULD NOT BE RE-IMPLANTED. TO RESOLVE THE ISSUE, A COMPETITOR MESH WAS USED WITH A NEW TACKER WITH THE SAME LOT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16877812 ↗
• MalfunctionDec 1, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER DURING OPEN INCISIONAL VENTRAL HERNIA REPAIR , THE DEVICE DID FIRE TO FIXATE THE MESH BUT THE TACKERS DID NOT STAY IN THE TISSUE AND FELL OUT. THE SURGEON HAD TO REMOVE THE TACKERS LAYING ON THE MESH AND ENDED UP FIXATING THE MESH WITH COMPETITOR PERMANENT SUTURES TO RESOLVE THE ISSUE. THE SURGICAL TIME WAS EXTENDED FOR AN HOUR. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12909971 ↗
• MalfunctionAug 5, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  ACCORDING TO THE REPORTER, DURING AN OPEN HERNIA REPAIR, ON SECURING THE MESH SOME TACKS PENETRATED THE MESH AND OTHERS DIDN¿T. THE ONES THAT FAILED TO PENETRATE WERE REMOVED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10371189 ↗
• MalfunctionFeb 4, 2020Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE MISFIRED AFTER 2 FIRINGS.

  Patient problems: No Information

  MAUDE report 9666415 ↗
• InjuryDec 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, APPROXIMATELY 8 DAYS POST-OPERATIVELY OF AN OPEN VENTRAL HERNIA REPAIR, THE PATIENT RETURNED TO THE HOSPITAL WITH SEVERE PAIN AND WAS TAKEN BACK TO THE OPERATING ROOM FOR AN EXPLORATORY LAPAROTOMY. UPON OPENING THE SPACE, PUS AND INFECTION PRESENTED. MESH APPEARED TO BE INTACT AND DID NOT FAIL, BUT INFECTION WAS PRESENT. THE MESH AND TACKS HAD TO BE REMOVED. THE WOUND WAS DEBRIDED AND WOUND VAC (VACUUM-ASSISTED CLOSURE) WAS PLACED AND THE PATIENT WAS ADMITTED.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8160337 ↗