ProTack 174006Recalls & reported problems

Summary

The FDA's MAUDE database contains 709 adverse event reports that list this exact device (DI 10884521070400), received between Apr 5, 2017 and Sep 23, 2026 — classified as 64 injuries, 645 malfunctions.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (245 reports).

2 other recalls cover devices cleared under the same FDA submission (K090470); they may or may not involve this specific model.

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 25 most recent of 709 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Separation Problem

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 50874869 ↗
• MalfunctionSep 15, 2026Detachment of Device or Device Component

  It was reported that during a laparoscopic sacrocolpopexy procedure, the tacks fell into the situs and were retrieved laparoscopically using grasping forceps. The procedure was prolonged by greater than 30 minutes to remove the tacks and complete the mesh fixation using suture material.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50774018 ↗
• MalfunctionAug 18, 2026Break

  Patient problems: Insufficient Information

  MAUDE report 50309030 ↗
• MalfunctionAug 12, 2026Detachment of Device or Device Component

  It was reported that preoperatively, the tack holder inside the product came out. A new device was used to resolve the issue. There was no patient involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50227636 ↗
• MalfunctionAug 6, 2026Mechanical Jam

  Patient problems: Insufficient Information

  MAUDE report 50154579 ↗
• MalfunctionJun 10, 2026Failure to Advance

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY (LASH) WITH URINARY BLADDER LIFT, THREE TACKERS WERE USED INSIDE THE BODY DURING MESH APPLICATION, THE TACKS COULD NOT BE SECURED AND WERE NOT PROPERLY EJECTED BY THE HANDLES. THE MESH WAS SUTURED IN PLACE, AND THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES.

  Patient problems: Tissue Breakdown

  MAUDE report 25460140 ↗
• MalfunctionJun 10, 2026Failure to Advance

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY (LASH) WITH URINARY BLADDER LIFT, THREE TACKERS WERE USED INSIDE THE BODY DURING MESH APPLICATION, THE TACKS COULD NOT BE SECURED AND WERE NOT PROPERLY EJECTED BY THE HANDLES. THE MESH WAS SUTURED IN PLACE, AND THE SURGICAL TIME WAS EXTENDED BY MORE THAN 30 MINUTES.

  Patient problems: Tissue Breakdown

  MAUDE report 25459955 ↗
• MalfunctionApr 21, 2026Failure to Advance

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HERNIA REPAIR, THE DEVICE WAS USED FOR THE MESH FIXATION STEP WHEN THE FIRST TWO DEPLOYMENTS WERE SMOOTH AND PROPER, BUT THE NEXT THREE DEPLOYMENTS WERE MISSED. THE TACKS DID NOT COME OUT PROPERLY FROM THE DEVICE AND BECAME PARTIALLY STUCK IN THE MESH WHILE PARTIALLY REMAINING INSIDE THE DEVICE, WHICH MADE IT DIFFICULT TO REMOVE. A NEW PACK 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 24940847 ↗
• MalfunctionMar 24, 2026Misfire; Noise, Audible

  IT WAS REPORTED THAT DURING A PROCEDURE, THE DEVICE MISFIRED AND WAS NOT CONSISTENT. THE DEVICE MAKES A CRUNCH JUST TRYING TO FIRE THE FIRST TIME.

  Patient problems: Insufficient Information

  MAUDE report 24676303 ↗
• MalfunctionMar 23, 2026Positioning Failure; Display or Visual Feedback Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC UMBILICAL HERNIA PROCEDURE, TWO TACKS WERE FIRED AT SAME TIME AND TACKS WERE NOT ABLE TO RELEASE FROM THE DEVICE. SUTURING WAS DONE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24661515 ↗
• MalfunctionFeb 16, 2026Separation Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC, THE USER TRIED TO FIRE IT EIGHT TIMES, NO STAPLES CAME OUT. THE OTHER ONE, THE STAPLES SEEM TO HAVE SIMPLY FALLEN OUT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24355206 ↗
• MalfunctionFeb 13, 2026Misfire

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE TACKER MISFIRED.

  Patient problems: Insufficient Information

  MAUDE report 24339229 ↗
• MalfunctionJan 23, 2026Mechanical Jam

  ACCORDING TO THE REPORTER, DURING USE, THE TACKER FIRED ONLY ONCE THEN JAMMED.

  Patient problems: Insufficient Information

  MAUDE report 24169888 ↗
• MalfunctionJan 20, 2026Failure to Advance

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC BILATERAL INGUINAL HERNIOPLASTY, THE TACKER GOT STUCK WHILE FIXING THE MESH ON COOPER'S LIGAMENT IN INGUINAL ANATOMY. THE ISSUE WAS RESOLVED BY USING A NEW TACKER 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 24123407 ↗
• MalfunctionJan 5, 2026Break

  ACCORDING TO THE REPORTER, DURING A TRANSABDOMINAL PREPERITONEAL HERNIA, DURING FIXATION OF THE SURGICAL MESH, THE FIRST TACKER FIRED, BUT THE SPRING FELL OUT FROM THE SHAFT. A SECOND TACKER WAS USED, AND AFTER FIRING THREE TIMES, THE TACK BECAME STUCK. A NEW FIXATOR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23967163 ↗
• MalfunctionDec 23, 2025Failure to Advance; Failure to Advance

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC TENSION-FREE REPAIR OF THE LINEA ALBA HERNIA, DURING STAPLING OF THE HERNIA MESH WITH THE TACKER, POOR SEPARATION OCCURRED BETWEEN THE HELICAL TACK AND THE FIXATOR, RESULTING IN DAMAGE TO PART OF THE PERITONEAL TISSUE AND DISPLACEMENT OF THE MESH. TO RESOLVE THE ISSUE, MEDICAL ADHESIVE WAS ADDITIONALLY USED FOR FIXATION.

  Patient problems: Tissue Breakdown

  MAUDE report 23881562 ↗
• MalfunctionDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, WHILE SECURING THE MESH WITH THE TWO TACKERS, BLEEDING OCCURRED. THE BLEEDING WAS MANAGED WITHOUT ANY PROBLEMS, AND CLOSURE WAS COMPLETED USING A SUTURE FROM ANOTHER BRAND.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23823813 ↗
• MalfunctionDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, WHILE SECURING THE MESH WITH THE TWO TACKERS, BLEEDING OCCURRED. THE BLEEDING WAS MANAGED WITHOUT ANY PROBLEMS, AND CLOSURE WAS COMPLETED USING A SUTURE FROM ANOTHER BRAND.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23823787 ↗
• MalfunctionDec 9, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT A LAPAROSCOPIC INGUINAL HERNIA PROCEDURE, THE DEVICE JAMMED AND DID NOT PENETRATE THE TISSUE AS INTENDED. A NEW DEVICE OF THE SAME TYPE 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 23763836 ↗
• MalfunctionDec 8, 2025Positioning Failure; Entrapment of Device; Positioning Failure; Entrapment of Device

  IT WAS REPORTED THAT DURING A BILATERAL LAPAROSCOPIC HERNIA REPAIR PROCEDURE, ON ONE SIDE, SIX TACKERS WERE FIRED WITHOUT ANY PROBLEMS. HOWEVER, ON THE OTHER SIDE, DURING MESH FIXATION, THE DEVICE DID NOT RELEASE THE TACKER BUT INSTEAD PULLED THE MESH AND THE UNDERLYING TISSUE ALONG, ESSENTIALLY ¿CATCHING¿ THEM. AS A RESULT, A VASCULAR INJURY OCCURRED, CAUSING MINOR ARTERIAL BLEEDING. AFTER SUCTION AND IRRIGATION, THE SOURCE OF THE BLEEDING WAS COAGULATED; THERE WAS NO SIGNIFICANT BLOOD LOSS, ONLY THE SURGICAL TIME WAS INCREASED BY APPROXIMATELY 35 MINUTES. A SUCTION DRAIN WAS LEFT IN THE SURGICAL AREA.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Tissue Breakdown

  MAUDE report 23751287 ↗
• MalfunctionDec 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, ALL THE TITANIUM TACKS INSIDE THE FIXATOR FELL OUT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23720240 ↗
• MalfunctionDec 4, 2025Product Quality Problem; Failure to Advance; Product Quality Problem; Failure to Advance

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC INGUINAL HERNIA PROCEDURE, WHILE BEING USED FOR FIXATING THE MESH, TACKS COMING OUT IN STRANGE SHAPE AND DID NOT PENETRATE. TACKS WERE RETRIEVED AND THE PROCEDURE CONTINUED WITHOUT ISSUES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23720206 ↗
• MalfunctionNov 28, 2025Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC INCISIONAL HERNIA REPAIR, THE TACKER WAS UNABLE TO FIRE STAPLES OUT SMOOTHLY AND EXPERIENCED JAMMING PROBLEMS WHILE BEING USED TO FIXATE THE MESH. THE ISSUE WAS RESOLVED BY REPLACING THE DEVICE WITH A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23669721 ↗
• MalfunctionOct 27, 2025Failure to Advance; Failure to Advance

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, WHILE THE SURGEON WAS FIRING THE TACKER, A TACK WAS STUCK IN THE DEVICE AND CAME OUT HALFWAY WHICH CAUSE THE PATIENT¿S TISSUE TO TEAR WHEN THE SURGEON TRIED TO REMOVE THE TACK.

  Patient problems: Tissue Breakdown

  MAUDE report 23394397 ↗
• InjurySep 9, 2025Separation Problem; Separation Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC RE-DO RECTOPEXY PROCEDURE, THE DEVICE WAS FIRED, BUT THE TACKS FAILED, AND A TACK COMPONENT FELL INTO THE CAVITY OF THE PATIENT. IT WAS NOTED THAT NO X-RAY WAS PERFORMED TO LOCATE OR CONFIRM RETRIEVAL OF THE TACK. TWO DEVICES WERE TRIED WITHOUT SUCCESS, AND THE THIRD DEVICE FUNCTIONED AS INTENDED, ALLOWING THE PROCEDURE TO BE COMPLETED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body In Patient

  MAUDE report 23001830 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K090470. One submission often covers many models, so check the product and lot details in each record.

• Z-0986-2024 · Nov 16, 2023 · Open, Classified
  AbsorbaTack Absorbable Fixation Device 30 Violet Absorbable Tacks 5 mm- -intended for fixation of prosthetic material to soft tissue in minimally invasive and open surgical hernia
• Z-1157-2010 · Feb 8, 2010 · Terminated
  Auto Suture ProTack Fixation 5 mm Product Catalogue # 174006. Has application in endoscopic surgery procedures.