ReliaTack RELTACK3X10SWRecalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10884521726376), received between Jun 29, 2018 and Jun 28, 2024 — classified as 2 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Component or Accessory Incompatibility” (10 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 28, 2024Positioning Failure; Misfire; Positioning Failure; Misfire

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HERNIA REPAIR, THE TACKER MISFIRED. ANOTHER TACKER WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19639175 ↗
• MalfunctionApr 2, 2024Component or Accessory Incompatibility; Adverse Event Without Identified Device or Use Problem; Component or Accessory Incompatibility; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC INCISIONAL HERNIA REPAIR PROCEDURE, WHILE LOADING THE DEVICE FOR MIX FIXATION, THE DEVICE WAS UNABLE TO LOAD. THE ISSUE OCCURRED IN 5 DEVICES. THE SURGEON DID NOT USE THE DEVICES ON THE PATIENT. A NEW TACKER WAS OPENED AND USED TO RESOLVE THE ISSUE. THIS LED TO MORE THAN 30 MINUTES EXTENDED SURGICAL TIME.

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

  MAUDE report 19027289 ↗
• MalfunctionApr 2, 2024Component or Accessory Incompatibility; Adverse Event Without Identified Device or Use Problem; Component or Accessory Incompatibility; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC INCISIONAL HERNIA REPAIR PROCEDURE, WHILE LOADING THE DEVICE FOR MIX FIXATION, THE DEVICE WAS UNABLE TO LOAD. THE ISSUE OCCURRED IN 5 DEVICES. THE SURGEON DID NOT USE THE DEVICES ON THE PATIENT. A NEW TACKER WAS OPENED AND USED TO RESOLVE THE ISSUE. THIS LED TO MORE THAN 30 MINUTES EXTENDED SURGICAL TIME.

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

  MAUDE report 19023318 ↗
• MalfunctionApr 2, 2024Component or Accessory Incompatibility; Adverse Event Without Identified Device or Use Problem; Component or Accessory Incompatibility; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC INCISIONAL HERNIA REPAIR PROCEDURE, WHILE LOADING THE DEVICE FOR MIX FIXATION, THE DEVICE WAS UNABLE TO LOAD. THE ISSUE OCCURRED IN 5 DEVICES. THE SURGEON DID NOT USE THE DEVICES ON THE PATIENT. A NEW TACKER WAS OPENED AND USED TO RESOLVE THE ISSUE. THIS LED TO MORE THAN 30 MINUTES EXTENDED SURGICAL TIME.

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

  MAUDE report 19023174 ↗
• MalfunctionApr 2, 2024Component or Accessory Incompatibility; Adverse Event Without Identified Device or Use Problem; Component or Accessory Incompatibility; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC INCISIONAL HERNIA REPAIR PROCEDURE, WHILE LOADING THE DEVICE FOR MIX FIXATION, THE DEVICE WAS UNABLE TO LOAD. THE ISSUE OCCURRED IN FIVE DEVICES. THE SURGEON DID NOT USE THE DEVICES ON THE PATIENT. A NEW TACKER WAS OPENED AND USED TO RESOLVE THE ISSUE. THIS LED TO MORE THAN 30 MINUTES EXTENDED SURGICAL TIME.

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

  MAUDE report 19020311 ↗
• MalfunctionApr 2, 2024Component or Accessory Incompatibility; Adverse Event Without Identified Device or Use Problem; Component or Accessory Incompatibility; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC INCISIONAL HERNIA REPAIR PROCEDURE, WHILE LOADING THE DEVICE FOR MIX FIXATION, THE DEVICE WAS UNABLE TO LOAD. THE ISSUE OCCURRED IN FIVE DEVICES. THE SURGEON DID NOT USE THE DEVICES ON THE PATIENT. A NEW TACKER WAS OPENED AND USED TO RESOLVE THE ISSUE. THIS LED TO MORE THAN 30 MINUTES EXTENDED SURGICAL TIME.

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

  MAUDE report 19020289 ↗
• InjuryOct 3, 2023Break; Device Difficult to Setup or Prepare; Detachment of Device or Device Component; Break; Device Difficult to Setup or Prepare; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VENTRAL HERNIA, THERE WAS DIFFICULTY LOADING THE RELOAD INTO THE HANDLE BUT WAS ULTIMATELY ABLE TO BE LOADED. WHEN THE DEVICE WAS BEING FIRED TO TACK THE MESH, THE RELOAD CARTRIDGE POPPED OFF AND THE TACK FELL INTO THE PATIENT CAVITY. THE RELOAD CARTRIDGE WAS DAMAGED. AN X-RAY WAS PERFORMED TO LOCATE AND RETRIEVE THE TACK. ANOTHER DEVICE WAS OPENED TO RESOLVE THE ISSUE.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 17864947 ↗
• MalfunctionAug 22, 2023Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR, THE ISSUE OCCURRED DURING THE STEP OF TACKING THE MESH INTO THE RECTUS MUSCLE. SPECIFICALLY, THE DEVICE'S RELOADS WOULD NOT CONNECT TO THE TACKER PROPERLY, WITH TWO OUT OF THREE RELOADS FAILING TO CONNECT. TO RESOLVE THE PROBLEM, A NEW TACKER WAS USED, AND THE RELOADS WORKED CORRECTLY, ALLOWING THE PROCEDURE TO BE COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17598129 ↗
• MalfunctionMar 31, 2022Device Difficult to Setup or Prepare

  2 OUT OF 3 CLIPS DID NOT CLIP ON EASILY FOR LOADING; DEVICE REPLACED. DID NOT INJURE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13964710 ↗
• MalfunctionNov 18, 2021Positioning Failure; Device Difficult to Setup or Prepare; Positioning Failure; Device Difficult to Setup or Prepare

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A VENTRAL HERNIA REPAIR, THERE WERE DIFFICULTIES WITH LOADING THE RELOAD ONTO THE HANDLE AND THE DEVICE WAS NOT ABLE TO FIRE TACKS. THE DEVICE JAMMED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 12833939 ↗
• MalfunctionMar 17, 2021Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  ACCORDING TO THE REPORTER, THERE WAS DIFFICULTY LOADING THE RELOAD ONTO THE HANDLE DURING LAPAROSCOPIC VENTRAL HERNIA REPAIR. THE FIRST RELOAD WAS ABLE TO BE ATTACHED. THE SCRUB ATTEMPTED TO RELOAD THE TACKER, BUT BOTH THE OTHER RELOADS WOULD NOT ATTACH AFTER MULTIPLE TIMES. ANOTHER TACKER WAS USED, AND THE OTHER TWO RELOADS WERE ABLE TO BE LOADED AND USED TO THE PATIENT TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11510046 ↗
• MalfunctionFeb 11, 2021Component or Accessory Incompatibility; Component or Accessory Incompatibility

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC VENTRAL HERNIA REPAIR, THE USER HAD DIFFICULTY WITH LOADING THE RELOAD ONTO THE HANDLE. THE "PUSH TO RELOAD" BUTTON WAS DIFFICULT TO PRESS. THE DEVICE WAS NOT USED ON THE PATIENT. ANOTHER TACKER WAS USED TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THE DISTAL SLEEVE WAS DISENGAGED AND MISSING. BOTH LOCK BALLS WERE MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11315075 ↗
• MalfunctionOct 24, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE FIRST LOAD WORKED FINE DURING A LAPAROSCOPIC UMBILICAL HERNIA, THE TECH RELOADED THE DEVICE AND THE SURGEON PLACED THE DEVICE THROUGH THE TROCAR HOWEVER, THE RELOAD DISENGAGED FROM THE HANDLE AND FELL INTO THE PATIENT. THE SURGEON RETRIEVED THE RELOAD WITH A GRASPER AND OPENED A NEW DEVICE TO FINISH THE CASE. THE PATIENT IS FINE WITH NO INJURY AND THE CASE WENT FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10731924 ↗
• InjuryJul 9, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, SOME TIME POST-OPERATIVELY OF A LAPAROSCOPIC VENTRAL HERNIA REPAIR, DURING FOLLOW UP DUE TO DISCOMFORT, THE SURGEON DISCOVERED THAT A RELOAD WAS IN THE PATIENT¿S ABDOMEN. THE RELOAD WAS REMOVED FROM THE PATIENT IN A SEPARATE PROCEDURE.

  Patient problems: Discomfort

  MAUDE report 10252298 ↗
• MalfunctionMar 26, 2020Positioning Failure; Device Difficult to Setup or Prepare; Positioning Failure; Device Difficult to Setup or Prepare

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VENTRAL HERNIA, ON THE FINAL STEP OF SECURING THE MESH TO THE ABDOMINAL WALL, THERE WERE DIFFICULTIES WITH LOADING THE RELOAD ONTO THE HANDLE. AFTER THE LOADING ISSUES WERE EXPERIENCED, THE RELOAD WAS USED IN THE PATIENT. THE DEVICE JAMMED AND WOULD NOT FIRE. THEY OPENED A NEW ONE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9886520 ↗
• MalfunctionMar 25, 2020Positioning Failure; Device Difficult to Setup or Prepare; Component or Accessory Incompatibility; Mechanical Jam; Positioning Problem; Positioning Failure; Device Difficult to Setup or Prepare; Component or Accessory Incompatibility; Mechanical Jam; Positioning Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR, WHEN THEY SECURED THE MESH TO THE ABDOMINAL WALL, THERE WERE DIFFICULTIES WITH LOADING THE RELOAD ONTO THE HANDLE. THERE WAS DIFFICULTY IN ARTICULATING THE DEVICE. THE TACKS WERE ABLE TO FIRED NORMALLY. THE DEVICE JAMMED AND UNABLE TO BE RELOADED AND WOULD NOT FIRE THE TACKS. THE INCISION WAS EXTENDED BY LESS THAN 1 INCH. THEY OPENED ANOTHER UNIT TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9876661 ↗
• MalfunctionMar 18, 2020Component or Accessory Incompatibility; Component or Accessory Incompatibility

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR, AFTER FIRING THE DEVICE AND EMPTYING THE FIRST RELOAD. THE DEVICE WAS NOT ACCEPTING THE NEW RELOAD. THE SURGICAL TECHNICIAN TRIED TO TROUBLESHOOT THE DEVICE, THEREBY SURGICAL TIME WAS EXTENDED MORE THAN 30 MINUTES. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9849155 ↗
• MalfunctionJan 6, 2020Device Difficult to Setup or Prepare; Difficult to Remove; Component or Accessory Incompatibility; Device Difficult to Setup or Prepare; Difficult to Remove; Component or Accessory Incompatibility

  ACCORDING TO THE REPORTER, DURING LOADING OF HERNIA TACKER ON A LAPAROSCOPIC HERNIA REPAIR, THE DEVICE WAS DIFFICULT TO LOAD AND UNABLE TO REMOVE THE YELLOW PIECE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9552722 ↗
• MalfunctionOct 25, 2019Loss of or Failure to Bond; Component or Accessory Incompatibility; Loss of or Failure to Bond; Component or Accessory Incompatibility

  ACCORDING TO THE REPORTER, WHEN FIXATING THE MESH DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR, SEVERAL TACKS WORKED AS INTENDED, BUT ONE TACK EVENTUALLY WAS NOT ABLE TO RELEASE FROM THE DEVICE WHEN PLACED INTO THE MESH. THE SURGEON HAD TO PULL THE DEVICE OUT WHILE STILL ENGAGED, AND IT PULLED THE MESH OFF. ADDITIONAL RELOADS COULD NOT BE LOCKED ONTO THE HANDLE, AND COULD NOT BE SECURELY FASTENED ONTO THE SHAFT. THE SURGEON SWITCHED TO ANOTHER DEVICE TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9241301 ↗
• MalfunctionMay 31, 2019Mechanical Jam

  DURING CASE, THE TACKER LOCKED UP. NO HARM TO PATIENT. ANOTHER TACKER OPENED TO COMPLETE THE CASE. DESCRIPTION OF PROCEDURE: WE THEN ATTACHED THE MESH TO THE ABDOMINAL WALL USING APPROXIMATELY 40 ABSORBATACKS PLACING THEM EVERY 1 TO 2 CM AROUND THE PERIMETER OF THE MESH FOLLOWED BY A DOUBLE CROWN OF TACKS. A COMPLETION LAPAROSCOPIC SURVEY WAS PERFORMED. THERE WERE NO COMPLICATIONS. NO BLEEDING OR OTHER ABNORMALITIES WERE NOTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8658016 ↗
• MalfunctionMay 23, 2019Positioning Failure; Device Difficult to Setup or Prepare; Positioning Failure; Device Difficult to Setup or Prepare

  ACCORDING TO THE REPORTER DURING A LAPAROSCPIC INGUINAL HERNIA REPAIR WITH MESH IMPLANTATION, WHEN SECURING THE MESH TO THE ABDOMINAL WALL, AFTER DIFFICULTY LOADING A RELOAD, THE SURGEON CYCLED THE DEVICE SO THE PADDLE WAS VERTICAL. THE SURGEON THEN ATTEMPTED TO TACK THE MESH INSIDE THE PATIENT AND THE DEVICE CONTINUED TO MISFIRE. NONE OF THE TACKS WERE ABLE TO BE FIRED NORMALLY FROM THE DEVICE. ANOTHER TACKER WAS OPENED TO FINISH THE CASE. THERE WAS NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8636710 ↗
• MalfunctionDec 5, 2018Mechanical Problem; Misfire

  DURING LAPAROSCOPIC DA VINCI PROCEDURE, THE RELIATACK ARTICULATING RELOADABLE FIXATION DEVICE MALFUNCTIONED. PROCEDURAL NOTE: ... RIGHT FLANK HERNIA WAS FOUND FROM PREVIOUS LUMBAR FUSION. THIS HERNIA DEFECT WAS ABOUT 5 CM IN LENGTH BUT IN THIS POSITION WAS ABOUT 1.5-2 CM WIDE. I USED A 10 X 15 SYMBOTEX MESH WHICH WAS INSERTED INTO THE ABDOMEN. THE CARTER-THOMASON WAS USED TO GRAB THE STITCHES AND BRING THE TRANSFIXING STITCHES INTO POSITION SO THAT THIS MESH WAS CENTERED AND COVERED THE DEFECT. AFTER THIS WAS DONE, IT WAS TACKED DOWN WITH ABSORBABLE TACKS. HOWEVER, FOR THE SECOND TIME RECENTLY I HAD PROBLEMS WITH THIS MISFIRING AND BEING UNABLE TO REATTACH A SECOND LOAD OF TACKS. THEREFORE, I SWITCHED TO THE PROTACKER IN ORDER TO FINISH ANCHORING THIS MESH IN POSITION. CARE WAS TAKEN NOT TO INJURE BOWEL OR ANY ABDOMINAL STRUCTURES. MY TRANSFIXING STITCHES WERE CINCHED DOWN.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8132737 ↗
• MalfunctionJun 29, 2018Detachment Of Device Component; Mechanics Altered; Detachment Of Device Component; Mechanics Altered

  ACCORDING TO THE REPORTER, WHILE TACKING THE MESH DURING A LAPAROSCOPIC VENTRAL HERNIA REPAIR, THERE WERE DIFFICULTIES WITH LOADING THE RELOAD ONTO THE HANDLE AND THE TACKS FELL OFF THE MESH ONTO THE VISCERA OF THE PATIENT. THEY OPENED UP A NEW TACKER TO COMPLETE THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7651425 ↗