Stat Tack OMS-TTSSRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884521070509), received between Dec 12, 2017 and Jul 15, 2024 — classified as 5 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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. 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2024Misfire; Misfire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE MISFIRED.

  Patient problems: Insufficient Information

  MAUDE report 19740168 ↗
• MalfunctionAug 21, 2023Display or Visual Feedback Problem; Display or Visual Feedback Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC INGUINAL HERNIA REPAIR, FIXATION OF MESH, ALL TACKS DEPLOYED AT ONCE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17591799 ↗
• MalfunctionApr 21, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN HERNIA REPAIR, THE DEVICE BROKE INTERNALLY. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11700268 ↗
• InjurySep 29, 2020Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED FROM 2008 TO 2018, POSTOPERATIVE FROM MIDLINE LAPAROTOMY WITH BOWEL RESECTION, 5 PATIENTS HAD INFECTION, 1 PATIENT HAD MESH REMOVAL, 8 PATIENTS HAD SEROMA IN WHICH 4 WERE SUBSEQUENTLY DRAINED, 8 PATIENTS HAD PERSISTING PAIN AND 3 PATIENTS HAD HEMATOMA IN WHICH 2 REQUIRED SURGERY. FOR THE PATIENTS WHO UNDERWENT ILEOSTOMY REVERSAL, 3 PATIENTS HAD INFECTION, 1 PATIENT HAD SEROMA WHICH WAS SUBSEQUENTLY DRAINED, 4 PATIENTS HAD PERSISTING PAIN AND 1 PATIENT HAD HEMATOMA WHICH REQUIRED SURGERY. THESE COMPLICATIONS WERE NOT RELATED TO THE DEVICE REPORTED.

  Patient problems: Hematoma; No Code Available; No Consequences Or Impact To Patient; Pain; Seroma; Unspecified Infection

  MAUDE report 10599199 ↗
• MalfunctionJun 1, 2020Display or Visual Feedback Problem; Detachment of Device or Device Component; Display or Visual Feedback Problem; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC INGUINAL HERNIA REPAIR, THE DEVICE JAMMED AT THE FIRST CLICK AS THE TACKER IS BEING APPLIED ONTO THE MESH. THE SURGEON CLICKED THE DEVICE A FEW MORE TIMES AND THREE TACKS CAME OUT AND FELL INTO THE PATIENT'S CAVITY ONE AFTER THE OTHER. THE TACKS WERE RETRIEVED LAPAROSCOPICALLY AND A NEW DEVICE IS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10105541 ↗
• InjuryApr 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, POST-OPERATIVE OF A PROCEDURE FOR PROLAPSE, THE PATIENT DEVELOPED PELVIC PAIN. THE MESH WAS MOBILIZED UP TO THE SACRUM AND WAS REMOVED AT HYSTERECTOMY AS ALSO NEEDED DUE TO PERSISTENT ENDOMETRIAL THICKNESS. DURING LAPAROSCOPY, SIGNIFICANT INTRA-ABDOMINAL ADHESIONS WERE OBSERVED HENCE WE CONVERTED THE PROCEDURE TO MID-LINE LAPAROTOMY. EXTENSIVE ADHESIOLYSIS WAS PERFORMED. PATIENT'S HAEMOGLOBIN DID DROP TO 94 WHICH IS INCONSISTENT WITH TOTAL BLOOD LOSS INTRA OPERATIVELY. THEREFORE, THE PATIENT WAS ARRANGED FOR AN ULTRASOUND SCAN OF HER PELVIS WHICH WAS NORMAL WITH NO LARGE COLLECTION NOTED. HER HAEMOGLOBIN WAS >110 PRIOR TO BEING DISCHARGE. HER SKIN SUTURES WILL BE REMOVED IN 10-14 DAYS.

  Patient problems: Adhesion(s); Hyperplasia; No Code Available; Pain

  MAUDE report 9935586 ↗
• MalfunctionOct 16, 2019Mechanical Jam; Mechanical Jam

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC INGUINAL HERNIA REPAIR, THE DEVICE JAMMED HALF WAY THROUGH THE TACKING PROCESS. A NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9198497 ↗
• MalfunctionDec 27, 2018Detachment of Device or Device Component; Mechanical Jam; Detachment of Device or Device Component; Mechanical Jam

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA, THE DEVICE JAMMED IN THE MIDDLE OF THE PROCEDURE. THE DEVICE COMPONENT FELL INTO THE CAVITY OF THE PATIENT AND WAS NOT RETRIEVED. THEY OPENED A NEW DEVICE TO COMPLETE THE CASE.

  Patient problems: Foreign Body In Patient

  MAUDE report 8199152 ↗
• InjuryJan 19, 2018Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Noise, Audible; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Noise, Audible

  ACCORDING TO THE REPORTER: OCCURRED DURING AN UMBILICAL HERNIA REPAIR WITH MESH PROCEDURE. THE PATIENT HAD MILD PERIUMBILICAL PAIN. BOTH TACKING DEVICES CRUNCHED AND THEN DID NOT WORK. THE EVENT OUTCOME WAS HOSPITALIZATION. NO INJURIES OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7205502 ↗
• InjuryJan 19, 2018Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Noise, Audible; Mechanics Altered; Adverse Event Without Identified Device or Use Problem; Noise, Audible

  ACCORDING TO THE REPORTER: OCCURRED DURING AN UMBILICAL HERNIA REPAIR WITH MESH PROCEDURE. THE PATIENT HAD MILD PERIUMBILICAL PAIN. BOTH TACKING DEVICES CRUNCHED AND THEN DID NOT WORK. THE EVENT OUTCOME WAS HOSPITALIZATION. NO INJURIES OR COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7205481 ↗
• InjuryJan 7, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE RESULTING IN AN UNSPECIFIED ADVERSE OUTCOME. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. THE PATIENT UNDERWENT A REPAIR OF VENTRAL INCISIONAL HERNIA. SHE HAS PHYSICIAN RECOMMENDATION AGAINST SURGICAL REVISION DUE TO EXTENSIVE NERVE DAMAGE CAUSED BY MESH IMPLANT. THE PATIENT EXPERIENCED RIGHT SIDE OF MESH PATCH WRINKLED AND INCORPORATED INTO ABDOMINAL WALL TISSUE AND PERIOPERATIVE NERVE DAMAGE.

  Patient problems: Injury; Nerve Damage; No Code Available

  MAUDE report 7170683 ↗
• MalfunctionDec 12, 2017Positioning Failure; Device Contamination with Chemical or Other Material; Positioning Failure; Device Contamination with Chemical or Other Material

  ACCORDING TO THE REPORTER, A HAIR STRAND WAS FOUND INSIDE THE STAT TACK STERILE PACK BEFORE DEVICE WAS HANDED TO SURGEON FOR USE. DEVICE WITH HAIR WAS PUT TO THE SIDE AND NEW ONE WAS OPENED WITH NO ISSUE. ADDITIONALLY, THE TACKS WERE ABLE TO BE FIRED BUT HAD NOT BEEN USED IN THE PATIENT AS THE PRODUCT WAS CONTAMINATED. THERE WAS NO PATIENT INVOLVEMENT IN THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 7109036 ↗

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.