Gastrointestinal Anchor Set, SAF-T-PEXY* T-Fasteners 98701Recalls & reported problems

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 00350770987019), received between Oct 29, 2019 and Feb 19, 2026 — classified as 1 death, 9 injuries, 51 malfunctions.

The most frequently reported specific device problem is “Break” (43 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 61 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2026Fracture

  IT WAS REPORTED VIA FDA (B)(4), THERE WERE ALSO ISSUES WITH THE T-FASTENERS, POSSIBLY A DEVICE FAILURE. FASTENERS FRACTURED DURING INITIAL USE DURING PLACEMENT OF G-TUBE "[GASTRIC TUBE]".

  Patient problems: Insufficient Information

  MAUDE report 24388239 ↗
• MalfunctionOct 12, 2025Break; Break

  IT WAS REPORTED THE "SUTURE BREAKS AT ANCHOR WHEN LOCKED." THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23273728 ↗
• MalfunctionAug 12, 2025Break; Break

  ADDITIONAL INFORMATION RECEIVED 19-AUG-2025 REGARDING THE REPORTED INCIDENT NOTED, "THE SUTURE WAS BROKEN DURING THE PREPARATION STAGE, BEFORE BEING USED ON THE PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22784624 ↗
• MalfunctionApr 11, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "BALLOON LEAK, CAME OUT OF STOMA, LEAK FROM STOMA SITE AFTER 2 DAYS OF USE... RETURN TO SURGERY¿ FOR MIC-KEY REPLACEMENT AND THAT PATIENT WAS CURRENTLY INPATIENT AFTER ¿SECOND SURGERY.... MUM REPORTS TUBE WAS LEAKING - REDUCED FEEDS TO ½, THEN NOTED TUBE HAD FALLEN OUT...PATIENT WAS AN INPATIENT AFTER THE SECOND SURGERY ¿ THE PATIENT WAS ORIGINALLY DISCHARGED FOLLOWING THE FIRST INITIAL SURGERY OF THE GASTROSTOMY INSERTION, HE WAS THEN DISCHARGED AND THEN THE MIC-KEY BUTTON FELL OUT WHILE AT HOME AND, THEREFORE, PRESENTED BACK TO HOSPITAL AND REQUIRED A SECOND SURGERY WITHIN 1 WEEK FOR THE SECOND PLACEMENT OF THE GASTROSTOMY AND REQUIRED ADMISSION ON [THE] SURGICAL WARD FOR POST-OP MANAGEMENT AND CARE FOR A FURTHER 6-DAYS. ADDITIONAL INFORMATION RECEIVED 19-MAR-2025 STATED "IT WAS AN INITIAL TUBE INSERTION WHICH FELL OUT AND REQUIRED SURGERY FOR A SECOND PLACEMENT WITHIN A WEEK." THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21829789 ↗
• MalfunctionApr 9, 2025Break; Break

  IT WAS REPORTED TWO "SUTURES SNAPPED DURING OPERATION. NEW GASTROPEXY PACKAGE WAS OPENED AND REPLACED." THERE WAS NO REPORTED PATIENT INJURY. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21807255 ↗
• MalfunctionFeb 19, 2025Break; Break

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2025-00033 FOR THE SECOND EVENT. IT WAS REPORTED THE "SUTURES RUPTURED." THE DEVICE REMAINS IMPLANTED. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21412876 ↗
• DeathFeb 19, 2025Break; Break

  IT WAS REPORTED THE "SUTURES RUPTURED." THE PATIENT DIED FROM PERITONITIS.

  Patient problems: Peritonitis

  MAUDE report 21412875 ↗
• MalfunctionFeb 18, 2025Break; Break

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2025-00030 FOR THE FIRST EVENT. IT WAS REPORTED THE "SUTURES RUPTURED." THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 21401862 ↗
• MalfunctionNov 27, 2024Break; Break

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 9611594-2024-00272 FOR THE FIRST EVENT. REFER TO 9611594-2024-00273 FOR THE SECOND EVENT. IT WAS REPORTED THE SUTURES ARE TOO THIN AND BREAKS WHEN THE SURGEON PRESSED DOWN THE DILATOR TO FORM THE STOMA. THE GASTRO SURGEON STATED AT LEAST 1-2 SUTURES BROKE, WHICH RESULTED IN THE SURGEON HAVING TO USE THE STANDARD PROCEDURE INSTEAD. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20799392 ↗
• MalfunctionNov 27, 2024Break; Break

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 9611594-2024-00273 FOR THE SECOND EVENT. REFER TO 9611594-2024-00274 FOR THE THIRD EVENT. IT WAS REPORTED THE SUTURES ARE TOO THIN AND BREAKS WHEN THE SURGEON PRESSED DOWN THE DILATOR TO FORM THE STOMA. THE GASTRO SURGEON STATED AT LEAST 1-2 SUTURES BROKE, WHICH RESULTED IN THE SURGEON HAVING TO USE THE STANDARD PROCEDURE INSTEAD. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20799389 ↗
• MalfunctionNov 27, 2024Break; Break

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 9611594-2024-00272 FOR THE FIRST EVENT. REFER TO 9611594-2024-00274 FOR THE THIRD EVENT. IT WAS REPORTED THE SUTURES ARE TOO THIN AND BREAKS WHEN THE SURGEON PRESSED DOWN THE DILATOR TO FORM THE STOMA. THE GASTRO SURGEON STATED AT LEAST 1-2 SUTURES BROKE, WHICH RESULTED IN THE SURGEON HAVING TO USE THE STANDARD PROCEDURE INSTEAD. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20799341 ↗
• MalfunctionNov 21, 2024Break; Break

  IT WAS REPORTED TWO OF THE "SAF-T-PEXY T-FASTENERS BROKE DURING A PLACEMENT PROCEDURE." THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 30-OCT-2024 STATED, "THE SUTURES DID NOT LOOP CORRECTLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20750424 ↗
• MalfunctionNov 20, 2024Break; Break

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME (ONE) PATIENT. THIS IS THE THIRD OF FOUR REPORTS. REFER TO 9611594-2024-00260 FOR THE FIRST REPORT REFER TO 9611594-2024-00261 FOR THE SECOND REPORT REFER TO 9611594-2024-00263 FOR THE FOURTH REPORT. IT WAS REPORTED, FOUR T-FASTENERS WERE PLACED. ALL DETACHED AFTER A FEW DAYS. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 20737550 ↗
• MalfunctionNov 20, 2024Break; Break

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME (ONE) PATIENT. THIS IS THE FOURTH OF FOUR REPORTS. REFER TO 9611594-2024-00260 FOR THE FIRST REPORT. REFER TO 9611594-2024-00261 FOR THE SECOND REPORT. REFER TO 9611594-2024-00262 FOR THE THIRD REPORT. IT WAS REPORTED, FOUR T-FASTENERS WERE PLACED. ALL DETACHED AFTER A FEW DAYS. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 20737468 ↗
• MalfunctionNov 20, 2024Break; Break

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME (ONE) PATIENT. THIS IS THE SECOND OF FOUR REPORTS. REFER TO 9611594-2024-00260 FOR THE FIRST REPORT. REFER TO 9611594-2024-00262 FOR THE THIRD REPORT. REFER TO 9611594-2024-00263 FOR THE FOURTH REPORT. IT WAS REPORTED, FOUR T-FASTENERS WERE PLACED. ALL DETACHED AFTER A FEW DAYS. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 20737439 ↗
• MalfunctionNov 20, 2024Break; Break

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME (ONE) PATIENT. THIS IS THE FIRST OF FOUR REPORTS. REFER TO 9611594-2024-00261 FOR THE SECOND REPORT. REFER TO 9611594-2024-00262 FOR THE THIRD REPORT. REFER TO 9611594-2024-00263 FOR THE FOURTH REPORT. IT WAS REPORTED, FOUR T-FASTENERS WERE PLACED. ALL DETACHED AFTER A FEW DAYS. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 20737058 ↗
• MalfunctionNov 12, 2024Break; Break

  IT WAS REPORTED DURING USE "THE SUTURE STRINGS BROKE ON THE ANCHORS." THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20665589 ↗
• MalfunctionOct 17, 2024Crack; Crack

  IT WAS REPORTED THREE GASTROPEXY ANCHORS HAD CRACKS NOTED DURING PROCEDURE. ADDITIONAL INFORMATION RECEIVED 26-SEP-2024 NOTED "THE KIT THAT MALFUNCTIONED WAS USED AND WE PLACED ONE OF THE ANCHOR SET."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20474826 ↗
• InjurySep 24, 2024Unintended Movement; Premature Separation; Unintended Movement; Premature Separation

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE THIRD OF THREE REPORTS. REFER TO 9611594-2024-00199 FOR THE FIRST REPORT. REFER TO 9611594-2024-00200 FOR THE SECOND REPORT. IT WAS REPORTED, THE METAL BAR OF THE T-FASTENERS FELL OFF WITHIN 24 HOURS. PER ADDITIONAL INFORMATION RECEIVED ON 08SEP2024, PATIENT REQUIRED TWO ADDITIONAL VISITS TO THE INTERVENTIONAL RADIOLOGY (IR) SUITE: CONTRAST STUDY VIA RIG ON WAS PERFORMED ON (B)(6) 2024. GASTROPEXY WAS REATTEMPTED ON (B)(6) 2024. PATIENT REQUIRED ADDITIONAL HOSPITAL STAY AND A COURSE OF INTRAVENOUS ANTIBIOTICS. IT WAS ADDITIONALLY REPORTED, ¿26AUG2024 PROCEEDED TO HAVE A RADIOLOGICALLY INSERTED GASTROSTOMY (RIG) PROCEDURE. POST OP PAIN IN LEFT SHOULDER SECONDARY TO PNEUMOPERITONEUM, RESOLVED OVER NEXT FEW DAYS. POST-OP DAY 1 NOTED RIG LOOSE DISCS AND COMING AWAY FROM RIG - TAKEN BACK TO DSA FOR REVIEW AND FIXING, KEPT ON NASOGASTRIC TUBE (NGT) FEEDS ONLY. POST-OP DAY 2 ABDOMINAL PAIN, TAKEN BACK TO DSA FOR PARACENTESIS OF PNEUMOPERITONEUM AND REATTEMPT AT GASTROPEXY - FAILED TO PERFORM GASTROPEXY WITH ANCHORS, OPT

  Patient problems: Device Embedded In Tissue or Plaque; Fever; High White Blood Cell Count; Pain; Pneumoperitoneum; Skin Inflammation/ Irritation; Tachycardia

  MAUDE report 20294590 ↗
• InjurySep 24, 2024Unintended Movement; Premature Separation; Unintended Movement; Premature Separation

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF THREE REPORTS. REFER TO 9611594-2024-00199 FOR THE FIRST REPORT. REFER TO 9611594-2024-00201 FOR THE THIRD REPORT. IT WAS REPORTED, THE METAL BAR OF THE T-FASTENERS FELL OFF WITHIN 24 HOURS. PER ADDITIONAL INFORMATION RECEIVED ON 08SEP2024, PATIENT REQUIRED TWO ADDITIONAL VISITS TO THE (B)(6): CONTRAST STUDY VIA RIG ON WAS PERFORMED ON (B)(6) 2024. GASTROPEXY WAS REATTEMPTED ON (B)(6) 2024. PATIENT REQUIRED ADDITIONAL HOSPITAL STAY AND A COURSE OF INTRAVENOUS ANTIBIOTICS. IT WAS ADDITIONALLY REPORTED, ¿(B)(6) 2024 PROCEEDED TO HAVE A RADIOLOGICALLY INSERTED GASTROSTOMY (RIG) PROCEDURE. POST OP PAIN IN LEFT SHOULDER SECONDARY TO PNEUMOPERITONEUM, RESOLVED OVER NEXT FEW DAYS. POST-OP DAY 1 NOTED RIG LOOSE DISCS AND COMING AWAY FROM RIG - TAKEN BACK TO DSA FOR REVIEW AND FIXING, KEPT ON NASOGASTRIC TUBE (NGT) FEEDS ONLY. POST-OP DAY 2 ABDOMINAL PAIN, TAKEN BACK TO DSA FOR PARACENTESIS OF PNEUMOPERITONEUM AND REATTEMPT AT GASTROPEXY - FAILED TO PERFORM GASTROPEXY WITH ANCHORS, OPTED TO RELY ON TENSION FROM

  Patient problems: Device Embedded In Tissue or Plaque; Fever; High White Blood Cell Count; Pain; Pneumoperitoneum; Skin Inflammation/ Irritation; Tachycardia

  MAUDE report 20290098 ↗
• InjurySep 24, 2024Unintended Movement; Premature Separation; Unintended Movement; Premature Separation

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF THREE REPORTS. REFER TO 9611594-2024-00200 FOR THE SECOND REPORT. REFER TO 9611594-2024-00201 FOR THE THIRD REPORT. IT WAS REPORTED, THE METAL BAR OF THE T-FASTENERS FELL OFF WITHIN 24 HOURS. PER ADDITIONAL INFORMATION RECEIVED ON 08SEP2024, PATIENT REQUIRED TWO ADDITIONAL VISITS TO THE INTERVENTIONAL RADIOLOGY (IR) SUITE: CONTRAST STUDY VIA RIG ON WAS PERFORMED ON (B)(6) 2024. GASTROPEXY WAS REATTEMPTED ON (B)(6) 2024. PATIENT REQUIRED ADDITIONAL HOSPITAL STAY AND A COURSE OF INTRAVENOUS ANTIBIOTICS. IT WAS ADDITIONALLY REPORTED, ¿(B)(6) 2024 PROCEEDED TO HAVE A RADIOLOGICALLY INSERTED GASTROSTOMY (RIG) PROCEDURE. POST OP PAIN IN LEFT SHOULDER SECONDARY TO PNEUMOPERITONEUM, RESOLVED OVER NEXT FEW DAYS. POST-OP DAY 1 NOTED RIG LOOSE DISCS AND COMING AWAY FROM RIG - TAKEN BACK TO DSA FOR REVIEW AND FIXING, KEPT ON NASOGASTRIC TUBE (NGT) FEEDS ONLY. POST-OP DAY 2 ABDOMINAL PAIN, TAKEN BACK TO DSA FOR PARACENTESIS OF PNEUMOPERITONEUM AND REATTEMPT AT GASTROPEXY - FAILED TO PERFORM GASTROPEXY WITH ANCHORS, O

  Patient problems: Device Embedded In Tissue or Plaque; Fever; High White Blood Cell Count; Pain; Pneumoperitoneum; Skin Inflammation/ Irritation; Tachycardia

  MAUDE report 20290070 ↗
• MalfunctionSep 5, 2024Break; Break

  IT WAS REPORTED "THE CONCERNS EXPRESSED BY THE SURGEONS ARE THE T-FASTENERS BREAK VERY EASILY AND THEN THE TUBE IS DISLODGED INTO THE ABDOMINAL CAVITY AND NO LONGER ADHERED TO THE STOMACH. THIS HAS CAUSED INTRAPERITONEAL FLUID TO LEAK INTO THE ABDOMINAL CAVITY." NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20149695 ↗
• MalfunctionJun 7, 2024Break; Break

  IT WAS REPORTED, "THE ANCHOR BREAKS WHILE IN/ON PATIENT. ANCHOR COMES OUT OF PATIENT." NO INJURY REPORTED. PER ADDITIONAL INFORMATION RECEIVED ON 1-MAY-2024, "ANCHOR BREAKS DURING PROCEDURE. IN THIS CASE ANCHOR CAME OUT."

  Patient problems: Insufficient Information

  MAUDE report 19490384 ↗
• MalfunctionJun 6, 2024Break; Break

  IT WAS REPORTED, "THE ANCHOR BREAKS WHILE IN/ON PATIENT. ANCHOR COMES OUT OF PATIENT". NO INJURY REPORTED. PER ADDITIONAL INFORMATION RECEIVED ON 1-MAY-2024, "ANCHOR BREAKS DURING PROCEDURE. IN THIS CASE ANCHOR CAME OUT".

  Patient problems: Insufficient Information

  MAUDE report 19479701 ↗
• MalfunctionMay 23, 2024Break; Break

  IT WAS REPORTED, ¿THE ANCHOR BREAKS WHILE IN/ON PATIENT. ANCHOR COMES OUT OF PATIENT.¿ NO INJURY REPORTED. PER ADDITIONAL INFORMATION RECEIVED ON 1-MAY-2024, ¿ANCHOR BREAKS DURING PROCEDURE. IN THIS CASE ANCHOR CAME OUT.¿

  Patient problems: Insufficient Information

  MAUDE report 19383084 ↗