Halyard 98434Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10680651984347), received between Mar 2, 2017 and Mar 23, 2023 — classified as 2 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 23, 2023Failure to Eject; Failure to Eject

  IT WAS REPORTED THE "BARS MIGRATED. NO INJURY NOR MEDICAL INTERVENTION. THE T-BARS WERE PLACED IN (B)(6) 2022. (ABOUT 6 MONTHS AGO) IT WAS FOUND IN THE PROCESS OF MRT (MAGNETIC RESONANCE TEST) OR CT (COMPUTED TOMOGRAPHY). NO INJURY NOR MEDICAL INTERVENTION." ADDITIONAL INFORMATION RECEIVED 01-MAR-2023 STATED IT IS UNKNOWN AS TO WHY THE CT/ MRT WAS PERFORMED BUT IT WAS NOT DUE TO THE PATIENT'S WORSENED CONDITION. THE LOCATION OF THE T-BARS ON THE CT/MRT WAS NOTED TO BE SOMEWHERE BETWEEN GASTRIC WALL AND ABDOMINAL WALL. IT APPEARED THE T-BAR REMAINED IN THE LOCATION FOR A WHILE OR SINCE THE FIRST PLACEMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16598468 ↗
• MalfunctionFeb 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED "3 T-BARS MIGRATED. IT WAS FOUND BY X-RAY BECAUSE ANCHORS DID NOT DETACH." THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED (B)(6) 2023 "THIS EVENT WAS OBSERVED ABOUT 1 MONTH AFTER THE FIRST PLACEMENT. ALTHOUGH ALL THE 3-BARS MIGRATED, THE PATIENT CONDITION IS STILL FINE. NO SERIOUS INJURY OBSERVED."

  Patient problems: Foreign Body In Patient

  MAUDE report 16329027 ↗
• MalfunctionJan 29, 2020Break; Break

  IT WAS REPORTED THAT AN ANCHOR FAILED AFTER PLACEMENT. ITS RETAINING THREAD BROKE. PER ADDITIONAL INFORMATION RECEIVED 22 JAN 2020, THERE WAS NO CONSEQUENCES TO THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH OUT THE NEED TO OPEN A SECOND KIT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9641393 ↗
• MalfunctionJan 15, 2020Break; Break

  IT WAS REPORTED THAT AT THE END OF A GASTROPEXY PROCEDURE USING PUSH TECHNIQUE, THREE OF THE ANCHORS USED FROM THE KIT HAD BROKEN AND WERE NO LONGER IN PLACE. NO INJURY TO THE PATIENT. PER ADDITIONAL INFORMATION RECEIVED 07 JAN 2020, THE PATIENT REMAINS IN THE HOSPITAL, BUT FOR REASONS UNRELATED TO THE REPORTED INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9594439 ↗
• MalfunctionSep 16, 2019Break; Break

  IT WAS REPORTED THAT DURING USE THE INITIAL PLACEMENT KIT TROCAR BROKE OFF INSIDE THE PATIENT. THERE WAS NO REPORTED INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9069599 ↗
• MalfunctionMay 24, 2019Break; Break

  IT WAS REPORTED THE SUTURES BROKE DURING INSERTION. THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED 03-MAY-2019 STATED AN ADDITIONAL SET OF SAF-T-PEXY'S WERE USED TO COMPLETE THE PROCEDURE, THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8639939 ↗
• MalfunctionApr 22, 2019Break; Break

  IT WAS REPORTED THAT TWO OF THE SAFE-T-PEXY ANCHORS BROKE. PER ADDITIONAL INFORMATION RECEIVED 15 APR 2019, THE ANCHORS BROKE TOWARDS THE END OF THE GASTROSTOMY BUTTON PROCEDURE. THE FIRST ONE BROKE AT THE TIME OF THE PROBE INTRODUCTION, AND THE SECOND ONE BROKE AT THE END OF THE PROCEDURE. THERE WAS NO OTHER INTERVENTION REQUIRED. THE PATIENT CAME OUT OF THE PROCEDURE WITH JUST ONE ANCHOR. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8536641 ↗
• MalfunctionDec 19, 2018Break; Break

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2018-00233 FOR THE FIRST PATIENT. IT WAS REPORTED THAT THE THREAD OF A GASTROINTESTINAL ANCHOR SET SNAPPED THE NEXT DAY FOLLOWING A GASTROSTOMY OPERATION. THE THREAD SNAPPED AT TWO POSITIONS. IT WAS NOTED THAT THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8179565 ↗
• MalfunctionDec 19, 2018Break; Break

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2018-00234 FOR THE SECOND PATIENT. IT WAS REPORTED THAT THE THREAD OF A GASTROINTESTINAL ANCHOR SET SNAPPED THE NEXT DAY FOLLOWING A GASTROSTOMY OPERATION. THE THREAD SNAPPED AT ALL THREE POSITIONS. IT WAS NOTED THAT THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8179562 ↗
• MalfunctionDec 14, 2018Break; Break

  IT WAS REPORTED THAT THE THREAD OF A GASTROINTESTINAL ANCHOR SET SNAPPED DURING A PROCEDURE AND THE T-BAR FELL INTO THE PATIENT'S STOMACH. NO REPORTED PATIENT INJURY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8163837 ↗
• MalfunctionOct 26, 2018Break; Break

  IT WAS REPORTED THE "T-FASTENER SUTURES BROKE DURING A G-TUBE PLACEMENT." NO MEDICAL INTERVENTION WAS REQUIRED AND THE CLINICIANS WERE GOING TO TRY PLACING THE DEVICE AGAIN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8009008 ↗
• MalfunctionSep 10, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE INITIAL MIC-G TUBE PLACEMENT, USING THE INITIAL PLACEMENT KIT (IPK) THE PHYSICIAN WENT TO RETRACT THE INNER SLEEVES AND MAIN CATHETER OF THE DILATOR. LEAVING ONLY THE PEEL AWAY SHEATH, THE INNER SLEEVES DID NOT EXIT THE BODY WITH THE MAIN CATHETER. THE PHYSICIAN HAD TO USE A SNARE TO GRAB THE SLEEVES AND PULL THEM UP AND OUT WITH A SCOPE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 7860792 ↗
• MalfunctionMay 10, 2018Break; Break

  IT WAS REPORTED THAT 2 T-FASTENERS BROKE AFTER PLACEMENT. ONLY 2 OF THE 4 FASTENERS WERE USED, AND BOTH BROKE AFTER THE DILATOR WAS IN PLACE. THE PHYSICIAN ENDED UP PLACING THE FEEDING TUBE WITHOUT THE USE OF THE T-FASTENERS. THERE WAS NO PATIENT INJURY OR INTERVENTION REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7501862 ↗
• InjuryJan 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE DILATOR CAUSED A BOWEL PERFORATION. THIS WAS THE PHYSICIAN'S FIRST TIME USING THE DEVICE. THE OPERATION BEGAN AT 4:00PM. THE OPERATING PHYSICIAN HAD NO IDEA HOW DEEP HE SHOULD HAVE ADVANCED THE DILATOR INTO THE STOMACH. THE OPERATING PHYSICIAN FOCUSED MORE ON THE DILATOR WHICH HE WAS ADVANCING, HE COULD NOT RECOGNIZE THAT THE OUTER PART OF THE DILATOR HELD BY ANOTHER HAND WAS SLIDING TOWARD THE STOMACH. THE DILATOR WAS ADVANCED TOO MUCH AND PERFORATED THE POSTERIOR WALL OF THE STOMACH. THERE WAS NO BLEEDING. THE PERFORATION WAS ENDOSCOPICALLY CLIPPED. A COMPUTED TOMOGRAPHY (CT) WAS PERFORMED TO CONFIRMED CLOSURE. THE PHYSICIAN DECIDED TO DELAY THE START OF ENTERAL FEEDING FOR A WEEK. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Bowel Perforation

  MAUDE report 7222409 ↗
• MalfunctionOct 19, 2017Break; Break

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO PATIENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2017-00136 FOR THE FIRST PATIENT. IT WAS REPORTED THAT THE SUTURE BROKE 24-48 HOURS AFTER PLACEMENT. ADDITIONAL INFORMATION WAS RECEIVED 29SEP2017 THAT STATES TWO OF THE THREE SUTURES BROKE. THERE WAS NO INJURY AND NO MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6963337 ↗
• MalfunctionOct 19, 2017Break; Break

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO PATIENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2017-00137 FOR THE SECOND PATIENT. IT WAS REPORTED THAT THE SUTURE BROKE DURING PATIENT TRANSPORT TO FLOOR. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6963331 ↗
• InjuryApr 25, 2017Migration or Expulsion of Device; Device Operates Differently Than Expected; Migration or Expulsion of Device; Device Operates Differently Than Expected

  IT WAS REPORTED THAT AFTER RECEIVING A GASTROSTOMY ON (B)(6) 2016, THE PATIENT EXPERIENCED HIGH FEVER AND ABDOMINAL PAIN. X RAY ON (B)(6) 2016 SHOWED FREE GAS. AN EXPLORATORY LAPAROTOMY WAS PERFORMED, AND AN ANCHOR SUTURE FROM THE GASTROSTOMY PROCEDURE WAS FOUND PERFORATING THE STOMACH WALL. THE PERFORATION WAS SEWN OVER AND THE PATIENT RECOVERED FROM THE SURGERY. THE PATIENT LATER DIED AS A RESULT OF THEIR CANCER. THE TYPE OF CANCER WAS NOT REPORTED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Abdominal Pain; Fever; Perforation

  MAUDE report 6521215 ↗
• MalfunctionMar 2, 2017Break; Break

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE KITS, INVOLVING THE SAME PATIENT DURING THE SAME PROCEDURE. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2017-00032 FOR THE FIRST REPORT. IT WAS REPORTED THAT DURING A GASTRONOMY TUBE PLACEMENT, FOLLOWING THE FAILURE OF THE SUTURES FROM THE FIRST KIT, SUTURES FROM A SECOND KIT WERE USED. ALL OF THE SUTURES FROM THE SECOND KIT ALSO BROKE DURING PLACEMENT. A TOTAL OF SIX SUTURES FROM TWO KITS WERE ALLEGED TO HAVE BROKEN. ANOTHER KIT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS SOME STOMACH DISCHARGE DURING THE PROCEDURE DUE TO DERMAL PERFORATION. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: Perforation

  MAUDE report 6373031 ↗
• MalfunctionMar 2, 2017Break; Break

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE KITS, INVOLVING THE SAME PATIENT DURING THE SAME PROCEDURE. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2017-00033 FOR THE SECOND REPORT. IT WAS REPORTED THAT DURING A GASTRONOMY TUBE PLACEMENT, ALL OF THE SUTURES PLACED FROM THE FIRST KIT BROKE DURING PLACEMENT THERE WAS SOME STOMACH DISCHARGE DURING THE PROCEDURE DUE TO DERMAL PERFORATION. ANOTHER KIT WAS USED. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: Perforation

  MAUDE report 6373021 ↗