Halyard 98431Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10680651984316), received between Jul 23, 2017 and Nov 22, 2023 — classified as 35 malfunctions.

The most frequently reported specific device problem is “Break” (28 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 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 22, 2023Premature Separation; Premature Separation

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING ONE PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2023-00169 FOR THE FIRST REPORT. IT WAS REPORTED, T-BAR CAME OFF. IT WAS SUPPOSED THAT THE SUTURE SNAPPED AT THE CONNECTION PART BETWEEN T-BAR AND THE SUTURE. NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18193854 ↗
• MalfunctionNov 22, 2023Premature Separation; Premature Separation

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING ONE PATIENT. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2023-00170 FOR THE SECOND REPORT. IT WAS REPORTED, T-BAR CAME OFF AFTER A FEW HOURS OF OPERATION. IT WAS SUPPOSED THAT THE SUTURE SNAPPED AT THE CONNECTION PART BETWEEN T-BAR AND THE SUTURE. NO INJURY OR MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 18193849 ↗
• MalfunctionSep 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED " AFTER [THE] GASTROSTOMY OPERATION WAS PERFORMED, IT BLED FROM THE POSTERIOR GASTRIC WALL. THOUGH INSUFFLATION TO PATIENT'S STOMACH [WAS PERFORMED] THE DISTANCE BETWEEN STOMACH WALL AND ABDOMINAL WALL...DID NOT GET CLOSER. [THE CLINICIAN] PULLED [THE] STOMACH WITH FUNADA GASTROPEXY DEVICE USING FORCEPS UNDER LAPAROSCOPE." WHEN THE "DILATOR WAS USED, IT TOUCHED THE POSTERIOR GASTRIC WALL AND IT BLED FROM THERE. NOW THE PATIENT IS RECOVERING."

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17765800 ↗
• MalfunctionJun 20, 2023Migration; Migration

  IT WAS REPORTED ¿AFTER FIXING THE GASTRIC WALL WITH GASTROPEXY, THE T-FASTENER CAME OUT FROM THE BODY SURFACE SEVERAL WEEKS AFTER THE OPERATION. WHEN THE T FASTENER CAME OUT OF THE BODY SURFACE, IT WAS REMOVED, AND THERE WAS NO PARTICULAR HEALTH HAZARD. NECESSITY OF REPLACEMENT: UNNECESSARY.¿ NO INJURY REPORTED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17164931 ↗
• MalfunctionApr 16, 2020Break; Break

  PER ADDITIONAL INFORMATION RECEIVED 5 MAY 2020, A NEW KIT WAS REQUIRED TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9967501 ↗
• MalfunctionMar 13, 2020Break; Break

  IT WAS REPORTED THAT TWO ANCHORS WERE "LOST" AFTER ONE DAY. THERE WAS NO INJURY TO THE PATIENT. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9829503 ↗
• MalfunctionFeb 26, 2020Fracture; Fracture

  IT WAS REPORTED THAT "SEVERAL STRINGS WHICH ARE HOLDING (ARE SUPPOSED TO HOLD) THE ANCHORS IN PLACE WERE CUT AND OPEN SURGERY WAS NECESSARY. THE STRINGS WERE CUT FROM THE BASE OF THE ANCHORS." CUSTOMER RESPONDED THAT THEY DO NOT HAVE ANY ADDITIONAL INFORMATION ON THE CASE AND HAVE NOT RECEIVED ANY FOLLOW-UP AFTER THE OPEN SURGERY.

  Patient problems: No Code Available

  MAUDE report 9756653 ↗
• MalfunctionFeb 14, 2020Fracture; Fracture

  IT WAS REPORTED THAT TWO SUTURES BROKE UPON PLACEMENT. PER ADDITIONAL INFORMATION RECEIVED 24 JAN 2020, THE PROCEDURE TOOK PLACE IN DECEMBER. PER THE REPORTED INFORMATION, "THE PATIENT IS PROBABLY DISCHARGED NOW." NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9712665 ↗
• MalfunctionMay 23, 2019Break; Break

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE FOURTH OF FOUR REPORTS. REFER TO 9611594-2019-00101 FOR THE FIRST REPORT. REFER TO 9611594-2019-00102 FOR THE SECOND REPORT. REFER TO 9611594-2019-00103 FOR THE THIRD REPORT. IT WAS REPORTED THAT "T-ANCHORS TEAR IN PART ALREADY AT THE PLACEMENT OR SHORTLY AFTER SETTING THE T-ANCHOR (WITHIN DAYS)." NO PATIENT INJURY REPORTED. EVENT OCCURRED WITHIN THE "LAST TWO MONTHS." ADDITIONAL INFORMATION RECEIVED ON 08-MAY-2019 INDICATED THAT A NEW KIT WAS OPENED TO COMPLETE THE CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8637793 ↗
• MalfunctionMay 23, 2019Break; Break

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE THIRD OF FOUR REPORTS. REFER TO 9611594-2019-00101 FOR THE FIRST REPORT. REFER TO 9611594-2019-00102 FOR THE SECOND REPORT. REFER TO 9611594-2019-00104 FOR THE FOURTH REPORT. IT WAS REPORTED THAT "T-ANCHORS TEAR IN PART ALREADY AT THE PLACEMENT OR SHORTLY AFTER SETTING THE T-ANCHOR (WITHIN DAYS)." NO PATIENT INJURY REPORTED. EVENT OCCURRED WITHIN THE "LAST TWO MONTHS." ADDITIONAL INFORMATION RECEIVED ON 08-MAY-2019 INDICATED THAT A NEW KIT WAS OPENED TO COMPLETE THE CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8637788 ↗
• MalfunctionMay 23, 2019Break; Break

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE SECOND OF FOUR REPORTS. REFER TO 9611594-2019-00101 FOR THE FIRST REPORT. REFER TO 9611594-2019-00103 FOR THE THIRD REPORT. REFER TO 9611594-2019-00104 FOR THE FOURTH REPORT. IT WAS REPORTED THAT "T-ANCHORS TEAR IN PART ALREADY AT THE PLACEMENT OR SHORTLY AFTER SETTING THE T-ANCHOR (WITHIN DAYS)." NO PATIENT INJURY REPORTED. EVENT OCCURRED WITHIN THE "LAST TWO MONTHS." ADDITIONAL INFORMATION RECEIVED ON 08-MAY-2019 INDICATED THAT A NEW KIT WAS OPENED TO COMPLETE THE CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8637787 ↗
• MalfunctionMay 23, 2019Break; Break

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT PATIENTS. THIS IS THE FIRST OF FOUR REPORTS. REFER TO 9611594-2019-00102 FOR THE SECOND REPORT. REFER TO 9611594-2019-00103 FOR THE THIRD REPORT. REFER TO 9611594-2019-00104 FOR THE FOURTH REPORT. IT WAS REPORTED THAT "T-ANCHORS TEAR IN PART ALREADY AT THE PLACEMENT OR SHORTLY AFTER SETTING THE T-ANCHOR (WITHIN DAYS)." NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED ON 08-MAY-2019 INDICATED THAT A NEW KIT WAS OPENED TO COMPLETE THE CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8637786 ↗
• MalfunctionMay 15, 2019Break; Break

  IT WAS REPORTED THAT DURING THE GASTROPEXY PROCEDURE, ALL THREE SUTURES FROM THE KIT BROKE. A NEW KIT WAS OPENED IN ORDER TO COMPLETE THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8614010 ↗
• MalfunctionMar 13, 2019Break; Break

  AVANOS MEDICAL, INC. 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 9611594-2019-00042 FOR THE SECOND EVENT. IT WAS REPORTED THAT ONE SUTURE FELL OFF DAY-1 POST INSERTION. THERE WAS NO REPORTED INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8419193 ↗
• MalfunctionMar 13, 2019Break; Break

  AVANOS MEDICAL, INC. 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 9611594-2019-00041 FOR THE FIRST EVENT. IT WAS REPORTED SECOND SUTURE FELL OFF DAY-2 AFTER PLACEMENT. THERE WAS NO REPORTED INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8419192 ↗
• MalfunctionMar 13, 2019Break; Break

  IT WAS REPORTED 1 SUTURE STAY FELL OFF ON DAY OF PROCEDURE. THERE WAS NO REPORTED INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8419189 ↗
• MalfunctionMar 13, 2019Break; Break

  IT WAS REPORTED 2 SUTURE STAYS FELL OFF DAY 1 POST INSERTION. THERE WAS NO REPORTED INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8419188 ↗
• MalfunctionJan 3, 2019Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT THE SUTURE TORE DURING THE PROCEDURE AND A NEW KIT HAD TO BE OPENED TO ACCESS THE SAF-T-PEXY FASTENERS NEEDED TO COMPLETE THE PROCEDURE. NO PATIENT INJURY. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8211837 ↗
• MalfunctionDec 14, 2018Break; Break

  PER THE ADDITIONAL INFORMATION RECEIVED 17-DEC-2018 STATED THE PRODUCT AND LOT CHANGES WERE PROVIDED BY THE CUSTOMER AND NOT FROM AN ERROR IN THE INITIAL REPORT. THE LOT NUMBER PROVIDED WAS NOT A VALID LOT NUMBER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8165755 ↗
• MalfunctionDec 4, 2018Break; Break

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING AN UNKNOWN NUMBER OF PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 9611594-2018-00220 FOR THE FIRST EVENT. REFER TO 9611594-2018-00221 FOR THE SECOND EVENT. IT WAS REPORTED BY THE DISTRIBUTOR THAT THE T-FASTENERS ARE BREAKING WHEN THE STOMACH IS PULLED UPWARDS. THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8130485 ↗
• MalfunctionDec 4, 2018Break; Break

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING AN UNKNOWN NUMBER OF PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 9611594-2018-00221 FOR THE SECOND EVENT. REFER TO 9611594-2018-00222 FOR THE THIRD EVENT. IT WAS REPORTED BY THE DISTRIBUTOR THAT THE T-FASTENERS ARE BREAKING WHEN THE STOMACH IS PULLED UPWARDS. THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8128353 ↗
• MalfunctionDec 4, 2018Break; Break

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING AN UNKNOWN NUMBER OF PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 9611594-2018-00220 FOR THE FIRST EVENT. REFER TO 9611594-2018-00222 FOR THE THIRD EVENT. IT WAS REPORTED BY THE DISTRIBUTOR THAT THE T-FASTENERS ARE BREAKING WHEN THE STOMACH IS PULLED UPWARDS. THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8128334 ↗
• MalfunctionNov 21, 2018Break; Break

  AVANOS MEDICAL, INC. 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 9611594-2018-00212 FOR THE FIRST EVENT. IT WAS REPORTED THAT SOME OF THE SUTURES FROM A KIT TORE DURING THE PROCEDURE, AND A NEW INTRODUCER KIT HAD TO BE OPENED AND USED. THERE WAS NO INJURY REPORTED. PER ADDITIONAL INFORMATION RECEIVED 12-NOV-2018, THREE OF THE SUTURES IN THE FIRST KIT BROKE DURING THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8097591 ↗
• MalfunctionNov 21, 2018Break; Break

  AVANOS MEDICAL, INC. 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 9611594-2018-00213 FOR THE SECOND EVENT. IT WAS REPORTED THAT SOME OF THE SUTURES FROM A KIT TORE DURING THE PROCEDURE, AND A NEW INTRODUCER KIT HAD TO BE OPENED AND USED. THERE WAS NO INJURY REPORTED. PER ADDITIONAL INFORMATION RECEIVED 12-NOV-2018, TWO OF THE SUTURES IN THE FIRST KIT BROKE DURING THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8097586 ↗
• MalfunctionNov 20, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT THREE T-FASTENERS MIGRATED TO THE GASTRIC MUCOSA ON AN INFANT'S STOMACH AND CAUSED PAIN. A GASTROSTOMY PROCEDURE WAS PERFORMED ON (B)(6) 2018. A LAPAROSCOPE AND ENDOSCOPE WERE USED FOR THE GASTROSTOMY WITH THREE ANCHORS SET. THE INSIDE OF THE STOMACH WAS DEAERATED BY A DOCTOR. THERE WERE NO NOTED PROCEDURAL ISSUES. THE ANCHORS AND T-FASTENERS REMAINED THROUGH THE MIDDLE OF SEPTEMBER. THE DOCTOR WOULD CHECK THE INSIDE OF THE STOMACH DURING NEXT REPLACEMENT OF THE CATHETER. THE PATIENT EXPERIENCED PAIN. A CT SCAN WAS PERFORMED AND IT WAS NOTED THREE T-FASTENERS MIGRATED TO GASTRIC MUCOSA AND THIS WAS THE CAUSE OF THE PAIN. THE POSITIONS OF T-FASTENER WERE NOTED AS FOLLOWS: SEROUS MEMBRANE IN THE STOMACH, INSIDE OF THE PERITONEUM, ONE CAME OUT OF SUBCUTIS WITH PAIN. THE T-FASTENERS WERE REMOVED AT 11AM ON (B)(6) 2018. THE CLINICAL COURSE IS AS FOLLOWS: ON (B)(6) 2018: THE PATIENT UNDERWENT GASTROSTOMY USING AN INTRODUCER KIT UNDER ENDOSCOPIC AND LAPAROSCOPIC GUIDANCE. THE STOMACH AND GASTRIC WALL WAS FIXED AT 3 POINTS. ON (B)(6) 2018: THE PATIENT VISITED OUTPATIENT DEPARTMENT OF THE HOSPITAL. ALL THE ANCHORS WERE RETAINED ON THE SKIN, SO THE SURGEON REMOVED THE AN

  Patient problems: Pain

  MAUDE report 8091046 ↗