Halyard 98432Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10680651984323), received between Feb 2, 2017 and Nov 6, 2023 — classified as 3 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2023Migration; Migration

  IT WAS REPORTED A "GASTROSTOMY OPERATION WITH VENTROSCOPY WAS PERFORMED. AT THAT TIME THE PATIENT'S STOMACH WAS PULLED UP WITH A DEVICE LIKE FORCEPS TO MAKE A GASTRIC STOMA SITE. AFTER THE OPERATION, T-BAR WAS MIGRATED. ANCHOR WAS CUT AND THE T-BAR WAS REMOVED WITH AN ENDOSCOPE AND FIXED WITH SUTURE INSTEAD. (SUTURE WAS ALREADY REMOVED) NOW THERE IS NO PROBLEM WITH ADMINISTERING NUTRITION."

  Patient problems: Foreign Body In Patient

  MAUDE report 18074943 ↗
• InjuryNov 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A "GASTROSTOMY OPERATION WITH VENTROSCOPY WAS PERFORMED IN (B)(6) 2023. ONE OF T-BAR AREA WAS INFECTED, AND THE T-BAR WAS REMOVED IN (B)(6) 2023...THE INCIDENT WAS FOUND DURING FOLLOW-UP FOR A HOMECARE PATIENT AFTER THE GASTROSTOMY OPERATION. THE OPERATION WAS PERFORMED TO FIX THE STOMACH POSITION BETTER. GASTRIC STOMA SITE WAS COMPLETED AND THERE WAS NO PROBLEM FOR ADMINISTERING NUTRITION. DETAILS OF TREATMENT FOR INFECTION IS UNKNOWN."

  Patient problems: Skin Infection

  MAUDE report 18074938 ↗
• InjuryApr 24, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER THE SUCCESSFUL INITIAL PLACEMENT PROCEDURE FOR A GASTRIC-JEJUNAL FEEDING TUBE, THE PATIENT EXPERIENCED PAINT 6 DAYS LATER. A CT SCAN WAS PERFORMED AND SHOWED A FOREIGN BODY IN THE ABDOMEN. SURGERY WAS PERFORMED AND THE FOREIGN BODY WAS DETERMINED TO BE A PIECE OF THE TELESCOPING DILATOR FROM THE PLACEMENT KIT USED IN THE PROCEDURE. THE PIECE WAS REMOVED FROM THE PATIENT. PER ADDITIONAL INFORMATION RECEIVED (B)(6) 2020, AS OF THIS DATE THE PATIENT WAS READY TO BE DISCHARGED. THE TUBE THAT HAD BEEN INSERTED WAS A 16FR GASTRO-JEJUNAL (GJ) TUBE. THE FRAGMENT FOUND INSIDE THE PATIENT WAS APPROXIMATELY 9FR IN DIAMETER. IT HAD SOMEHOW BECOME SEPARATED FROM THE DEVICE AND HAD BEEN EXTRUDED INTO THE BOWEL DURING THE PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque; Internal Organ Perforation

  MAUDE report 9998110 ↗
• MalfunctionFeb 14, 2020Break; Break

  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 9611594-2020-00024 FOR THE FIRST REPORT. REFER TO 9611594-2020-00028 FOR THE THIRD REPORT. IT WAS REPORTED THAT THE SUTURES BROKE DURING PLACEMENT. THREE KITS TOTAL WERE OPENED TO USE ON ONE PATIENT. NO INJURY TO THE PATIENT WAS REPORTED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9712676 ↗
• MalfunctionFeb 14, 2020Break; Break

  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 9611594-2020-00027 FOR THE SECOND REPORT . REFER TO 9611594-2020-00028 FOR THE THIRD REPORT . IT WAS REPORTED THAT THE SUTURES BROKE DURING PLACEMENT. THREE KITS TOTAL WERE OPENED TO USE ON ONE PATIENT. NO INJURY TO THE PATIENT WAS REPORTED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9712675 ↗
• MalfunctionFeb 14, 2020Break; Break

  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 9611594-2020-00024 FOR THE FIRST REPORT. REFER TO 9611594-2020-00027 FOR THE SECOND REPORT. IT WAS REPORTED THAT THE SUTURES BROKE DURING PLACEMENT. THREE KITS TOTAL WERE OPENED TO USE ON ONE PATIENT. NO INJURY TO THE PATIENT WAS REPORTED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9712674 ↗
• MalfunctionDec 13, 2019Break; Break

  IT WAS REPORTED THAT AFTER THE PROCEDURE, ONE OF THE ANCHORS FELL OUT WHILE THE PATIENT WAS IN THE RECOVERY ROOM. IT WAS CONFIRMED BY THE GASTROENTEROLOGIST THAT THE SUTURE HAD BROKEN. WHILE CLEANING UP THE OPERATING ROOM, A SECOND ANCHOR WAS FOUND WITH A BROKEN SUTURE. THERE WAS NO INJURY TO THE PATIENT. PER ADDITIONAL INFORMATION RECEIVED ON 28 NOV 2019, THE PATIENT IS AWAKE AND NOT IN PAIN. THE PATIENT IS BEING MONITORED, AND THE GASTROSTOMY TUBE REMAINS IN PLACE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9465814 ↗
• MalfunctionDec 13, 2019Break; Break

  IT WAS REPORTED THAT DURING PLACEMENT, ONE OF THE ANCHORS BROKE DURING THE DILATION STEP. NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9465792 ↗
• MalfunctionOct 21, 2019Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, ALL FOUR T FASTENERS FAILED. ANOTHER KIT WAS OPENED TO USE THE T-FASTENERS AND COMPLETE THE PROCEDURE. THE PROCEDURE WAS PERFORMED UNDER LOCAL ANESTHESIA. NO INJURY TO THE PATIENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9215819 ↗
• MalfunctionAug 26, 2019Break; Break

  ADDITIONAL INFORMATION RECEIVED 21AUG2019 INDICATED THAT "A NEW INTERVENTION WAS NOT NECESSARY."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8930875 ↗
• MalfunctionApr 5, 2019Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE, TWO OF THE ANCHORS BROKE. NO FURTHER INFORMATION PROVIDED AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8486578 ↗
• MalfunctionMar 16, 2019Break; Break

  IT WAS REPORTED THAT TWO OF THE ANCHORS PROVIDED IN THE INTRODUCER KIT BROKE DURING PLACEMENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8426877 ↗
• MalfunctionJul 12, 2018Break; Break

  IT WAS REPORTED THAT AFTER PLACEMENT OF THE ANCHORS, THREE OF THEM DID NOT STAY FIXED. ANOTHER KIT WAS OPENED TO COMPLETE THE PROCEDURE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7681128 ↗
• MalfunctionFeb 28, 2017Break; Break

  IT WAS REPORTED THAT DURING A RADIOLOGICALLY INSERTED PERCUTANEOUS GASTROSTOMY PROCEDURE, THE SERIAL DILATOR FROM THE KIT WOULD NOT RELEASE FROM THE PEEL AWAY SHEATH. ONLY THE CENTRAL PORTION WITH THE WHITE CAP COULD BE REMOVED, AND THE REST OF THE DILATOR REMAINED WITHIN THE PEEL AWAY SHEATH. THE PEEL AWAY SHEATH AND THE DILATOR WERE REMOVED OVER THE WIRE AND A SECOND KIT OPENED SO A REPLACEMENT DILATOR / PEEL AWAY SHEATH COULD BE USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. ON EXAMINATION OF THE FAULTY DILATOR, THE TAPERED GREY END BETWEEN THE WHITE TIP AND THE RED DILATOR WAS MISSING. THE HOSPITAL IS NOT SURE IF THE PIECE WAS RETAINED IN THE PATIENT'S STOMACH, OR WAS STUCK IN THE SERIAL DILATOR. THE PATIENT HAS SUFFERED NO ILL EFFECTS AND DOES NOT REQUIRE ANY FOLLOW UP, AND HAS BEEN DISCHARGED FROM THE HOSPITAL. THE DOCTOR DOES NOT BELIEVE THE PIECE WAS RETAINED IN THE PATIENT. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient

  MAUDE report 6366478 ↗
• InjuryFeb 20, 2017Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT A DILATOR BECAME STUCK INSIDE THE PEEL OFF CATHETER DURING PLACEMENT. THE DILATOR REMAINED INSIDE THE ABDOMEN, AND GOT PUSHED INSIDE THE STOMACH WHEN THE TUBE WAS PLACED. A SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE DILATOR PIECE. NO FURTHER INFORMATION HAS BEEN RECEIVED AT THIS TIME.

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 6343866 ↗
• MalfunctionFeb 2, 2017Break; Break

  THE FOLLOWING FDA USER FACILITY REPORT WAS RECEIVED FOR (B)(4) WITH AN ALERT DATE: 15-FEB-2017. "TUBE WAS PLACE SUCCESSFULLY UTILIZING THE HALYARD INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE. A POST PROCEDURE C-ARM CT NOTED A FILLING DEFECT WITHIN THE GASTRIC BODY LYING SOMEWHAT TRANSVERSELY WHICH APPEARED TO BE A BROKEN PORTION OF THE DILATOR CONTAINED IN THE KIT. A LOOP AND TRI-LOBED SNARE AND NG WERE USED TO GRASP THE FRAGMENT AND GENTLY RETRACT IT INTO THE ESOPHAGUS WITHOUT DIFFICULTY. IN THE UPPER ESOPHAGUS, THE LOOP SNARE BECAME DISENGAGED AND REPEATED ATTEMPTS COULD NOT CAPTURE THE CRANIAL END OF THE DILATOR IN THE UPPER ESOPHAGUS. UNDER DIRECT VISUALIZATION THROUGH AN ENDOSCOPE, THE DILATOR PORTION WAS ENTIRELY RETRIEVED." THE DATE OF EVENT WAS UPDATED TO (B)(6) 2017. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6298584 ↗