Halyard 98430Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10680651984309), received between Feb 3, 2017 and Apr 9, 2020 — classified as 1 injury, 19 malfunctions.

The most frequently reported specific device problem is “Break” (18 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 9, 2020Break; Break

  IT WAS REPORTED THAT THE SUTURES BROKE ON THREE ANCHORS WHILE THE SURGEON WAS PLACING THEM. THERE WAS NO INJURY TO THE PATIENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9946813 ↗
• MalfunctionJul 23, 2019Break; Break

  IT WAS REPORTED THAT "ONE OF THE SUTURES BROKE WHEN THE DILATOR WAS INSERTED INTO THE STOMA AFTER THE SUTURES BEING PLACED." NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8815523 ↗
• MalfunctionApr 3, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT AFTER HAVING AN INITIAL BUTTON PLACEMENT IN (B)(6) 2018, IN (B)(6) 2019 A SMALL METAL ROD FROM THE SUTURE BUTTON WAS REMOVED FROM THE SITE. IT'S POSSIBLE TO FEEL THE SAME METAL ROD ON THE SITE OF THE TWO OTHER SUTURES. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 8480820 ↗
• MalfunctionJan 16, 2019Break; Break

  IT WAS REPORTED THAT A DOCTOR PERFORMED A RADIOLOGICALLY INSERTED GASTROSTOMY AND MANAGED TO OPEN TWO OF THE GASTROSTOMY FEEDING TUBES WITH AN ANCHOR SET DUE TO THE FASTENERS CONTINUOUSLY BREAK/SNAPPING/CUTTING WHEN HE TRIED TO ANCHOR THE SAF-T-PEXY T-FASTENERS. NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8253866 ↗
• MalfunctionDec 21, 2018Break; Break

  IT WAS REPORTED THAT THE SUTURES PROVIDED IN THE KIT SNAPPED DURING THE PROCEDURE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8191479 ↗
• MalfunctionDec 14, 2018Break; Break

  IT WAS REPORTED THAT THERE WAS AN ANCHOR FAILURE WITH A GASTROSTOMY KIT. THE SUTURES, WHICH ARE SUPPOSED TO LAST UNTIL THE SECOND OR THIRD WEEK AFTER PLACEMENT, HAVE FALLEN OFF THE SAME DAY THEY WERE PLACED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8163834 ↗
• MalfunctionNov 28, 2018Break; Break

  IT WAS REPORTED THAT THE SAF-T-PEXY FASTENERS KEPT SNAPPING DURING THE PROCEDURE, AND THE FEEDING TUBE HAD TO BE ANCHORED IN WITH SEPARATE SUTURES. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8109828 ↗
• MalfunctionNov 20, 2018Break; Break

  IT WAS INITIALLY REPORTED THAT THERE WAS AN ISSUE WITH "FAULTY BUTTONS." NO FURTHER INFORMATION WAS PROVIDED AT THE TIME. ADDITIONAL INFORMATION RECEIVED ON 05-NOV-2018 STATED THAT THE SUTURES SNAPPED ON INSERTION UNDER NO PRESSURE OR TENSION. NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8090768 ↗
• MalfunctionOct 25, 2018Break; Break

  IT WAS REPORTED THAT DURING A ROUTINE DEPLOYMENT OF MIC ANCHOR GASTROPEXY SUTURES AS PART OF A RADIOLOGICALLY INSERTED GASTROSTOMY (RIG) PROCEDURE, ALL FOUR ANCHOR SUTURES PROVIDED IN THE KIT FAILED TO MAINTAIN ADEQUATE TENSION AND SNAPPED AT VARIOUS STATES OF THE PROCEDURE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8006424 ↗
• MalfunctionOct 19, 2018Break; Break

  IT WAS REPORTED THAT THE SUTURES SNAPPED. ON OF THE CLIPS THAT SECURES THE DISC IN PLACE CAME OFF THE SUTURE. ALL OF THE SUTURES PROVIDED IN THE KIT SNAPPED DURING USE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7986241 ↗
• MalfunctionOct 15, 2018Break; Break

  IT WAS REPORTED THAT THE ANCHORS PROVIDED IN THE KIT SNAPPED IN HALF WHEN DEPLOYED. THERE WAS NO INJURY TO THE PATIENT. NEW ANCHORS WERE USED WITHOUT FURTHER INCIDENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7964629 ↗
• MalfunctionOct 12, 2018Break; Break

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS USED ON THE SAME PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 9611594-2018-00184 FOR THE FIRST REPORT. IT WAS REPORTED THAT THE SUTURES SNAPPED DURING PLACEMENT IN RADIOLOGY. NO INJURY TO PATIENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7959933 ↗
• MalfunctionOct 12, 2018Break; Break

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS USED ON THE SAME PATIENT. THIS IS THE FIRST OF TWO REPORTS. REFER TO 9611594-2018-00185 FOR THE SECOND REPORT. IT WAS REPORTED THAT THE SUTURES SNAPPED DURING PLACEMENT IN RADIOLOGY. NO INJURY TO PATIENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7959883 ↗
• MalfunctionOct 1, 2018Break; Break

  IT WAS REPORTED THAT THE T-FASTENERS IN THE KIT BREAK AND "JUMP OFF' AFTER PLACEMENT. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7923857 ↗
• MalfunctionSep 26, 2018Break; Break

  IT WAS REPORTED THAT THE SUTURES BROKE UPON INSERTION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7909325 ↗
• MalfunctionAug 1, 2018Break; Break

  HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 9611594-2018-00106 FOR THE FIRST PATIENT. REFER TO 9611594-2018-00107 FOR THE SECOND PATIENT. IT WAS REPORTED THAT AFTER PLACEMENT, ONE SUTURE BROKE DUE TO ALLEGED "SUTURE WEAKNESS." NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7740572 ↗
• MalfunctionAug 1, 2018Break; Break

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 9611594-2018-00106 FOR THE FIRST PATIENT. REFER TO 9611594-2018-00108 FOR THE THIRD PATIENT. IT WAS REPORTED THAT AFTER PLACEMENT, ONE SUTURE BROKE DUE TO ALLEGED "SUTURE WEAKNESS." NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7738893 ↗
• MalfunctionAug 1, 2018Break; Break

  AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 9611594-2018-00107 FOR THE SECOND PATIENT. REFER TO 9611594-2018-00108 FOR THE THIRD PATIENT. IT WAS REPORTED THAT AFTER PLACING SUTURES DURING AN UNEVENTFUL GASTROSTOMY PROCEDURE DONE UNDER GASTROSCOPY AND LAPAROSCOPY, ALL THREE T FASTENERS FAILED DUE TO BREAKING OF THE SUTURES. AN ADDITIONAL PROCEDURE MAY BE REQUIRED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7738881 ↗
• MalfunctionMay 29, 2017Break; Break

  IT WAS REPORTED THAT THE DILATOR IN THE KIT SNAPPED DURING THE PROCEDURE, AND A PIECE OF THE DEVICE REMAINED IN THE PATIENT'S ABDOMEN. THE HOSPITAL WAS UNABLE TO REMOVE THE PIECE DURING THE PROCEDURE, AND WILL REQUIRE AN ENDOSCOPY TO REMOVE. PER ADDITIONAL INFORMATION RECEIVED, THE RETAINED DILATOR WAS REMOVED SUCCESSFULLY WITH ENDOSCOPY AND THE PATIENT IS CURRENTLY FINE. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6597205 ↗
• InjuryFeb 3, 2017Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THREE TO FOUR WEEKS FOLLOWING PLACEMENT OF THE SUTURES, THE EXTERNAL BUMPERS FELL OFF NORMALLY BUT THE INTERNAL ANCHORS REMAINED IN PLACE AND CAUSED PAIN. SURGERY WAS REQUIRED TO REMOVE THE ANCHORS. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 6299597 ↗