Halyard 98437Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10680651984378), received between Feb 2, 2017 and Apr 17, 2020 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 17, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE SUTURE "MADE THE HOLE TO THE STOMACH LARGER" AND "AIR HAVE LEAKED TO THE PERITONEUM." THE PATIENT, A CHILD, REQUIRED SURGERY. ADDITIONAL DETAILS: THE PROCEDURE WAS PERFORMED ON ((B)(6) 2020 AND THE PLACEMENT "LOOKED GOOD." THE PATIENT STARTED HAVING STOMACH ACHES, AND A NEW X RAY WAS PERFORMED ON (B)(6) 2020, WHICH SHOWED FREE GAS IN THE ABDOMEN, REQUIRING SURGERY. THE AIR LEAK HAD OCCURRED ALONG ONE ANCHOR SUTURE, AND THE SUTURE WAS "CHAFING BIGGER HOLES IN THE STOMACH THAN IT SHOULD." PER THE REPORTER, "WE HAVE NOT FULLY UNDERSTOOD THE PATIENT'S UNDERLYING DISEASES, WHICH IS WHY THIS HAPPENED TO EVERYTHING ELSE." PER ADDITIONAL INFORMATION RECEIVED 08 APR 2020, THE PATIENT HAS AN UNDERLYING AND UNUSUAL TISSUE PROBLEM/DISEASE, AND THE HEALTHCARE PROVIDED DOES NOT BELIEVE THE DEVICE FAILED.

  Patient problems: Abdominal Pain; No Code Available; Pocket Erosion

  MAUDE report 9974070 ↗
• MalfunctionOct 17, 2019Break; Break

  IT WAS REPORTED THAT THE T FASTENERS FELL OFF AFTER A FEW DAYS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9204348 ↗
• MalfunctionNov 28, 2018Break; Break

  IT WAS REPORTED THAT A T-FASTENER BROKE OFF IN THE PATIENT'S STOMACH AND THE STRING WAS NOT ATTACHED ON TWO OF THEM. THE DEVICE WAS SWITCHED OUT TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8109825 ↗
• MalfunctionNov 16, 2018Break; Break

  A REPORT WAS RECEIVED STATING DURING A PROCEDURE, THE HEALTHCARE PROVIDER ATTEMPTED TO UTILIZE THE SAF-T-PEXY. HOWEVER, WHEN DEPLOYED, THE T-FASTENERS BROKE. THERE WAS NO REPORTED INJURY, OR ASSOCIATED MEDICAL INTERVENTION. ADDITIONAL INFORMATION RECEIVED 30-OCT-2018 STATED THIS EVENT OCCURRED DURING INITIAL INSERTION, THE SUTURE BROKE AT THE SUTURE LOCK. THERE WAS NO PATIENT INJURY AND THE DEVICE WAS REPLACED WITH A NEW SAF-T-PEXY KIT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8081303 ↗
• MalfunctionFeb 2, 2017Break; Break

  IT WAS REPORTED THAT TWO OF THE THREE T-FASTENERS BROKE JUST AFTER PLACEMENT ON THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED ON 20-JAN-2017 THAT STATED, THE FIRST T-BAR WAS NOTED TO BE BROKEN WHILE CLEANING THE SKIN FOLLOWING COMPLETION OF THE PROCEDURE. THE ATTENDING PHYSICIAN DISCOVERED THE SECOND T-BAR FELL OFF WHEN THE PATIENT WAS IN THE POST ANESTHESIA CARE UNIT (PACU). THE GASTRO JEJUNOSTOMY (GJ) CATHETER WAS IN PLACE AND FUNCTIONING FINE, AND THE PATIENT CONTINUED TO RECEIVE FEEDINGS THROUGH THE DEVICE. THE PATIENT REMAINED ADMITTED IN THE HOSPITAL, BUT THIS WAS DUE TO THE ISSUES WHICH WERE NECESSITATED BY HIS GJ. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6298586 ↗