Halyard 40778Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10680651407785), received between Jul 12, 2017 and Apr 16, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 16, 2020Break; Break

  PROCEDURE: TOTAL KNEE PROCEDURE. CATHPLACE: ADDUCTOR CANAL. IT WAS REPORTED, "ANESTHESIA PLACED A FEMORAL ADDUCTOR CANAL BLOCK FOR A TOTAL KNEE PROCEDURE. AT THE DESIGNATED TIME TO REMOVE, THE POST-OP NURSE WAS UNABLE TO PULL THE CATHETER OUT. ONE OF ANESTHESIA PROVIDERS ATTEMPTED TO REMOVE. IT WAS DIFFICULT AND THEN THE CATHETER BROKE. AN X-RAY REVEALED THAT SOME PORTION OF THE CATHETER REMAINED. THE PROVIDER CONSULTED WITH [THE] (ANESTHESIA -PAIN) PHYSICIAN. THE PATIENT WAS TAKEN TO A PROCEDURE ROOM WHERE THE REMAINDER OF THE CATHETER WAS REMOVED UNDER FLUOROSCOPIC GUIDANCE." THE CATHETER TIP APPEARED INTACT WHEN IT WAS REMOVED. THE PATIENT TOLERATED THE REMOVAL PROCEDURE "WELL" AND NO COMPLICATIONS WERE ENCOUNTERED.

  Patient problems: Foreign Body In Patient

  MAUDE report 9970197 ↗
• MalfunctionFeb 22, 2018Break; Break

  IT WAS REPORTED THAT WHILE PLACING THE CATHETER FROM A T-BLOC TRAY (WITH EPI-MED CATHETER) FOR A NERVE BLOCK FOR A TOTAL KNEE SURGERY, THE CATHETER BROKE. WHILE THE CATHETER WAS BEING THREADED THROUGH, THE CATHETER BECAME KINKED, AND WAS PULLED BACK OUT. WHEN IT WAS PULLED OUT, IT WAS NOTED THAT THE TIP OF THE CATHETER HAD SHEARED OFF. IT IS UNKNOWN HOW MUCH OF THE CATHETER WAS LEFT INSIDE THE PATIENT. THE CATHETER DID APPEAR STRETCHED. THE PATIENT WAS RE-BLOCKED WITH A NEW CATHETER WITH NO FURTHER ISSUES. THE PATIENT IS IN STABLE CONDITION. PER ADDITIONAL INFORMATION RECEIVED 9 FEB 2018, 4-5CM OF CATHETER WITH METAL WAS LEFT IN THE PATIENT. IT IS LOCATED IN THE HIP AREA. THE PATIENT WAS GIVEN A CHOICE OF SURGICAL REMOVAL, OR TO LEAVE IT IN AND TAKE ANTIBIOTICS. THE PATIENT HAS ELECTED LEAVE THE CATHETER PIECE IN. PER ADDITIONAL INFORMATION RECEIVED 13 FEB 2018, THE CATHETER WAS FOR A CONTINUOUS FEMORAL BLOCK. NO FURTHER INFORMATION HAS BEEN RECEIVED AT THIS TIME.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7290746 ↗
• MalfunctionJul 12, 2017Break; Break

  FILL VOLUME: UNKNOWN, FLOW RATE: UNKNOWN, PROCEDURE: SHOULDER PROCEDURE, CATHPLACE: INTERSCALENE. IT WAS REPORTED THE CATHETER WAS THREADED THROUGH THE NEEDLE. WHEN THE ANESTHESIOLOGIST TRIED TO REMOVE THE NEEDLE AND GUIDEWIRE, THE CATHETER BROKE AT THE TIP. A SECOND TRAY WAS OPENED AND THE BLOCK WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED 15-JUNE-2017 STATED THE CATHETER BROKE INSIDE THE PATIENT. THE BROKEN CATHETER SEGMENT REMAINED INSIDE THE PATIENT. NO FURTHER INFORMATION TO BE PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6708774 ↗