Argyle 43201Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884527005079), received between Dec 13, 2020 and Jun 10, 2021 — classified as 1 death, 4 malfunctions.

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

• MalfunctionJun 10, 2021Difficult to Open or Close; Difficult to Open or Close

  THE CUSTOMER REPORTED THAT THE #11 SAFETY SCALPEL IS ALWAYS DIFFICULT TO DISENGAGE AND THEY HAVE REPORTED A USER CUTTING THEIR FINGERS WHEN ATTEMPTING TO DISENGAGE THE SAFETY DEVICE.

  Patient problems: Laceration(s)

  MAUDE report 11974143 ↗
• MalfunctionMay 27, 2021Difficult to Open or Close; Difficult to Open or Close

  CUSTOMER REPORTS: THE #11 SAFETY SCALPEL IN THE KIT WILL NOT DISENGAGE THE SAFETY DEVICE FOR THE SCALPEL TO BE USED. ANOTHER TRAY WAS USED AND THE SAFETY DEVICE DISENGAGED NORMALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11897645 ↗
• MalfunctionMay 27, 2021Difficult to Open or Close; Difficult to Open or Close

  THE CUSTOMER REPORTED THAT THE SCALPEL IN THE TRAY IS HARD TO OPEN/DIS-ENGAGE WHICH IS CAUSING A SAFETY HAZARD. ADDITIONAL INFORMATION PROVIDED STATED THAT THE SCALPEL, WHICH WAS A SAMPLE, WAS EXTREMELY HARD TO OPEN AND WAS NOT USED. NO INJURIES OCCURRED AND THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11894684 ↗
• MalfunctionDec 13, 2020Mechanical Problem; Mechanical Problem

  THE CUSTOMER STATED THAT THEY OPENED A SET AND HAD THE STAFF PRACTICE OPENING THE SCALPEL AND THERE WERE NO ISSUES UNTIL ONE PERSON PUSHED UP HARD ON THE PLASTIC CAP AND IT (SCALPEL) APPEARED TO LOCK SHUT AGAIN. NO PATIENT WAS INVOLVED DURING THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10997278 ↗
• DeathDec 13, 2020Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THAT DURING AN EMERGENCY SITUATION THE SCALPEL IN THE UVC SET APPEARED LOCKED AND WAS UNABLE TO BE OPENED BY THE PROVIDERS DURING A NEONATAL CODE SITUATION. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER ON (B)(6) 2020 STATED THAT THERE WAS LESS THAN A MINUTE OF A DELAY IN INSERTING THE UVC LINE DURING AN ADVANCED RESUSCITATION IN A C-SECTION. THE NEWBORN EXPIRED. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER ON (B)(6) 2020 STATED THAT THEY COULD NOT PULL THE SCALPELS SAFETY SHEATH DOWN, STATING THAT IT WAS LOCKED IN". THE CUSTOMER STATED THAT SINCE THE INCIDENT OCCURRED IN AN EMERGENCY SITUATION, SHE DOES NOT KNOW IF THE SCALPEL WAS ALREADY IN THE LOCKED POSITION WHEN REMOVED FROM THE UVC KIT. SHE STATED THAT THEY USED A DIFFERENT SCALPEL THAT THEY GOT FROM THE OR TABLE AS A REPLACEMENT TO PLACE THE LINE. THE CUSTOMER WOULD NOT ANSWER IF THEY BELIEVED THAT THE ISSUE WITH THE DEVICE CAUSED OR CONTRIBUTED TO THE PATIENTS DEATH. THE CUSTOMER STATED THAT ALL SHE WILL SAY IS THAT THE BABY WAS IN FETAL DISTRESS WHICH IS WHY THEY NEEDED TO PLACE THE UVC LINE. NO FURTHER INFORMATION WILL BE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 10997272 ↗