AccuCath Ace AC1221252Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741137990), received between Oct 22, 2021 and May 4, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Activation Problem” (11 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 4, 2026Activation Problem

  IT WAS REPORTED THE NEEDLE WILL NOT DISENGAGE. PATIENT WAS DIFFICULT TO STICK. PEDIATRIC PATIENT REQUIRED ADDITIONAL ULTRASOUND NEEDLE STICK. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25075990 ↗
• MalfunctionAug 2, 2023Activation Problem; Activation Problem

  IT WAS REPORTED BY THE CUSTOMER "UPON NOTIFYING SUPERVISOR, HE REPORTED HE HAD ALSO HEARD FROM SEVERAL OTHERS TRAINED THAT THEY HAVE EXPERIENCED THIS OCCASIONALLY WHERE THE NEEDLE DOES NOT RETRACT COMPLETELY INTO THE SAFETY CHAMBER. STAFF MEMBER REPORTS HE HAS DONE ABOUT 16 SINCE TRAINING AND IT HAS HAPPENED AT LEAST 2 TIMES. OTHER TEAM MEMBERS TRAINED ALSO WERE REPORTING THIS BUT DID NOT LET LEADERSHIP KNOW UNTIL THIS WEEK. THESE TEAM MEMBERS RANGE FROM EMERGENCY, TRANSPORT, AND FLEX. EACH TEAM MEMBER HAVING EXPERIENCED THIS OCCUR ON A PATIENT AT LEAST ONCE. UNSURE IF USER ERROR OR MANUFACTURING CONCERN. CONCERN IS IF THERE IS AN ISSUE WITH THE ACTUAL SAFETY MECHANISM OR ARE WE HAVING SMALL USER ERRORS WHEN IT COMES TO PRESSING THE SAFETY BUTTON AND REMOVING GUIDE-WIRE AT THE SAME TIME. SUPERVISOR XXX ALSO CALLED MAIN ED AND RN AT MAIN CAMPUS WHO ALSO REPORT THIS OCCURRING BUT ARE UNSURE IF THIS IS USER ERROR OR MANUFACTURING ISSUE AS IT HAPPENS OCCASIONALLY. NURSES HAVE ALSO REPORTED IT HAS HAPPENED WITH ALL SIZE CATHETERS WE USE SUCH AS THE 22G 1.25IN. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER "I DO NOT HAVE ANY MORE DETAILS TO SHARE. I HAVE FOLLOWED UP WITH A FEW NURSES

  Patient problems: Insufficient Information

  MAUDE report 17447082 ↗
• MalfunctionAug 2, 2023Activation Problem; Activation Problem

  IT WAS REPORTED THAT EVENT HAPPENED ON THE NIGHT OF (B)(6) 2023. WHEN PRESSING THE WHITE SAFETY BUTTON TO RETRACT NEEDLE, THE NEEDLE ONLY PARTIALLY RETRACTED AND HE COULD NOT REMOVE GUIDEWIRE/NEEDLE. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER "I DO NOT HAVE ANY MORE DETAILS TO SHARE. I HAVE FOLLOWED UP WITH A FEW NURSES WHO STATED THEY HAVE NOT HAD ANOTHER ISSUE WITH THE RETRACTOR BUTTON."

  Patient problems: Insufficient Information

  MAUDE report 17442843 ↗
• MalfunctionAug 2, 2023Activation Problem; Activation Problem

  IT WAS REPORTED BY THE CUSTOMER "UPON NOTIFYING SUPERVISOR, HE REPORTED HE HAD ALSO HEARD FROM SEVERAL OTHERS TRAINED THAT THEY HAVE EXPERIENCED THIS OCCASIONALLY WHERE THE NEEDLE DOES NOT RETRACT COMPLETELY INTO THE SAFETY CHAMBER. STAFF MEMBER REPORTS HE HAS DONE ABOUT 16 SINCE TRAINING AND IT HAS HAPPENED AT LEAST 2 TIMES. OTHER TEAM MEMBERS TRAINED ALSO WERE REPORTING THIS BUT DID NOT LET LEADERSHIP KNOW UNTIL THIS WEEK. THESE TEAM MEMBERS RANGE FROM EMERGENCY, TRANSPORT, AND FLEX. EACH TEAM MEMBER HAVING EXPERIENCED THIS OCCUR ON A PATIENT AT LEAST ONCE. UNSURE IF USER ERROR OR MANUFACTURING CONCERN. CONCERN IS IF THERE IS AN ISSUE WITH THE ACTUAL SAFETY MECHANISM OR ARE WE HAVING SMALL USER ERRORS WHEN IT COMES TO PRESSING THE SAFETY BUTTON AND REMOVING GUIDE-WIRE AT THE SAME TIME. SUPERVISOR XXX ALSO CALLED MAIN ED AND RN AT MAIN CAMPUS WHO ALSO REPORT THIS OCCURRING BUT ARE UNSURE IF THIS IS USER ERROR OR MANUFACTURING ISSUE AS IT HAPPENS OCCASIONALLY. NURSES HAVE ALSO REPORTED IT HAS HAPPENED WITH ALL SIZE CATHETERS WE USE SUCH AS THE 22G 1.25IN. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER "I DO NOT HAVE ANY MORE DETAILS TO SHARE. I HAVE FOLLOWED UP WITH A FEW NURSES

  Patient problems: Insufficient Information

  MAUDE report 17442700 ↗
• MalfunctionAug 2, 2023Activation Problem; Activation Problem

  IT WAS REPORTED BY THE CUSTOMER "UPON NOTIFYING SUPERVISOR, HE REPORTED HE HAD ALSO HEARD FROM SEVERAL OTHERS TRAINED THAT THEY HAVE EXPERIENCED THIS OCCASIONALLY WHERE THE NEEDLE DOES NOT RETRACT COMPLETELY INTO THE SAFETY CHAMBER. STAFF MEMBER REPORTS HE HAS DONE ABOUT 16 SINCE TRAINING AND IT HAS HAPPENED AT LEAST 2 TIMES. OTHER TEAM MEMBERS TRAINED ALSO WERE REPORTING THIS BUT DID NOT LET LEADERSHIP KNOW UNTIL THIS WEEK. THESE TEAM MEMBERS RANGE FROM EMERGENCY, TRANSPORT, AND FLEX. EACH TEAM MEMBER HAVING EXPERIENCED THIS OCCUR ON A PATIENT AT LEAST ONCE. UNSURE IF USER ERROR OR MANUFACTURING CONCERN. CONCERN IS IF THERE IS AN ISSUE WITH THE ACTUAL SAFETY MECHANISM OR ARE WE HAVING SMALL USER ERRORS WHEN IT COMES TO PRESSING THE SAFETY BUTTON AND REMOVING GUIDE-WIRE AT THE SAME TIME. SUPERVISOR XXX ALSO CALLED MAIN ED AND RN AT MAIN CAMPUS WHO ALSO REPORT THIS OCCURRING BUT ARE UNSURE IF THIS IS USER ERROR OR MANUFACTURING ISSUE AS IT HAPPENS OCCASIONALLY. NURSES HAVE ALSO REPORTED IT HAS HAPPENED WITH ALL SIZE CATHETERS WE USE SUCH AS THE 22G 1.25IN. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER "I DO NOT HAVE ANY MORE DETAILS TO SHARE. I HAVE FOLLOWED UP WITH A FEW NURSES

  Patient problems: Insufficient Information

  MAUDE report 17442697 ↗
• MalfunctionAug 2, 2023Activation Problem; Activation Problem

  IT WAS REPORTED BY THE CUSTOMER "UPON NOTIFYING SUPERVISOR, HE REPORTED HE HAD ALSO HEARD FROM SEVERAL OTHERS TRAINED THAT THEY HAVE EXPERIENCED THIS OCCASIONALLY WHERE THE NEEDLE DOES NOT RETRACT COMPLETELY INTO THE SAFETY CHAMBER. STAFF MEMBER REPORTS HE HAS DONE ABOUT 16 SINCE TRAINING AND IT HAS HAPPENED AT LEAST 2 TIMES. OTHER TEAM MEMBERS TRAINED ALSO WERE REPORTING THIS BUT DID NOT LET LEADERSHIP KNOW UNTIL THIS WEEK. THESE TEAM MEMBERS RANGE FROM EMERGENCY, TRANSPORT, AND FLEX. EACH TEAM MEMBER HAVING EXPERIENCED THIS OCCUR ON A PATIENT AT LEAST ONCE. UNSURE IF USER ERROR OR MANUFACTURING CONCERN. CONCERN IS IF THERE IS AN ISSUE WITH THE ACTUAL SAFETY MECHANISM OR ARE WE HAVING SMALL USER ERRORS WHEN IT COMES TO PRESSING THE SAFETY BUTTON AND REMOVING GUIDE-WIRE AT THE SAME TIME. SUPERVISOR XXX ALSO CALLED MAIN ED AND RN AT MAIN CAMPUS WHO ALSO REPORT THIS OCCURRING BUT ARE UNSURE IF THIS IS USER ERROR OR MANUFACTURING ISSUE AS IT HAPPENS OCCASIONALLY. NURSES HAVE ALSO REPORTED IT HAS HAPPENED WITH ALL SIZE CATHETERS WE USE SUCH AS THE 22G 1.25IN. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER "I DO NOT HAVE ANY MORE DETAILS TO SHARE. I HAVE FOLLOWED UP WITH A FEW NURSES

  Patient problems: Insufficient Information

  MAUDE report 17442696 ↗
• MalfunctionAug 2, 2023Activation Problem; Activation Problem

  IT WAS REPORTED BY THE CUSTOMER "UPON NOTIFYING SUPERVISOR, HE REPORTED HE HAD ALSO HEARD FROM SEVERAL OTHERS TRAINED THAT THEY HAVE EXPERIENCED THIS OCCASIONALLY WHERE THE NEEDLE DOES NOT RETRACT COMPLETELY INTO THE SAFETY CHAMBER. STAFF MEMBER REPORTS HE HAS DONE ABOUT 16 SINCE TRAINING AND IT HAS HAPPENED AT LEAST 2 TIMES. OTHER TEAM MEMBERS TRAINED ALSO WERE REPORTING THIS BUT DID NOT LET LEADERSHIP KNOW UNTIL THIS WEEK. THESE TEAM MEMBERS RANGE FROM EMERGENCY, TRANSPORT, AND FLEX. EACH TEAM MEMBER HAVING EXPERIENCED THIS OCCUR ON A PATIENT AT LEAST ONCE. UNSURE IF USER ERROR OR MANUFACTURING CONCERN. CONCERN IS IF THERE IS AN ISSUE WITH THE ACTUAL SAFETY MECHANISM OR ARE WE HAVING SMALL USER ERRORS WHEN IT COMES TO PRESSING THE SAFETY BUTTON AND REMOVING GUIDE-WIRE AT THE SAME TIME. SUPERVISOR ALSO CALLED MAIN ED AND RN AT MAIN CAMPUS WHO ALSO REPORT THIS OCCURRING BUT ARE UNSURE IF THIS IS USER ERROR OR MANUFACTURING ISSUE AS IT HAPPENS OCCASIONALLY. NURSES HAVE ALSO REPORTED IT HAS HAPPENED WITH ALL SIZE CATHETERS WE USE SUCH AS THE 22G 1.25IN. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER "I DO NOT HAVE ANY MORE DETAILS TO SHARE. I HAVE FOLLOWED UP WITH A FEW NURSES WHO

  Patient problems: Insufficient Information

  MAUDE report 17442534 ↗
• MalfunctionAug 1, 2023Activation Problem; Activation Problem

  IT WAS REPORTED, THAT ON THE MORNING OF (B)(6) 23. THE SUPERVISOR WAS NOTIFIED BY A TEAM MEMBER TRAINED IN ACCUCATH, THAT THERE WAS A MALFUNCTION WHEN USING THE DEVICE. THE TEAM MEMBER REPORTS HE WAS IN THE VEIN, THREADED THE GUIDE WIRE, AND THE CATHETER WENT IN SMOOTH "LIKE BUTTER" OVER THE GUIDE WIRE. AND WHEN HE PRESSED THE WHITE SAFETY BUTTON TO RETRACT NEEDLE, THE NEEDLE ONLY PARTIALLY RETRACTED, AND HE COULD NOT REMOVE GUIDEWIRE/NEEDLE. THE ENTIRE CATHETER HAD TO BE PULLED. AND THE PATIENT HAD TO BE RESTUCK, DUE TO ERROR. TEAM MEMBER FEELS IF NOT FOR THIS ISSUE, THE IV WOULD HAVE BEEN SUCCESSFUL ON INITIAL ATTEMPT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17437796 ↗
• MalfunctionAug 1, 2023Activation Problem; Activation Problem

  IT WAS REPORTED THAT THE NEEDLE DOES NOT RETRACT COMPLETELY INTO THE SAFETY CHAMBER. ON 7/12 A TEAM MEMBER HAD IT OCCUR IN TRAINING AND WAS TOLD TO JUST REMOVE THE ENTIRE LINE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17437555 ↗
• MalfunctionJul 6, 2022Activation Problem; Activation Problem

  IT WAS REPORTED "DURING ULTRASOUND GUIDED LONG PIV PLACEMENT THE GUIDEWIRE FAILED TO RETRACT AND WAS DIFFICULT TO REMOVE FROM PATIENT SKIN." ADDITIONAL INFORMATION RECEIVED 6/27/2022: THE GUIDEWIRE DIDN¿T RETRACT. THE GUIDEWIRE WAS STICKING OUT THE NEEDLE AFTER THE SAFETY WAS RETRACTED, THE SAFETY MECHANISM DIDN¿T FUNCTION PROPERLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14930659 ↗
• MalfunctionOct 26, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE GUIDEWIRE GOT HUNG UP ON THE CATHETER AND KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12697898 ↗
• MalfunctionOct 22, 2021Activation Problem; Activation Problem

  IT WAS REPORTED A CATHETER I PLACED ON A (B)(6) IN THE FOREARM THE GUIDE WIRE ADVANCED THERE WAS BLOOD RETURN IN THE CATHETER, THE CATHETER THREADED SMOOTH AND WHEN I HIT THE BUTTON THE GUIDE WIRE GOT HUNG UP ON THE CATHETER AND KINKED IT UNDER THE SKIN AND I HAD TO PULL BACK ON BOTH FOR THE NEEDLE TO FULLING RETRACT. PLACEMENT TECHNIQUE: ULTRASOUND GUIDED. WAS THERE ANY PATIENT HARM REPORTED? NO HARM, JUST ADDITIONAL NEEDLE POKE FOR PLACEMENT. WEIGHT: ABOUT (B)(6). WHAT THEY¿RE BEING TREATED FOR: WORK UP FOR ABDOMINAL PAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12683409 ↗