AccuCath Ace AC1202252Recalls & reported problems

Summary

The FDA's MAUDE database contains 59 adverse event reports that list this exact device (DI 00801741138010), received between Aug 5, 2020 and Sep 23, 2026 — classified as 5 injuries, 54 malfunctions.

The most frequently reported specific device problem is “Activation Problem” (32 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 25 most recent of 59 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Activation Problem

  It was reported having problems safety their AccuCaths. 20G specifically happening way more frequently. Causing for more sticks on already difficult access patient. Severe impact on care and treatment, injury to patient for having to get another needle stick because they have to pull out the initially started, IV. Impacted the workflow of the clinician as well. No further information was provided.It was reported this occurred with nine devices. This report addresses all nine devices.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50863226 ↗
• MalfunctionSep 23, 2026Activation Problem

  It was reported having problems with the safety their AccuCath 20G. Caused additional stick on already difficult access patient. Severe impact on care and treatment, injury to patient for having to get another needle stick because they have to pull out the initially started, IV. Impacted the workflow of the clinician as well. No further information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50863222 ↗
• MalfunctionMar 26, 2026Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED AN ACCUCATH WAS PLACED FOR A CARDIAC CTA WITH CONTRAST ADMINISTRATION. THE ACCUCATH BEGAN LEAKING AT THE HUB DURING CONTRAST INJECTION. ASSESSMENT SHOWED THE CATHETER HAD TWISTED AT THE INSERTION SITE WHILE SECURED WITH A STATLOCK, THOUGH THE PIGTAIL CONNECTION WAS CONFIRMED TO BE SECURE. NO INFILTRATION OCCURRED, AND THE CONTRAST LEAKED EXTERNALLY FROM THE HUB AND THE CATHETER WAS NOTED TO BE TWISTED INTERNALLY AT THE INSERTION SITE BUT FULLY INTACT WITH NO PORTION RETAINED IN THE PATIENT. THE IV WAS REMOVED AND A NEW ACCUCATH WAS PLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24702408 ↗
• MalfunctionMar 26, 2026Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED THAT AN ACCUCATH WAS PLACED TO COMPLETE A CARDIAC CTA EXAM. DURING MONITORING THE HUB LEAKAGE OCCURRED. WHEN THE DRESSING WAS REMOVED, IT WAS NOTED THAT THE CATHETER HAD TWISTED WITHIN THE STATLOCK DEVICE BUT NOT TO THE DEGREE AS THE FIRST ACCUCATH. THE STATLOCK WAS REMOVED, THE CATHETER REMAINED PATENT WITH BLOOD RETURN, AND IT FLUSHED EASILY WITH 20 ML NS. THE IV WAS THEN SECURED WITH TAPE INSTEAD OF A STATLOCK, AFTER WHICH NO FURTHER LEAKAGE OCCURRED AND THE EXAM WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24702403 ↗
• MalfunctionMar 10, 2026Product Quality Problem; Difficult to Remove

  IT WAS REPORTED BY THE CUSTOMER THAT THE WIRE COULD NOT BE RETRACTED ONCE IT WAS INSIDE THE VEIN. NO PATIENT HARM. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES BOTH DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24559070 ↗
• MalfunctionFeb 17, 2026Difficult to Insert; Activation Problem

  IT WAS REPORTED BY THE CUSTOMER THAT AN NURSE INSERTED AN ACCUCATH INTO A VEIN WITH SIGNIFICANT CURVATURE. IT WAS REPORTED THAT THE GUIDEWIRE INITIALLY DEPLOYED ONLY HALFWAY, SO IT WAS RETRACTED AND REALIGNED, AFTER WHICH THE GUIDEWIRE ADVANCED NORMALLY. WHEN THE NURSE PRESSED THE BUTTON TO RETRACT THE NEEDLE, THE NEEDLE RETRACTED EXCEPT FOR THE DISTAL PORTION. THE NURSE REMOVED THE DEVICE AND NOTED A DEFORMED NEEDLE TIP. THE NURSE LATER RECALLED THAT THERE WAS SCAR TISSUE AT THE ANTECUBITAL AREA AND THAT INSERTING THE NEEDLE HAD BEEN DIFFICULT. NO INJURIES TO THE PATIENT REPORTED. NO FURTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24370743 ↗
• MalfunctionJan 22, 2026Difficult to Insert; Product Quality Problem

  IT WAS REPORTED THAT UPON EJECTION OF CATHETER, WIRE WAS STUCK AND NOT ABLE TO BE PULLED OUT WITHOUT REMOVING CATHETER. HAD TO RE-STICK WITH ANOTHER ACCUCATH. NO FURTHER DETAILS AVAILABLE OR PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24152289 ↗
• MalfunctionJan 13, 2026Component Missing

  IT WAS REPORTED BY CUSTOMER THAT NEEDLE BROKEN WHEN PACKAGE OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24060416 ↗
• MalfunctionNov 21, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED ACCUCATH KIT WAS OPENED AND CATHETER WAS BENT WITHIN THE CASING. CATHETER HAD BEEN PULLED UP AND BENT OUT OF SHAPE. NO OTHER INFORMATION WAS PROVIDED. (B)(6) 2025 IT WAS FOUND DURING AN INVESTIGATION THE NEEDLE TO BE AT AN ANGLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23619743 ↗
• MalfunctionOct 30, 2025Product Quality Problem; Activation Problem; Product Quality Problem; Activation Problem

  IT WAS REPORTED THAT ISSUES WITH NEEDLE RETRACTION, LEADING TO ADDITIONAL STICK. THE NEEDLE RETRACTION FAILURE WAS DURING PATIENT USE. THE CATHETER WOULD NOT ADVANCE AND THE CATHETER WAS REMOVED FROM THE PATIENT. WHEN THE NURSE PUSHED THE BUTTON TO RETRACT, ABOUT 1CM OF THE NEEDLE WOULD NOT RETRACT BACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23424608 ↗
• MalfunctionSep 18, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT CUSTOMER EXPERIENCED ISSUES WITH THE SAFETY TRIGGER NOT ACTIVATING. NO ADDITIONAL INFORMATION PROVIDED. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23084948 ↗
• MalfunctionSep 17, 2025Activation Problem; Activation Problem

  IT WAS REPORTED, ISSUES WITH THE SAFETY NEEDLE TRIGGER NOT ACTIVATING. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23072862 ↗
• MalfunctionSep 17, 2025Activation Problem; Activation Problem

  IT WAS REPORTED ISSUES WITH THE SAFETY NEEDLE TRIGGER NOT ACTIVATING. NO OTHER INFORMATION WAS PROVIDED. THE EXACT NUMBER OF DEVICES OR PATIENTS INVOLVED WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23072717 ↗
• MalfunctionAug 18, 2025Material Deformation; Material Deformation

  IT WAS REPORTED ACCUCATH WAS ACCURATELY PLACED IN THE CENTER OF THE VEIN, THERE WAS BLOOD RETURN IN THE CATHETER BUT IT WOULD NOT FLUSH. THE NURSE CONFIRMED THE PLACEMENT WITH ULTRASOUND BUT TOOK THE IV OUT BECAUSE IT WOULDN'T FLUSH. SHE THEN TRIED TO FLUSH IT OUTSIDE OF THE PATIENT AND FLUID WAS STOPPED IN THE HUB. NO OTHER INFORMATION WAS PROVIDED. 08/06/2025- IT WAS FOUND DURING AN INVESTIGATION THREE SIGNIFICANT KINKS WERE OBSERVED ALONG THE CATHETER SHAFT FROM BENDING OF THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22829841 ↗
• MalfunctionJun 30, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED, WHEN WE TOOK THE ACCUCATH OUT OF THE PACKAGE IT WAS BENT TO THE LEFT AND WHEN THE SAFETY WAS HIT THE NEEDLE DIDN'T RETRACT AND IT STAYED OUTSIDE. IT DID NOT IMPACT THE PATIENT. SHE OPENED THE PACKAGING AND GOT EVERYTHING SET UP. WHEN SHE POPPED OFF THE CAP TO THE ACCUCATH IT LOOKED OFF TO ME. SHE RESTARTED AND OPENED ANOTHER ACCUCATH KIT INSTEAD. 06/10/2025: THE RETURNED DEVICE EXHIBITED A BENT NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22352657 ↗
• MalfunctionJun 13, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED PATIENT REQUIRED AN ACCUCATH PLACEMENT. THE EXTENSION TUBING DOES NOT FULLY LOCK IN WHEN TWISTED AND THEN THERE ARE ISSUES DRAWING BLOOD DUE TO GETTING AIR PULLED BACK. I HAVE CHECKED WITH ULTRASOUND AFTER PLACEMENT TO ENSURE THAT WE ARE IN FACT IN THE VEIN AND EVERY TIME THE IV HAS BEEN IN THE APPROPRIATE SPOT. I HAVE TRIED USING DIFFERENT EXTENSION TUBING TO FIX THE PROBLEM, OTHER THAN THE ONE THAT COMES IN THE KIT, BUT IT DOES NOT FULLY TWIST ON EITHER CAUSING AIR LEAK. THERE WAS NO HARM, INJURY, COMPLICATION, OR NEGATIVE OUTCOME AS A RESULT. THE CUSTOMER REPORTED THIS HAS OCCURRED MULTIPLE TIMES HOWEVER AN EXACT QUANTITY OF DEVICES OR PATIENTS INVOLVED WAS NOT PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22205316 ↗
• MalfunctionMay 23, 2025Difficult to Insert; Material Deformation; Difficult to Insert; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT "NURSE ATTEMPTED TO PLACE A ACCUCATH, HOWEVER THE WIRE THREADED INITIALLY BUT THE CATHETER WOULD NOT ADVANCE. NURSE ATTEMPTED TO REMOVE FULL DEVICE AT ONE TIME BUT IT WOULD NOT COME OUT. DESPITE NEEDLE RETRACTING IT WAS SHOWN THAT THE WIRE WAS NOT COMING OUT UNDER X RAY." THE GUIDEWIRE DID NOT BREAK. DEVICE REMOVED BY IR PHYSICIAN, ADDED FORCE. THERE WAS NO DELAY AND NO HARM. NEW CATHETER WAS PLACED IN THE OTHER ARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22079297 ↗
• MalfunctionAug 13, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY CUSTOMER THAT AFTER INSERTING AN ACCUCATH 20G 2.25 INCH CATHETER, IT WOULD NOT FLUSH. NURSE ATTEMPTED TO REMOVE AND WHEN ALMOST COMPLETELY OUT, CATHETER COULD NOT BE REMOVED FROM THE VEIN/SKIN. SURGEON CALLED TO REMOVE SO AS NOT TO DAMAGE CATHETER. SURGEON ABLE TO PULL OUT AND THE TIP OF CATHETER WAS KINKED. ADDITIONAL INFORMATION 07/25/2024: IT WAS REPORTED BY THE CUSTOMER "THE PATIENT DID NOT HAVE CATHETER REMOVED SURGICALLY. THE SURGEON WAS ABLE TO PULL IT OUT. I AM NOT AWARE IF THE PATIENT HAD ANY SUBSEQUENT ADVERSE EVENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19977163 ↗
• MalfunctionAug 8, 2024Activation Problem; Activation Problem

  IT WAS REPORTED, "ACCUCATH NEEDLE FAILED TO RETRACT INTO HOUSING WHEN SAFETY BUTTON WAS PRESSED. DID NOT AFFECT PATIENT, PROCEDURE WAS ALREADY HALTED FOR UNRELATED REASONS. AFTER THE ACCUCATH WAS REMOVED FROM THE PROCEDURAL AREA, I ATTEMPTED TO PUSH THE SAFETY BUTTON WITH NO RESPONSE. WHEN I GENTLY PULLED ON THE NEEDLE (AWAY FROM THE HOUSING), THE SAFETY THEN ACTIVATED AND THE NEEDLE RETRACTED INTO THE HOUSING." ADDITIONAL INFORMATION RECEIVED 07/23/2024: THERE WAS NO INJURY TO PATIENT OR PROVIDER REPORTED, AND NO ADDITIONAL TREATMENT NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19940984 ↗
• MalfunctionJul 1, 2024Activation Problem; Activation Problem

  IT WAS REPORTED THAT ACCUCATH ACE 20GA 2.25IN NEEDLE WOULD NOT RETRACT (SAFETY) AFTER INSERTION. NO ACTUAL IMPACT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19645814 ↗
• MalfunctionJun 19, 2024Failure to Infuse; Failure to Infuse

  IT WAS REPORTED, HAD A NURSE PLACE A MIDLINE TODAY AND ATTEMPT AN ACCUCATH. HE HAD ISSUES WITH THE MIDLINE NOT FLUSHING AND ENDED UP REMOVING THE LINE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19567982 ↗
• MalfunctionMay 20, 2024Activation Problem; Activation Problem

  IT WAS REPORTED BY CUSTOMER THAT, "I OPENED A PACKAGE THIS MORNING TO INSERT AN ACCUCATH ON A PATIENT AND FOUND A DEFECTIVE CATHETER. THE CAP WAS NOT SNAPPED ON AND THE NEEDLE HAD BEEN RETRACTED." NO OTHER INFORMATION WAS PROVIDED. (B)(6) 2024 - THE RETURNED DEVICE EXHIBITED THE NEEDLE RETRACTED AND THE CAP DECOUPLED FROM THE NEEDLE ASSEMBLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19351811 ↗
• MalfunctionMay 7, 2024Material Twisted/Bent; Activation Problem; Material Twisted/Bent; Activation Problem

  IT WAS REPORTED, "OPENED KIT TO FIND NEEDLE & CATHETER AT A SEVERE ANGLE. IT WAS NOT USED ON A PATIENT, A BBRAUN CATHETER WAS PULLED AND USED INSTEAD. WHEN THE SAFETY WAS EVENTUALLY ACTIVATED THE NEEDLE DID NOT RETRACT AND THE WIRE WAS STICKING OUT THE END OF IT." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19265845 ↗
• MalfunctionMay 6, 2024Activation Problem; Activation Problem

  IT WAS REPORTED, "OPENED KIT TO FIND NEEDLE AND CATHETER AT AN ANGLE. I WAS ABLE TO PUSH THE NEEDLE INTO ALIGNMENT AND THEN IT RETRACTED FULLY." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19248183 ↗
• MalfunctionApr 9, 2024Activation Problem; Activation Problem

  IT WAS REPORTED, THE INSERTION WAS FINE WITHOUT ANY ISSUE. VISUALIZED WITHIN THE VEIN, ADVANCED THE GUIDEWIRE WITHOUT ANY PROBLEM. THE VESSEL ITSELF WAS A NICE HEALTHY, LARGE AND EASILY COMPRESSIBLE VEIN. WHEN THEY PUSHED THE SAFETY BUTTON, THE BUTTON DEPRESSED BUT DID NOT RETRACT THE NEEDLE. THEY SAID THEY WERE STILL PARALLEL TO THE PATIENT'S ARM/VEIN SO IT SHOULD HAVE RETRACTED EASILY AS THEY NORMALLY DO. THEY HAD TO PULL THE ENTIRE NEEDLE OUT OF THE CATHETER IN ORDER FOR IT TO RETRACT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19072132 ↗