AccuCath Ace AC1202250Recalls & reported problems

Summary

The FDA's MAUDE database contains 153 adverse event reports that list this exact device (DI 00801741137952), received between Feb 19, 2020 and Aug 5, 2026 — classified as 17 injuries, 136 malfunctions.

The most frequently reported specific device problem is “Activation Problem” (55 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 153 reports, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2026Material Frayed

  It was reported, went to engage the safety on the Accucath and the needle/guide wire didn't retract. Ended up having to withdraw the catheter out of the vein, but then noticed the wire looked shorter and the curly cue at the end of the wire was not there. Provider is aware. X-ray is ordered.Didn't pull the wire back, wire was intact out of the package, and no resistance. When I hit the retract button, the portion you hold while inserting (the see through part) was pulled out of my fingers and pulled down to the patient. At that point the whole system was stuck but the portion you hold would slide backwards but the needle still would not retract. The needle all of the sudden did retract and then I noticed it didn't appear intact and pulled the catheter out.Additional Information received on 24-Jul-2026:No harm that we are aware of. Inserter acted quickly and appropriately in notifying the ED providers about the concern and further interventions. The patient had an x-ray of his forearm which showed a retained fragment. Vascular was consulted and the patient had an ultrasound/vascular study which did not show any fragmentation in the vasculature. The patient was admitted, the admittin

  Patient problems: Foreign Body In Patient

  MAUDE report 50141138 ↗
• MalfunctionJul 10, 2026Activation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25781935 ↗
• MalfunctionMay 19, 2026Fluid/Blood Leak

  IT WAS REPORTED PLASTIC CATH SPLITTING. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25218573 ↗
• MalfunctionMay 13, 2026Activation Problem

  IT WAS REPORTED BY CUSTOMER THAT "AFTER THE NEEDLE ENTERED THE BLOOD VESSEL, THEY TRIED TO ADVANCE THE GUIDEWIRE, BUT IT WOULD NOT MOVE AT ALL, ALSO WHEN THEY PRESSED THE BUTTON TO RETRACT THE NEEDLE, THAT MECHANISM JAMMED, AND THE NEEDLE DID NOT RETRACT AS DESIGNED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25161070 ↗
• MalfunctionMay 6, 2026Activation Problem

  IT WAS REPORTED THAT ACCUCATH ACE DEVICES FAILED TO RETRACT THE NEEDLE WHEN THE BUTTON WAS DEPRESSED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25102575 ↗
• MalfunctionMay 5, 2026Material Frayed

  IT WAS REPORTED BY MEDWATCH ULTRASOUND GUIDED IV PLACEMENT WAS PERFORMED. WHEN RN RETRACTED THE GUIDE WIRE, SHE MET RESISTANCE BUT WAS ABLE TO REMOVE IT. UPON REMOVING THE GUIDE WIRE, THE RN NOTICED THE CURLED END OF THE WIRE WAS MISSING. SHE DID NOT INFUSE ANYTHING THROUGH THE IV AND IMMEDIATELY NOTIFIED THE PHYSICIAN. PHYSICIAN CAME TO THE BEDSIDE AND REMOVED THE CATHETER WITHOUT INCIDENT. IMAGING WAS ORDERED. PARTIALLY IMAGED LINEAR DENSITY ALONG THE RADIAL ASPECT OF THE PROXIMAL FOREARM, MAY REFLECT AN IV OR CALCIFICATION CANNOT EXCLUDE RETAINED FOREIGN BODY IN THE PROPER SETTING, X-RAYS PERFORMED ON RIGHT FOREARM. RESULT: NO ACUTE ABNORMALITIES. XRAY PERFORMED ON RIGHT HUMERUS. RESULT: NO ACUTE ABNORMALITIES.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 25086824 ↗
• MalfunctionApr 22, 2026Material Frayed

  IT WAS REPORTED THAT DURING THE PLACEMENT OF THE SECOND PIV IN THE LEFT FOREARM USING A 20-GAUSE ACCUCATH, THE VEIN WAS ACCESS, AND THE INTEGRATED GUIDEWIRE AND CATHETER WERE ADVANCED. THE NEEDLE RETRACTED NORMALLY; HOWEVER, THE GUIDEWIRE INITIALLY MET RESISTANCE DURING REMOVAL. THE GUIDEWIRE AND CATHETER WERE ULTIMATELY REMOVED TOGETHER, AND THE CATHETER WAS NOTED TO BE COILED, WITH THE GUIDEWIRE TIP APPEARING TO BE MISSING. A TOURNIQUET WAS APPLIED IMMEDIATELY. THE PATIENT REPORTED NO PAIN AND REMINED IN NO DISTRESS. THE FIRST CALL WAS TO MD, WHO THEN CONSULTED INTERVENTIONAL RADIOLOGY (IR). IMAGING OF THE CHEST AND LEFT FOREARM WAS ORDERED AND REVIEWED IN REAL TIME BY THE IR PROVIDER. A POINT-OF-CARE ULTRASOUND WAS PERFORMED. RADIOGRAPHIC IMAGES WERE TAKEN OF THE ELBOW, HUMERUS, AND CHEST, WHICH DID NOT DEMONSTRATE ANY FOREIGN BODY PRESENT. THE FIRST-CALL PROVIDER AND THE INTERVENTIONAL RADIOLOGIST WERE SHOWN THE MALFUNCTIONING DEVICE ALONGSIDE AN UNUSED ACCUCATH FOR COMPENSATION. UPON EXAMINATION OF THE IV,, THERE WAS A LESS THAN 1MM PORTION OF THE WIRE THAT WAS NOT PRESENT. THIS WAS NOT VISUALIZED ON THE IMAGING; HOWEVER, IF IT WERE RETAINED, IT IS NOT LIKELY TO BE CLINICALLY

  Patient problems: Foreign Body In Patient

  MAUDE report 24960557 ↗
• MalfunctionApr 22, 2026Product Quality Problem

  IT WAS REPORTED SNAGGED GUIDEWIRE. THE GUIDEWIRE IS ABLE TO THREAD THROUGH THE NEEDLE AND CATCHES WHEN ATTEMPTING TO REMOVE IT. ON THE 18G MAINLY, UNABLE TO RETRACT THE NEEDLE AFTER GUIDEWIRE IS ADVANCED WHILE ADVANCING THE CATHETER. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24952854 ↗
• MalfunctionMar 13, 2026Activation Problem

  IT WAS REPORTED VIA MEDWATCH, RN ATTEMPTED TO PLACE ACCUCATH IV. SAFETY MECHANISM DID NOT DEPLOY TO PULL THE NEEDLE BACK INTO THE DEVICE. NO ADVERSE EVENTS OR INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24597407 ↗
• MalfunctionFeb 24, 2026Activation Problem

  IT WAS REPORTED ACCUCATH DID NOT SAFETY AFTER PRODUCT PLACEMENT IN PATIENT, IMMEDIATELY PLACED DEVICE IN SHARPS CONTAINER PER CUSTOMER. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24429130 ↗
• MalfunctionFeb 3, 2026Activation Problem

  IT WAS REPORTED BY MEDWATCH UPON ENDING THE PROCEDURE THERE WAS A FAILED ATTEMPT TO RETRACT THE WIRE. THE NEEDLE WOULD NOT ALSO NOT RETRACT ALTHOUGH COULD BE PUSHED MANUALLY BACK INTO HOUSING. THE WIRE WAS LOOPING OUT OF HOUSING WHEN NEEDLE WAS PUSHED BACK. NO INJURY OR NEGATIVE OUTCOME NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24251894 ↗
• MalfunctionJan 23, 2026Material Deformation

  IT WAS REPORTED BY THE CUSTOMER THAT THE CATHETER ON THE ACCUCATH DEVICE IS ¿CRUMBLING¿ WHEN IT IS BEING DEPLOYED OFF THE NEEDLE DURING PLACEMENT. THE CATHETER WAS NOT ABLE TO BE USED, REQUIRING STAFF TO USE ANOTHER DEVICE AND RESULTING IN THE PATIENT BEING STUCK AGAIN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24162777 ↗
• MalfunctionJan 20, 2026

  UPON ENDING THE PROCEDURE THERE WAS A FAILED ATTEMPT TO RETRACT THE WIRE. THE NEEDLE WOULD NOT ALSO NOT RETRACT ALTHOUGH COULD BE PUSHED MANUALLY BACK INTO HOUSING. THE WIRE WAS LOOPING OUT OF HOUSING WHEN NEEDLE WAS PUSHED BACK.

  Patient problems: Insufficient Information

  MAUDE report 24114610 ↗
• MalfunctionJan 16, 2026Product Quality Problem

  IT WAS REPORTED BY CUSTOMER THAT THE GUIDE WIRE IS NOT RETRACTING. NO ADDITIONAL INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24101224 ↗
• MalfunctionJan 5, 2026Activation Problem

  IT WAS REPORTED THAT THE GUIDEWIRE TAB WOULD NOT MOVE FORWARD (AS IF IT WAS STUCK ON SOMETHING) AND COULD NOT DEPLOY THE NEEDLE SAFETY BUTTON. NO IMPACT TO THE PATIENT OR USER. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23958408 ↗
• MalfunctionDec 19, 2025Material Frayed; Difficult to Insert; Material Frayed; Difficult to Insert

  IT WAS REPORTED ACCUCATH WAS INSERTED AND GUIDEWIRE WAS ADVANCED. CATHETER WAS THEN ADVANCED AND NEEDLE RETRACTED. THE GUIDEWIRE WOULD NOT RETRACT AND THERE WAS RESISTANCE. CATHETER WAS MANIPULATED SLIGHTLY AND A POPPING SOUND WAS HEARD AND THE ENTIRE DEVICE WAS REMOVED. PATIENT HAD TO RECEIVE AN ULTRASOUND, AN XRAY OF THE ARM AND A CTA TO RULE OUT FOREIGN BODY RETAINMENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 23851492 ↗
• MalfunctionDec 16, 2025Activation Problem; Activation Problem

  IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLE WON'T RETRACT. NO PATIENT HARM OCCURRED OTHER THAN A SECOND VENIPUNCTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23819202 ↗
• MalfunctionDec 16, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THE GUIDEWIRE IS SNAGGING. NO PATIENT HARM OCCURRED OTHER THAN A SECOND VENIPUNCTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23818806 ↗
• MalfunctionDec 16, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THE GUIDEWIRE IS SNAGGING. NO PATIENT HARM OCCURRED OTHER THAN A SECOND VENIPUNCTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23818805 ↗
• MalfunctionDec 16, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THE GUIDEWIRE IS SNAGGING. NO PATIENT HARM OCCURRED OTHER THAN A SECOND VENIPUNCTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23818648 ↗
• MalfunctionDec 16, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THE GUIDEWIRE IS SNAGGING. NO PATIENT HARM OCCURRED OTHER THAN A SECOND VENIPUNCTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23818632 ↗
• MalfunctionDec 16, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THE GUIDEWIRE IS SNAGGING. NO PATIENT HARM OCCURRED OTHER THAN A SECOND VENIPUNCTURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23818631 ↗
• MalfunctionDec 10, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THE ACCUCATH KIND OF FELL APART WHILE I WAS INSERTING IT IN A PATIENT. IT WOULD NOT THREAD DOWN, AND THE NEEDLE WOULD NOT RECESS. I JUST MANUALLY PUSHED THE CATHETER PART OVER THE NEEDLE INTO THE VEIN LIKE I WOULD AN IV. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23769024 ↗
• MalfunctionDec 4, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED VIA MEDSUN THAT DURING ACCUCATH INSERTION HAVING ISSUE WITH ADVANCING CATHETER OVER WIRE. UPON TRYING TO PRESS NEEDLE RETRACTOR IT WOULD NOT RETRACT. PULLING OUT OF PT WAS TIGHT COMING OUT OF SKIN. UPON TRYING TO GET NEEDLE TO RETRACT ONCE OUT OF PT IT WOULD NOT RETRACT FULLY, AND WIRE CIRCLED OUTSIDE OF HOUSING. IT IS UNKNOWN WHAT THERAPIES WERE BEING USED ON THE PATIENT AT THE TIME OF THE EVENT. THE PATIENT IS CRITICALLY ILL. NO FURTHER DETAILS AVAILABLE OR PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23717493 ↗
• MalfunctionDec 4, 2025Activation Problem; Activation Problem

  IT WAS REPORTED THAT THE NEEDLE FAILED TO RETRACT WHEN THE BUTTON WAS PRESSED. THERE WAS NO INJURY TO THE PATIENT OR CLINICIAN. NEEDLE WAS DISPOSED OF PER HOSPITAL POLICY. THE NEEDLE DID NOT RETRACT OR MOVE AT ALL WHEN BUTTON WAS PRESSED. BUTTON DID DEPRESS AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23717290 ↗