AccuCath AceRecalls & reported problems across all models

We found 10 models of AccuCath Ace by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 305 adverse event reports in the FDA's MAUDE database, received between Oct 16, 2019 and Sep 23, 2026 — classified as 25 injuries, 280 malfunctions.

The most frequently reported specific device problem is “Activation Problem” (139 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported AccuCath Ace problems

AccuCath Ace models

10 models, most reported first. Each model has its own page with its reports, recalls and device details.

• AccuCath Ace AC1202250

  Catheter, intravascular, therapeutic, short-term less than 30 days
  153 reports
• AccuCath Ace AC1202252

  Catheter, intravascular, therapeutic, short-term less than 30 days
  59 reports
• AccuCath Ace AC1182250

  Catheter, intravascular, therapeutic, short-term less than 30 days
  55 reports
• AccuCath Ace AC1221252

  Catheter, intravascular, therapeutic, short-term less than 30 days
  12 reports
• AccuCath Ace AC1182252

  Catheter, intravascular, therapeutic, short-term less than 30 days
  10 reports
• AccuCath Ace AC1221250

  Catheter, intravascular, therapeutic, short-term less than 30 days
  8 reports
• AccuCath Ace AC1181250

  Catheter, intravascular, therapeutic, short-term less than 30 days
  3 reports
• AccuCath Ace AC1201250

  Catheter, intravascular, therapeutic, short-term less than 30 days
  3 reports
• AccuCath Ace AC1201252

  Catheter, intravascular, therapeutic, short-term less than 30 days
  1 report
• AccuCath Ace PCK00010

  Catheter, intravascular, therapeutic, short-term less than 30 days
  1 report

Recent AccuCath Ace adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Activation Problem

  It was reported AccuCath needle would not retract upon safetying device. Patient had multiple sticks. No further information was provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50868132 ↗
• 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 ↗
• 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 ISSUE WHILE PLACING AN ULTRASOUND GUIDED LINE USING 20G ACCUCATH. ACCUCATH GUIDEWIRE ADVANCED, CATHETER SLID OVER ACCUCATH GUIDEWIRE WITHOUT ISSUE. THE NEEDLE BUTTON WOULD NOT COMPRESS TO INITIATE NEEDLE RETRACTION FOR THE NEEDLE SAFETY. ULTRASOUND LINE ALMOST BECAME DISLODGED. NEEDLE WAS THEN MANUALLY PULLED OUT AND PLACED IN SHARPS BIN. THERE WAS NO BEND OR FLEX IN THE NEEDLE DURING INSERTION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25162104 ↗
• 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 12, 2026Activation Problem

  IT WAS REPORTED PUSH BUTTON SAFETY NOT DEPRESSING AND THEREFORE NOT SAFTEYING THE DEVICE POST VEIN ACCESS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25155993 ↗
• 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 6, 2026

  AN IV TEAM MEMBER REPORTED THAT AFTER REMOVING THE PRODUCT FROM ITS PACKAGING, IT WAS FOUND TO BE BENT AND THE GUIDEWIRE/STYLET COULD NOT BE ADVANCED OR RETRACTED. THE MEMBER STATED THAT THIS ISSUE OCCURRED WITH ALL THREE PACKAGES THAT WERE OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25093438 ↗
• MalfunctionMay 5, 2026Activation Problem

  IT WAS REPORTED BY CUSTOMER THAT ACCUCATH ACE DEVICE FAILED TO RETRACT THE NEEDLE WHEN THE BUTTON WAS DEPRESSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25088902 ↗
• 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 ↗
• 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 ↗
• 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 ↗

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