AccuCath Ace AC1221250Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00801741137938), received between Jul 31, 2020 and May 12, 2026 — classified as 2 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• MalfunctionDec 31, 2025Material Frayed; Material Frayed

  IT WAS REPORTED VIA MEDWATCH THAT ATTEMPTED TO PLACE 22G ACCUCATH IN PATIENT'S LEFT FOREARM. RN TRIED TO RETRACT GUIDEWIRE. GUIDEWIRE UNABLE TO BE FULLY RETRACTED. RESISTANCE MET WHEN TRYING TO FULLY REMOVE DEVICE FROM PATIENT'S SKIN. MD CONTACTED VASCULAR SURGERY PHYSICIAN REMOVED DEVICE FROM PATIENT'S ARM APPROXIMATELY 1-2MM OF GUIDEWIRE TIP NOT PRESENT UPON INSPECTION OF DEVICE. X-RAY ORDERED AND NO METAL NOTED IN X-RAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23934222 ↗
• MalfunctionNov 13, 2024Defective Component; Detachment of Device or Device Component; Defective Component; Detachment of Device or Device Component

  IT WAS REPORTED BY CUSTOMER THAT WHEN SHE WENT TO DEPLOY THE CATHETER THE CATHETER 'TIP OF THE HOUSING' ALSO DEPLOYED. DATE WAS (B)(6)2024. I DON'T KNOW IF PATIENT HARM EVER OCCURRED LATER. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20678833 ↗
• MalfunctionOct 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED BY CUSTOMER THAT "WHEN SHE WENT TO DEPLOY THE CATHETER THIS PART ALSO DEPLOYED.¿ THE NURSE PLACING THE DEVICE STATED THAT WHEN SHE WENT TO RETRACT THE NEEDLE/WIRE IT FELT LIKE SOMETHING GOT HUNG UP, AND WHEN LOOKING AT THE DEVICE AFTER REMOVAL NOTED THE PLASTIC PIECE THAT THEY HAD NEVER NOTICED BEFORE. IT WAS NOTED AFTER USE/PLACEMENT. NO IMPACT AS THE PATIENT DID NOT NEED TO BE RESTACK FOR IV ACCESS. NO ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20570643 ↗
• InjuryFeb 12, 2024Break; Break

  IT WAS REPORTED BY CUSTOMER THAT WHEN ATTEMPTING TO RETRACT GUIDEWIRE RESISTANCE WAS FELT. RN SUSPECTED GUIDEWIRE WAS RUBBING AGAINST THE INSIDE OF THE CATHETER ATTEMPTED TO WITHDRAW CATHETER WITH GUIDEWIRE. THERE WAS A DIFFERENCE IN LENGTH WHEN COMPARING THE USED CATHETER TO A NEW UNUSED ONE. ULTIMATELY, THE TIP/COIL AT THE TOP WAS NOT ATTACHED TO THE USED CATHETER WHICH RESULTED IN PATIENT BEING SENT TO THE OR TO HAVE IT SURGICALLY REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18688944 ↗
• MalfunctionMar 8, 2023Activation Problem; Activation Problem

  IT WAS REPORTED BY THE CUSTOMER THAT THE NURSE HIT THE SAFETY AND THE NEEDLE WOULD NOT RETRACT AFTER USE. THERE WAS NO HARM REPORTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16503733 ↗
• InjuryDec 15, 2022Material Frayed; Detachment of Device or Device Component; Material Frayed; Detachment of Device or Device Component

  IT WAS REPORTED BY THE CUSTOMER THAT "ACCUCATH - RETAINED GUIDEWIRE IN PATIENT. SURGERY WAS NEEDED FOR REMOVAL." 12/5/22 ADDITIONAL INFORMATION PROVIDED: VASCULAR ACCESS TEAM ATTEMPTED TO PLACE AN EXTENDED DWELL INTRAVENOUS LINE ON THE LEFT UPPER EXTREMITY (ACCUCATH ACE INTRAVASCULAR CATHETER 22G 1.25 INCH) ON (B)(6) 2022. THE GUIDEWIRE MALFUNCTIONED AND WAS PARTIALLY RETAINED. THE INTRAVENOUS CATHETER AND GUIDEWIRE WERE NOT ABLE TO BE REMOVED FROM THE PATIENT'S EXTREMITY. THE BREAK WAS NOTICED DURING INSERTION AND CONFIRMED WITH X-RAY OF LEFT ARM AND ULTRASOUND. SURGICAL TEAM NOTIFIED AFTER REMOVAL. SURGERY REQUIRED TO REMOVE BROKEN PIECE ON (B)(6) 2022, OPERATIVE NOTE INDICATES A SUCCESSFUL REMOVAL OF THE RETAINED FOREIGN BODY. SURGERY WAS UNCOMPLICATED AND NO LONG-TERM PATIENT EFFECTS. PATIENT IS BEING TREATED FOR RSV.

  Patient problems: Foreign Body In Patient

  MAUDE report 15988365 ↗
• MalfunctionJul 31, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE COILED TIP OF THE GUIDEWIRE OF THE ACCUCATH HAD COME UNDONE AT THE HUB OF THE CATHETER. UPON CLOSER INSPECTION THE GUIDEWIRE COIL HAD HOOKED INTO THE PATIENTS SKIN. RN WAS ABLE TO ASPIRATE AND FLUSH WITHOUT DIFFICULTY PRIOR TO NOTICING THE COILED TIP. RN ALSO SAID THE CATHETER UPON REMOVAL SHOWED KINKS IN SEVERAL LOCATIONS. THE LINE HAD TO BE TAKEN OUT AND THE PATIENT RECEIVED A SECOND STICK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10353309 ↗