AccuCath Ace AC1182250Recalls & reported problems

Summary

The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 00801741137945), received between Oct 16, 2019 and Sep 23, 2026 — classified as 1 injury, 54 malfunctions.

The most frequently reported specific device problem is “Activation Problem” (28 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 55 reports, 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 ↗
• 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 ↗
• MalfunctionMar 19, 2026Activation Problem

  IT WAS REPORTED BY A CUSTOMER THAT THE BUTTON DEPRESSED, SHARP DID NOT RETRACT. BUTTON REMAINED STUCK IN THE DEPRESSED POSITION. ALSO, THE GUIDE WIRE CAME OUT THE SIDE OF THE NEEDLE. NO FURTHER DETAILS PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 3/12/2026: ONE NEEDLE USED TO PERFORM AN ULTRASOUND-GUIDED PIV INSERTION. THE NEEDLE, GUIDE WIRE, AND CATHETER WORKED FINE FOR THE ACTUAL PLACEMENT OF THE IV, SO THE PATIENT SHOULD NOT HAVE BEEN AFFECTED BY THE DEVICE FLAW. THE PROBLEM DID NOT APPEAR UNTIL I ATTEMPTED TO RETRACT THE NEEDLE. I DID HAVE TO RECAP IT INSTEAD OF RETRACTING IN ORDER TO SAFELY SET IT DOWN WHILE I DRESSED THE IV. IT WAS REPORTED THIS OCCURRED WITH 4 DEVICES. THIS REPORT ADDRESSES ALL FOUR DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24641114 ↗
• MalfunctionMar 19, 2026Activation Problem

  IT WAS REPORTED THAT WHILE ATTEMPTING TO PLACE ULTRASOUND GUIDED IV IN A PATIENT, THE GUIDEWIRE WOULD NOT ADVANCE WHEN I WAS IN THE PATIENT¿S VEIN. I REMOVED THE IV AND PRESSED THE BUTTON TO RETRACT THE NEEDLE, HOWEVER THE NEEDLE DID NOT RETRACT FULLY. NO INJURY OCCURRED TO THE PATIENT AS SOON AS I REALIZED THAT THE GUIDE WIRE WAS STUCK AND NOT ADVANCE, I REMOVED THE IV COMPLETELY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24641111 ↗
• MalfunctionMar 18, 2026Activation Problem

  IT WAS REPORTED THAT WHILE ATTEMPTING TO PLACE ULTRASOUND GUIDED IV IN A PATIENT, THE GUIDEWIRE WOULD NOT ADVANCE WHEN I WAS IN THE PATIENT¿S VEIN. I REMOVED THE IV AND PRESSED THE BUTTON TO RETRACT THE NEEDLE, HOWEVER THE NEEDLE DID NOT RETRACT FULLY. NO INJURY OCCURRED TO THE PATIENT AS SOON AS I REALIZED THAT THE GUIDE WIRE WAS STUCK AND NOT ADVANCE, I REMOVED THE IV COMPLETELY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24634093 ↗
• MalfunctionMar 18, 2026Activation Problem

  IT WAS REPORTED THAT WHILE ATTEMPTING TO PLACE ULTRASOUND GUIDED IV IN A PATIENT, THE GUIDEWIRE WOULD NOT ADVANCE WHEN I WAS IN THE PATIENT¿S VEIN. I REMOVED THE IV AND PRESSED THE BUTTON TO RETRACT THE NEEDLE, HOWEVER THE NEEDLE DID NOT RETRACT FULLY. NO INJURY OCCURRED TO THE PATIENT AS SOON AS I REALIZED THAT THE GUIDE WIRE WAS STUCK AND NOT ADVANCE, I REMOVED THE IV COMPLETELY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24634092 ↗
• MalfunctionMar 12, 2026Activation Problem

  IT WAS REPORTED THAT THE NEEDLE FAILED TO RETRACT FOLLOWING INSERTION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24582701 ↗
• MalfunctionMar 4, 2026Activation Problem

  IT WAS REPORTED THE NEEDLE WOULD NOT RETRACT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24505644 ↗
• MalfunctionDec 18, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED ACCUCATH 18G 2.25¿ SELF-OCCLUDING FEATURE NOT WORKING AT ALL DIRECTLY AFTER SALTING THE NEEDLE. NO OTHER 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 23837954 ↗
• MalfunctionDec 18, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED ACCUCATH 18G 2.25¿ SELF-OCCLUDING FEATURE NOT WORKING AT ALL DIRECTLY AFTER SALTING THE NEEDLE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23837951 ↗
• MalfunctionDec 16, 2025Activation Problem; Activation Problem

  IT WAS REPORTED SNAGGING GUIDEWIRE # NEEDLE WOULDN'T RETRACT(18G). NO PATIENT HARM. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23817295 ↗
• MalfunctionDec 16, 2025Material Frayed; Activation Problem; Material Frayed; Activation Problem

  IT WAS REPORTED SNAGGING GUIDEWIRE NEEDLE WON'T RETRACT. NO PATIENT HARM. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23817291 ↗
• MalfunctionDec 16, 2025Product Quality Problem; Activation Problem; Product Quality Problem; Activation Problem

  IT WAS REPORTED SNAGGING GUIDEWIRE # NEEDLE WOULDN'T RETRACT (18G). NO PATIENT HARM. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23817289 ↗
• MalfunctionDec 16, 2025Activation Problem; Activation Problem

  IT WAS REPORTED GUIDEWIRE SNAGGING - SHARP WOULD NOT RETRACT (18G AACCU CATH). NO PATIENT HARM. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23817285 ↗
• MalfunctionDec 16, 2025Material Frayed; Activation Problem; Material Frayed; Activation Problem

  IT WAS REPORTED SNAGGING GUIDEWIRE - SAFETY JAMMED(18G ACCUCATH). NO PATIENT HARM. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23816936 ↗
• MalfunctionDec 16, 2025Product Quality Problem; Activation Problem; Product Quality Problem; Activation Problem

  IT WAS REPORTED SNAGGING GUIDEWIRE D NEEDLE WON'T RETRACT (18G ACCULASN). NO PATIENT HARM. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23816930 ↗
• MalfunctionDec 9, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT GUIDEWIRE GETTING STUCK IN DISTAL OPENING AND TEARING THE CATHETER, SAFETY NOT ACTIVATING. NO FURTHER DETAILS AVAILABLE OR PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23759211 ↗
• MalfunctionDec 9, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT GUIDEWIRE GETTING STUCK IN DISTAL OPENING AND TEARING THE CATHETER, SAFETY NOT ACTIVATING. NO FURTHER DETAILS AVAILABLE OR PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23759205 ↗
• MalfunctionDec 9, 2025Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT GUIDEWIRE GETTING STUCK IN DISTAL OPENING SEVERAL TIMES AND TEARING THE CATHETER, SAFETY NOT ACTIVATING. NO FURTHER DETAILS AVAILABLE OR PROVIDED. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES BOTH DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23759204 ↗
• MalfunctionOct 15, 2025Activation Problem; Activation Problem

  ADDITIONAL INFORMATION PROVIDED 14-OCT-2025: NO ADVERSE EVENT/INJURY. REQUIRED 2ND POKE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23302625 ↗
• MalfunctionAug 6, 2025Activation Problem; Activation Problem

  IT WAS REPORTED, "WE'VE BEEN HAVING PROBLEMS WITH ACCUCATHS RETRACTION OF THE NEEDLE. DEVICE DOES NOT SAFETY WHEN BUTTON IS PRESSED." THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22732011 ↗
• MalfunctionJul 14, 2025Activation Problem; Activation Problem

  IT WAS REPORTED VIA MEDSUN: HAD 2 DEVICES WHERE THE CATHETER WAS SUCCESSFULLY PLACED BUT THE AUTO RETRACT ON THAT WOULD NOT RETREAT ON ITS OWN AND THE NEEDLE AND HAD TO BE WITHDRAWN WITH THE NEEDLE STILL EXPOSED. THIS REPORT ADDRESSES BOTH DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22501630 ↗
• MalfunctionJun 30, 2025Retraction Problem; Self-Activation or Keying; Stretched; Failure to Advance

  ACCUCATH ACE 18G, WE'VE HAD MULTIPLE ISSUES WITH MULTIPLE PATIENTS. WE HAD ONE CATHETER THAT AUTO REACTED DURING PROCEDURE WITHOUT THE AUTO RETRACTOR BUTTON BEING HIT. ANOTHER WAS THE GUIDEWIRE HAD STRAIGHTENED OUT WITHIN THE CATHETER AND WAS CATCHING AND COULD NOT BE ADVANCED. ANOTHER TWO WERE THE CATHETER WAS SUCCESSFULLY PLACED BUT THE AUTO RETRACT ON THAT WOULD NOT RETREAT ON IT'S OWN AND THE NEEDLE AND HAD TO BE WITHDRAWN WITH THE NEEDLE STILL EXPOSED. THESE ARE ALL FROM THE SAME LOT, WE HAVE SINCE PULLED THE REMAINDER OF THE STOCK FROM THE LOT FROM OUR DEPARTMENT. LOT NUMBER REKP0794 IT'S THE ACCUCATH ACE 2 1/4 INCH CATHETERS. MULTIPLE PATIENTS YESTERDAY AND TODAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22352602 ↗
• MalfunctionMar 13, 2025Difficult to Insert; Defective Component; Difficult to Insert; Defective Component

  IT WAS REPORTED BY CUSTOMER THAT WHILE PLACING THE ACCUCATH AND THE PATIENT WAS COMPLAINING OF PAIN SO SHE REMOVED THE ACCUCATH AND THERE WAS A HOLE IN THE NEEDLE.

  Patient problems: Pain

  MAUDE report 21601021 ↗
• MalfunctionFeb 25, 2025Defective Component; Defective Component

  IT WAS REPORTED DIFFICULTY DEPLOYING THE ACCUCATH GUIDEWIRE WHILE IN PROCEDURE. DIFFICULTY THREADING CATHETER INTO THE VESSEL WHEN ACCESS WAS DETERMINED. DEVICE REMOVED ENTIRELY TO FIND THE ACCUCATH WIRE EXITING OUT THE SIDE OF THE NEEDLE. PATIENT REQUIRED 2ND STICK NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21465636 ↗