Peripheral Catheter Insertion Kit AC0202250Recalls & reported problems

Summary

The FDA's MAUDE database contains 172 adverse event reports that list this exact device (DI 00801741110948), received between Jul 1, 2016 and May 12, 2022 — classified as 36 injuries, 136 malfunctions.

The most frequently reported specific device problem is “Retraction Problem” (24 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 172 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED "VALVE IN ACCUCATH WAS LOOSE AND DETACHED FROM THE HUB WHILE CATHETER WAS BEING THREADED." (B)(6) 2022 - THE NEEDLE WOULD NOT RETRACT WHEN THE SAFETY BUTTON WAS PRESSED ON THE RETURNED DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14382924 ↗
• MalfunctionFeb 17, 2022Activation Problem; Activation Problem

  IT WAS REPORTED "THE NEEDLE WOULD NOT SAFETY WHEN THE NURSE PUSHED THE BUTTON." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13549194 ↗
• MalfunctionDec 1, 2021Activation Problem; Activation Problem

  IT WAS REPORTED "ACCUCATH NEEDLE WOULD NOT RETRACT WHEN SAFETY ACTIVATED POST GUIDEWIRE DEPLOYMENT. NEEDLE MANUALLY REMOVED FROM CATHETER ONCE INSERTED INTO PATIENT, AND RETRACTED INTO SAFETY CASING USED GRAVITY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12910452 ↗
• InjuryNov 23, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED "GUIDEWIRE THREADED INTO PATIENTS SKIN AND HAD TO BE REMOVED BY PHYSICIAN."

  Patient problems: Foreign Body In Patient

  MAUDE report 12862473 ↗
• MalfunctionOct 14, 2021Activation Problem; Activation Problem

  IT WAS REPORTED "ACCUCATH FAILED TO RETRACT. CLINICIAN DISCARDED THE PRODUCT BECAUSE IT HAD BEEN USED ON A PATIENT. HE HAD NO WAY TO SECURE TO NEEDLE WITHOUT POTENTIALLY RISKING SOMEONE BEING STUCK."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12635607 ↗
• InjurySep 24, 2021Break; Break

  IT WAS REPORTED VIA MS&S "DIRECTOR OF PICC TEAM STATES THAT WHILE ONE OF HER NURSES WAS PLACING AN ACCUCATH PIV, SHE HAD DIFFICULTY ADVANCING THE GUIDEWIRE BUT WAS FINALLY ABLE TO ADVANCE IT, HOWEVER IV PLASTIC CANNULA BROKE OFF AND IS IN PATIENT'S ARM. SHE CAN SEE WHERE IT IS USING ULTRASOUND." RESPONSE: "ADVISED TO CONSULT MD/SURGEON FOR EVALUATION AND PLAN TO REMOVE THE CANNULA. DISCUSSED POSSIBLE SCENARIOS FOR REMOVAL. NURSE THEN STATED THAT THERE WAS A DOCTOR WITH THE NURSE DURING INSERTION AND HE IS GETTING A SURGICAL CONSULT NOW. SHE STATED THAT THE NURSE WAS ON HER WAY TO BRING HER THE PRODUCT AND PRODUCT INFORMATION AND SHE WOULD CALL ME BACK WITH THE INFORMATION AS SOON AS THE NURSE ARRIVED. DID NOT RECEIVE CALL BACK FROM NURSE WITH ANY INFORMATION." WAS THERE ANY PATIENT HARM REPORTED? YES THE PATIENT REQUIRED SURGERY TO REMOVE THE PIECE OF CATHETER.

  Patient problems: Foreign Body In Patient

  MAUDE report 12527109 ↗
• InjurySep 17, 2021Break; Break

  IT WAS REPORTED "NURSE STATES NO RESISTANCE ON ADVANCING THE GUIDEWIRE. CATHETER BROKE IN HALF WHILE PULLING THE NEEDLE OUT. ONE HALF LEFT IN PATIENT." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12490304 ↗
• InjuryJul 30, 2021Material Frayed; Material Frayed

  IT WAS REPORTED "COILED TIP OF THE WIRE BROKE OFF WHILE ATTEMPTING TO PLACE THE IV. WIRE REMAINED IN PATIENT. NURSE SAID INSERTION WAS NORMAL WITH NO RESISTANCE BUT WOULD NOT THREAD NOR SAFETY WHEN TRYING TO ADVANCE THE CATHETER AND ACTIVATE THE SAFETY." IT WAS REPORTED VIA MEDWATCH "WHILE INSERTING AN ULTRASOUND GUIDED IV INTO THE RIGHT ARM, THE TIP OF THE ACCUCATH GUIDEWIRE BROKE OFF INTO THE PATIENT, CONFIRMED BY X-RAY AND INSPECTION OF THE DEVICE."

  Patient problems: Foreign Body In Patient

  MAUDE report 12253718 ↗
• MalfunctionJun 30, 2021Defective Component; Defective Component

  IT WAS REPORTED THE GUIDEWIRE WOULD NOT RETRACT. NO OTHER INFORMATION WAS PROVIDED. 6/10/2021: THE RETURNED DEVICE WAS FOUND KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12093703 ↗
• MalfunctionJun 23, 2021Difficult to Remove; Difficult to Remove

  IT WAS REPORTED "DURING AN ATTEMPTED PLACEMENT OF AN US GUIDED IV LINE INTO THE MEDIAL RIGHT ANTECUBITUS WITH A 20G ACCUCATH INTRAVASCULAR CATHETER, REF (B)(4), LOT REEY2688 BY EM STAFF THERE WAS DIFFICULTY RETRACTING THE CATHETER AND IT BECAME STUCK IN THE PATIENT'S ARM. WITH GENTLE TRACTION THE CATHETER CAME OUT, BUT THE EM PHYSICIAN WAS NOT SURE IF ALL OF THE WIRE CAME OUT. AT THE END OF THE WIRE IS AN APPROXIMATELY 1MM DIAMETER METAL LOOP, AND IT WAS UNCLEAR TO THE ER PHYSICIAN IF THIS TINY PIECE OF WIRE WAS RETAINED IN THE PTS VEIN/SOFT TISSUES OF HIS ARM. IT WAS UNABLE TO BE VISUALIZED ON ULTRASOUND."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12050222 ↗
• MalfunctionJun 16, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED VIA PHONE CALL "CUSTOMER STATING THAT THE FACILITY RECEIVED ITEM THAT WAS DEFECTIVE. HE STATED THAT THE GUIDEWIRES WERE STICKING IN THE CANNULA WHEN REMOVING CANNULA FROM PATIENT. NO PATIENT IMPACT REPORTED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12011332 ↗
• MalfunctionJun 16, 2021Activation Problem; Activation Problem

  IT WAS REPORTED "PLACED AN ACCUCATH UNDER ULTRASOUND AND THE NEEDLE SAFETY BUTTON DID NOT RETRACT NEEDLE. NURSE SAID SHE HAD TO PULL WHOLE NEEDLE AND GUIDEWIRE OUT WITH A LITTLE BIT OF FORCE." ADD INFO RCVD (B)(6) 2021: PLACEMENT INFO: #20 ACCUCATH PLACED TO RIGHT CEPHALIC VEIN. I HAD NO ISSUE ACCESSING THE VEIN. GUIDEWIRE ADVANCED WITHOUT ISSUE. I HAD PRESSED THE BUTTON TO RETRACT THE NEEDLE AND IT WOULD NOT RETRACT. I RELEASED THE TOURNIQUET AND ATTEMPTED TO SLIGHTLY PULL BACK ON THE ACCUCATH AND WAS MEETING RESISTANCE. I STABILIZED THE CATHETER AND PULLED BACK AGAIN, WITH A LITTLE MORE FORCE, NOT WANTING TO PULL BACK TOO HARD AND DISLODGE THE CATHETER. THE NEEDLE THEN FINALLY RELEASED AND RETRACTED AND GUIDEWIRE WAS INTACT. THE DEVICE WAS HANDED OVER TO BD CLINICAL SPECIALIST, WHO WAS IN THE FACILITY TO TRAIN ANOTHER EMPLOYEE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12009704 ↗
• MalfunctionJun 3, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "PLASTIC CATHETER SHEARED DURING ADVANCEMENT. PLASTIC CATHETER WAS REMOVED WITH NO BREAK OCCURRING IN PATIENT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11930771 ↗
• MalfunctionJun 3, 2021Activation Problem; Activation Problem

  IT WAS REPORTED "NEEDLE RETRACTION SYSTEM DID NOT WORK AS INTENDED. SPRING WAS NOT ABLE TO FUNCTION PROPERLY AND RETRACT NEEDLE." IT WAS STATED THE DEVICE WAS CONTAMINATED WITH BLOOD AND WAS DISPOSED OF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11930601 ↗
• MalfunctionMay 21, 2021Material Deformation; Material Deformation

  IT WAS REPORTED ¿ CATHETER FOLDED IN HALF INSIDE VEIN ¿ PLACEMENT AND WIRE ADVANCED, NO BLOOD FLOW AFTER WIRE RETRACTED, WOULD NOT FLUSH, REMOVED AND CATHETER WAS KINKED AT ½¿ DEPTH¿. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11867024 ↗
• MalfunctionMay 21, 2021Activation Problem; Activation Problem

  IT WAS REPORTED " GUIDE WIRE WOULD NOT RETRACT, WHEN IT DID, IT SNAGGED INSIDE THE END OF THE CATHETER, BLOOD RUNNING OUT, NEEDLE NOT RETRACTING WITH BUTTON". NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11866416 ↗
• InjuryMay 21, 2021Material Frayed; Material Frayed

  IT WAS REPORTED VIA MEDWATCH, "THE 20G 2.25 ACCUCATH WAS PLACED IN THE ED AND THE GUIDEWIRE BROKE OFF IN THE PATIENT'S ARM. 4.5CM OF THE ACCUCATH WIRE WAS SUCCESSFULLY RETRIEVED FROM THE PATIENT'S TOP LAYER OF SKIN THAT SAME EVENING." ADDITIONAL INFO. RECEIVED 04/27/2021. WHAT THEY'RE BEING TREATED FOR: HEADACHE/NAUSEA/ABDOMINAL PAIN. EXPLANT DATE: (B)(6) 2021 REMOVED BY CARDIOTHORACIC SERVICE.

  Patient problems: Foreign Body In Patient

  MAUDE report 11864094 ↗
• MalfunctionApr 16, 2021Activation Problem; Activation Problem

  IT WAS REPORTED "FROM ED EDUCATOR: UNFORTUNATELY WE HAVE NOW HAVE TWO REPORTED PRODUCT FAILURES OF THE ACCUCATH INTRAVASCULAR CATHETER. BOTH FAILED TO RETRACT FULLY LEAVING THE NEEDLE TIP EXPOSED PUTTING BOTH THE PATIENT AND PROVIDER AT RISK. THEY ARE FROM THE SAME LOT." FROM ED MANAGER AFTER FIRST EMAIL: NOT ONLY ARE THEY FAILING TO RETRACT, THE GUIDEWIRE IS POKING THROUGH THE SIDE OF THE IV CATHETER AND BENDING WHEN IT IS INSIDE THE PATIENT.¿ IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11680482 ↗
• MalfunctionApr 16, 2021Activation Problem; Activation Problem

  IT WAS REPORTED "FROM ED EDUCATOR: UNFORTUNATELY WE HAVE NOW HAVE TWO REPORTED PRODUCT FAILURES OF THE ACCUCATH INTRAVASCULAR CATHETER . BOTH FAILED TO RETRACT FULLY LEAVING THE NEEDLE TIP EXPOSED PUTTING BOTH THE PATIENT AND PROVIDER AT RISK. THEY ARE FROM THE SAME LOT. " FROM ED MANAGER AFTER FIRST EMAIL : NOT ONLY ARE THEY FAILING TO RETRACT, THE GUIDEWIRE IS POKING THROUGH THE SIDE OF THE IV CATHETER AND BENDING WHEN IT IS INSIDE THE PATIENT.¿ IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11680391 ↗
• MalfunctionMar 26, 2021Activation Problem; Activation Problem

  IT WAS REPORTED ACCUCATH WOULD NOT SAFETY AFTER INSERTION AND BUTTON PUSHED. NEEDLE EXPOSED AFTER INSERTION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11577151 ↗
• MalfunctionMar 26, 2021Failure to Infuse; Failure to Infuse

  IT WAS REPORTED TWO INSERTIONS WERE SUCCESSFUL, BLOOD RETURN, ETC., WITH OUR PRIMARY IV TEAM AND WITHIN ABOUT 4 HOURS THE IV WON¿T FLUSH. WHEN REMOVING THE CATHETERS THERE ARE NOT ANY KINKS OR BENDS AND THE LUMENS WILL NOT FLUSH EVEN AFTER REMOVAL FROM THE PATIENT. ADDITIONAL INFORMATION PROVIDED 03/04/2021: IT WAS REPORTED THE CATHETERS PLACED QUIT WORKING WITHIN 6 HOURS OF PLACEMENT, WITH BLOOD RETURN AND FLUSH BEING ABLE TO BE COMPLETED UPON INSERTION. WHEN REMOVED THE CATHETER WAS NOT KINKED OR BENT IN ANYWAY AND WOULD NOT FLUSH AT ALL AFTER REMOVAL EVEN WITH NO EVIDENCE OF OCCLUSION IN CATHETER TIP. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11576716 ↗
• MalfunctionMar 26, 2021Failure to Infuse; Failure to Infuse

  IT WAS REPORTED INSERTION WAS SUCCESSFUL, BLOOD RETURN, ETC., WITH OUR PRIMARY IV TEAM AND WITHIN ABOUT 4 HOURS THE IV WON¿T FLUSH. WHEN REMOVING THE CATHETER THERE ARE NOT ANY KINKS OR BENDS AND THE LUMEN WILL NOT FLUSH EVEN AFTER REMOVAL FROM THE PATIENT. ADDITIONAL INFORMATION PROVIDED 03/04/2021: IT WAS REPORTED THE CATHETER PLACED QUIT WORKING WITHIN 6 HOURS OF PLACEMENT, WITH BLOOD RETURN AND FLUSH BEING ABLE TO BE COMPLETED UPON INSERTION. WHEN REMOVED THE CATHETER WAS NOT KINKED OR BENT IN ANYWAY AND WOULD NOT FLUSH AT ALL AFTER REMOVAL EVEN WITH NO EVIDENCE OF OCCLUSION IN CATHETER TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11576705 ↗
• MalfunctionMar 26, 2021Failure to Infuse; Failure to Infuse

  IT WAS REPORTED TWO INSERTIONS WERE SUCCESSFUL, BLOOD RETURN, ETC., WITH OUR PRIMARY IV TEAM AND WITHIN ABOUT 4 HOURS THE IV WON¿T FLUSH. WHEN REMOVING THE CATHETERS THERE ARE NOT ANY KINKS OR BENDS AND THE LUMENS WILL NOT FLUSH EVEN AFTER REMOVAL FROM THE PATIENT. ADDITIONAL INFORMATION PROVIDED 03/04/2021: IT WAS REPORTED THE CATHETERS PLACED QUIT WORKING WITHIN 6 HOURS OF PLACEMENT, WITH BLOOD RETURN AND FLUSH BEING ABLE TO BE COMPLETED UPON INSERTION. WHEN REMOVED THE CATHETER WAS NOT KINKED OR BENT IN ANYWAY AND WOULD NOT FLUSH AT ALL AFTER REMOVAL EVEN WITH NO EVIDENCE OF OCCLUSION IN CATHETER TIP. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11576704 ↗
• InjuryMar 7, 2021Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  IT WAS REPORTED ¿THE ACCUCATH IV CATH-TIP CAME OFF UPON REMOVAL. WHILE ATTEMPTING IV ACCESS ON A PT YESTERDAY WITH A 2.25CM ANGIO CATH, VISUALIZATION WAS MADE INSIDE THE VESSEL, THE GUIDE WIRE WAS INSERTED WITH NO COMPLICATIONS, AND I ATTEMPTED TO THREAD THE CATHETER AND WAS THEN MET WITH CONSIDERABLE RESISTANCE HALF WAY THROUGH INSERTION. I STOPPED PROGRESS AND RETRACTED THE GUIDE WIRE AND NEEDLE, HEARD AND FELT THE AUDIBLE CLICK. I THEN ATTEMPTED TO REMOVE THE CATHETER AND AGAIN WAS MET WITH CONSIDERABLE RESISTANCE. WITH SLOW AND GENTLE PRESSURE, I STARTED TO REMOVE THE CATHETER AND IT GAVE WAY AND I NOTICED THE END HAD A TEAR ON IT. AFTER COMPARING THE CATHETER TO A NEW ONE, I COULD SEE THAT A PORTION WAS MISSING. I WAS ABLE TO PLACE THE PROBE BACK ON THE INSERTION SITE AND I COULD VISUALIZE A PIECE OF THE CATHETER. I INFORMED THE PHYSICIAN IMMEDIATELY AND SHOWED HER THE CATHETER. SHE THEN CALLED IR TO PLACE A PIC LINE AND TO REMOVE THE REMAINING CATHETER. A LITTLE WHILE LATER SHE INFORMED ME THAT THE CATHETER HAD BROKEN IN SOFT TISSUE AND NOT THE VESSEL, AND THAT A PORTION OF THE WIRE WAS ALSO FOUND. AFTER RETRACTING THE WIRE AND NEEDLE, I HAD PLACED IT IN THE SHARPS CONTAINER

  Patient problems: Foreign Body In Patient

  MAUDE report 11426774 ↗
• MalfunctionFeb 26, 2021Failure to Infuse; Difficult to Flush; Failure to Infuse

  IT WAS REPORTED " WE USED 4 OUT THIS BOX WITH SUCCESSFUL INSERTION, BLOOD RETURN, ETC., WITH OUR PRIMARY IV TEAM AND WITHIN ABOUT 4 HOURS THE IV WON¿T FLUSH. WHEN REMOVING THE CATHETER THERE ARE NOT ANY KINKS OR BENDS AND THE LUMEN WILL NOT FLUSH EVEN AFTER REMOVAL FROM THE PATIENT." THIS REPORT ADDRESSES THE FIRST OF THE FOUR DEVICES. ADDITIONAL INFORMATION PROVIDED 03/04/2021: "ALL OF THE GUIDELINE CATHETERS PLACED QUIT WORKING WITHIN 6 HOURS OF PLACEMENT, WITH BLOOD RETURN AND FLUSH BEING ABLE TO BE COMPLETED UPON INSERTION. WHEN REMOVED THE CATHETER WAS NOT KINKED OR BENT IN ANYWAY AND WOULD NOT FLUSH AT ALL AFTER REMOVAL EVEN WITH NO EVIDENCE OF OCCLUSION IN CATHETER TIP."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11385721 ↗