Peripheral Catheter Insertion Kit F322088PTRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00801741140693), received between Jun 28, 2019 and Apr 4, 2025 — classified as 10 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryApr 4, 2025Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT PLACEMENT OF 22G 8 CM POWERGLIDE CATHETER TO PATIENT¿S LEFT UPPER BASILIC VEIN WAS ATTEMPTED. CATHETER TO VEIN RATIO (CVR) CALCULATION COMPLETED PRIOR TO INSERTION AND DETERMINED TO BE 18%. VEIN DEPTH APPROXIMATELY 1 CM. PATIENT¿S VEIN WAS EASILY LOCATED AND ACCESSED WITH POWERGLIDE NEEDLE AND FOLLOWED THROUGH TO NEAR HUB OF DEVICE. DEPLOYED POWERGLIDE GUIDEWIRE WITH EASE AND WITHOUT RESISTANCE. ATTEMPTED TO THREAD CATHETER AND MET RESISTANCE ONCE ROUGHLY 3 CM OF CATHETER WAS INSIDE. AT THIS TIME I GRABBED THE ULTRASOUND PROBE TO IDENTIFY THE TIP LOCATION AND NOTED TIP TERMINATION STILL IN VEIN LUMEN. WHILE STILL VISUALIZING TIP UNDER ULTRASOUND, I ADJUSTED THE ANGLE OF THE DEVICE TO BE COMPLETELY CENTER OF VEIN LUMEN. THERE WAS NO MANIPULATION OF THE DEVICE GUIDEWIRE OR CATHETER WINGS. ONCE ANGLE WAS RE-ADJUSTED, ANOTHER ATTEMPT TO THREAD CATHETER WAS MADE AND WAS STILL MET WITH RESISTANCE. AT THIS TIME, REMOVAL OF THE DEVICE AS ONE UNIT, WITHOUT MANIPULATION OF CATHETER WINGS OR GUIDEWIRE WAS MADE AND MET WITH RESISTANCE UPON REMOVAL ATTEMPT. ASSESSED DEVICE LOCATION UNDER ULTRASOUND AND DEVICE NOTED TO BE JUST OUTSIDE THE TOP OF VEIN LUMEN IN

  Patient problems: Foreign Body In Patient

  MAUDE report 21774844 ↗
• MalfunctionJan 15, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED BY MEDWATCH THAT ATTEMPTED TO PLACE A 22G X 8CM POWERGLIDE IV CATHETER INTO THE RIGHT BASILIC VEIN AT THE AC USING ULTRASOUND GUIDANCE. THE NEEDLE TIP WAS VISUALIZED IN THE VEIN, THE WIRE WAS ADVANCED AND ALSO VISUALIZED IN THE VEIN. WAS UNABLE TO THREAD THE CATHETER SO ATTEMPTED TO REMOVE THE NEEDLE, WIRE AND CATHETER AS ONE DEVICE BUT MET RESISTANCE AND WAS UNABLE TO REMOVE THE DEVICE. IR ARRIVED TO BEDSIDE AND NUMBED THE INSERTION SITE WITH LIDOCAINE AND WAS ABLE TO REMOVE THE CATHETER FROM THE SKIN. WIRE WAS INTACT, CATHETER HAD SEPARATED NEAR THE HUB (OUTSIDE OF THE SKIN) BUT THE TIP WAS INTACT. CATHETER APPEARS TO HAVE BUNCHED UP UNDER THE SKIN CAUSING THE RESISTANCE TO REMOVE. NO FURTHER ISSUE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21162210 ↗
• MalfunctionJan 15, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED BY MEDWATCH THAT ATTEMPTED TO PLACE A 22G X 8CM POWERGLIDE IV CATHETER INTO THE RIGHT BASILIC VEIN AT THE AC USING ULTRASOUND GUIDANCE. THE NEEDLE TIP WAS VISUALIZED IN THE VEIN, THE WIRE WAS ADVANCED AND ALSO VISUALIZED IN THE VEIN. WAS UNABLE TO THREAD THE CATHETER SO ATTEMPTED TO REMOVE THE NEEDLE, WIRE AND CATHETER AS ONE DEVICE BUT MET RESISTANCE AND WAS UNABLE TO REMOVE THE DEVICE. IR ARRIVED TO BEDSIDE AND NUMBED THE INSERTION SITE WITH LIDOCAINE AND WAS ABLE TO REMOVE THE CATHETER FROM THE SKIN. WIRE WAS INTACT, CATHETER HAD SEPARATED NEAR THE HUB (OUTSIDE OF THE SKIN) BUT THE TIP WAS INTACT. CATHETER APPEARS TO HAVE BUNCHED UP UNDER THE SKIN CAUSING THE RESISTANCE TO REMOVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21161967 ↗
• InjuryJan 15, 2025Break; Defective Component; Break; Defective Component

  IT WAS REPORTED BY CUSTOMER THAT DURING PLACEMENT OF CATHETER IN THE LEFT CEPHALIC VESSEL A POSITIVE BLOOD RETURN WAS NOTED. THE VESSEL SIZE WAS AT 0.32 CM, ALMOST 1 CM DEEP THE VESSEL WAS ACCESSED AND THE WIRE SLID WITHOUT COMPLICATION, WHEN INSERTING THE CATHETER IT WAS ¿STICKY¿, AND THE PATIENT COMPLAINED OF PAIN. A BULGE STARTED FORMING JUST PROXIMAL TO THE INSERTION SITE, CLOSE TO THE 4CM PROXIMAL. CATHETER PLACEMENT WAS ABORTED, THE WIRE WAS UNABLE TO WITHDRAW. THE PATIENT IS NOW COMPLAINING OF A LOT OF PAIN AND THE CATHETER HAD DISCONNECTED FROM THE HUB SO ALL THAT WAS EXPOSED FROM THE SKIN WAS THE ACCESS NEEDLE. THE CATHETER COULD NOT BE SEEN. THE ARM AND CATHETER WAS WRAPPED IN KERLEX FOR PATIENT COMFORT UNTIL THE LINE COULD BE REMOVED. XRAY AND CT COMPLETED. IR REMOVED THE STUCK GUIDEWIRE BUT WITH THE CATHETER NOT BEING ATTACHED TO THE HUB IT DIDN'T COME OUT WITH THE WIRE. THE FOLLOWING DAY IR REMOVED THE ENTIRE DEVICE WHICH MEASURED JUST UNDER 7.8CM LONG. THIS WAS AN INDICATION THAT THE ENTIRE CATHETER WAS RETRIEVED AS ½ CM WAS STILL ATTACHED TO THE HUB AND THIS WAS AN 8CM CATHETER. NO OTHER INFORMATION PROVIDED, AT THIS TIME.

  Patient problems: Pain

  MAUDE report 21160261 ↗
• MalfunctionJan 14, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED VIA MEDWATCH, ATTEMPTED TO PLACE A 22G X 8CM POWERGLIDE IV CATHETER INTO THE RIGHT BASILIC VEIN AT THE AC USING ULTRASOUND GUIDANCE. THE NEEDLE TIP WAS VISUALIZED IN THE VEIN, THE WIRE WAS ADVANCED AND ALSO VISUALIZED IN THE VEIN. WAS UNABLE TO THREAD THE CATHETER SO ATTEMPTED TO REMOVE THE NEEDLE, WIRE AND CATHETER AS ONE DEVICE BUT MET RESISTANCE AND WAS UNABLE TO REMOVE THE DEVICE. IR ARRIVED TO BEDSIDE AND NUMBED THE INSERTION SITE WITH LIDOCAINE AND WAS ABLE TO REMOVE THE CATHETER FROM THE SKIN WITH NO ADDITIONAL ISSUES. WIRE WAS INTACT, CATHETER HAD SEPARATED NEAR THE HUB (OUTSIDE OF THE SKIN) BUT THE TIP WAS INTACT. CATHETER APPEARS TO HAVE BUNCHED UP UNDER THE SKIN CAUSING THE RESISTANCE TO REMOVE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21154088 ↗
• InjuryNov 14, 2024Material Frayed; Difficult to Remove; Material Frayed; Difficult to Remove

  MATERIAL # F322088PT BATCH # REJS3882. IT WAS REPORTED THE CLINICIAN ATTEMPTED PLACEMENT FOR A NORMAL PROCEDURE, VISUALIZED BOTH NEEDLE AND CATHETER TIP IN VESSEL LUMEN, GUIDE WIRE ADVANCED SMOOTHLY BUT CATHETER AND WINDS HAD DIFFICULTY ADVANCING. COULD NOT RETRACT CATHETER BACK, CATHETER BECAME STUCK IN SKIN, SCALPEL NEEDED TO KNICK SKIN TO REMOVE CATHETER. NO PATIENT DAMAGE REPORTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20683624 ↗
• InjuryFeb 23, 2024Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  IT WAS REPORTED, "PLACED A MIDLINE CATHETER ON A PATIENT IN THE OR. USED THE POWERGLIDE AS IS, HOWEVER, THE CATHETER BROKE AND A SURGEON HAD TO COME AND DO A CUT DOWN TO GET THE RETAINED WIRE/MIDLINE CATHETER. TO THEIR BEST UNDERSTANDING, THE CATHETER BROKE OFF, BUT THE SURGEON WAS ABLE TO REMOVE SUCCESSFULLY." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18773620 ↗
• InjuryAug 16, 2023Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component

  IT WAS REPORTED GUIDEWIRE IN MIDLINE WAS STUCK IN PATIENT. PATIENT HAD TO HAVE SURGERY TO REMOVE. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17558352 ↗
• InjuryJan 13, 2023Break; Fluid/Blood Leak; Improper or Incorrect Procedure or Method; Break; Fluid/Blood Leak; Improper or Incorrect Procedure or Method

  IT WAS REPORTED BY THE CUSTOMER, "WE HAD A POWERGLIDE CATHETER DISLODGE INTO A PATIENT TODAY. CLINICIAN WAS PLACING, GUIDEWIRE THREADED NO PROBLEM BUT THEN THE CATHETER DIDN'T THREAD. TRIED TO PULL EVERYTHING BACK AND PART OF THE CATHETER WASN'T INTACT. WE ARE WORKING WITH IR AND RADIOLOGY". ADDITIONAL INFORMATION RECEIVED 12/28/2022. A DETAILED DESCRIPTION OF THE EVENT: ASSESSED FOR DIVA, RIGHT FA BELOW AC BEST VEIN OPTION MEASURING 1.9MM WITHOUT TORNIQUET. VEIN FOLLOWED UP THE ARM, EASILY COMPRESSIBLE, DOES MAKE A CURVE BUT ADEQUATE FOR 22GX8CM POWERGLIDE CATHETER PLACEMENT. VEIN ACCESSED WITH NO COMPLICATIONS, GUIDEWIRE EASILY DEPLOYED, CATHETER ADVANCED ABOUT ½ WAY WHEN RESISTANCE FELT. ATTEMPTED TO PULL CATHETER BACK WITHOUT SUCCESS. HAD TO PULL DEVICE (CATHETER, NEEDLE, GUIDEWIRE) OUT ALL TOGETHER AT THE SAME TIME. ONCE OUT NOTICED 4 CM OF CATHETER WAS NOT INTACT. X-RAY OBTAINED OF CHEST AND ARM. CATHETER FOUND LOOPED JUST BELOW THE AC. IR CONSULTED FOR REMOVAL. UNABLE TO VISUALIZE CATHETER WITH FLURO, ATTEMPTED REMOVAL WITHOUT SUCCESS DUE TO SMALL AND UNABLE TO VISUALIZE. IR STATES THAT THE VEIN THE CATHETER IS RETAINED IS BIND ENDING WITH VALVULAR STENOSIS AND THAT THE VEIN

  Patient problems: Foreign Body In Patient

  MAUDE report 16157976 ↗
• InjuryNov 1, 2022Break; Break

  IT WAS REPORTED BY THE CUSTOMER "THE CATHETER BROKE OFF THE HUB AT THE PATIENT'S INSERTION SITE. "AT APPROXIMATELY 1200, THIS RN, ATTEMPTED A MIDLINE INSERTION ON THE LEFT UPPER BASILIC VESSEL IN A STERILE FASHION. AFTER DEPLOYING THE GUIDEWIRE, THE CATHETER WAS THREADED INTO THE VEIN. WHEN TRYING TO REMOVE THE GUIDEWIRE DEVICE, THE CATHETER AND NEEDLE WOULD NOT RELEASE OUT OF THE VESSEL. THE CATHETER SHEARED OFF AT THE LEVEL OF THE SKIN. SURGERY WAS CALLED TO THE BEDSIDE FOR EVALUATION." DID THE EVENT RESULT IN ANY LONG-TERM HARM (IF YES, PLEASE DESCRIBE), OR DID IT RESULT IN A DELAY IN TREATMENT THAT HAD A NEGATIVE IMPACT ON PATIENT OUTCOMES? DELAY IN TREATMENT AND NEGATIVE IMPACT ON PATIENT. IT WAS PAINFUL TO REMOVE. WAS A NEW DEVICE SUCCESSFULLY INSERTED FOR VASCULAR ACCESS? NO, WE INSERTED A REGULAR PERIPHERAL IV. IF AVAILABLE, PLEASE PROVIDE THE PATIENT AGE, WEIGHT, DIAGNOSIS, AND TREATMENT NEEDED. PNEUMONIA, ANTIBIOTICS. HAS THE PATIENT RECOVERED? IF NO, PLEASE DESCRIBE. THE PATIENT RECOVERED FROM MIDLINE PLACEMENT. WAS A PIECE OF THE MIDLINE RETAINED IN THE PATIENT? IF YES, WAS IT SUCCESSFULLY REMOVED AND BY WHAT MEANS? THE SURGERY TEAM CAME AND DID A CUT DOWN TO RELEASE TH

  Patient problems: Foreign Body In Patient

  MAUDE report 15708837 ↗
• InjuryOct 19, 2022Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  IT WAS REPORTED BY THE CUSTOMER "A 22G 8CM MIDLINE GOT STUCK IN A PATIENT AND HAD TO BE REMOVED WITH SURGERY. THE CATHETER SHEARED OFF OF THE MIDLINE AND THE MIDLINE WAS STUCK. WHEN I DEPLOYED THE GUIDEWIRE, I MET A LITTLE RESISTANCE, SO I STOPPED AND TRIED TO PULL THE MIDLINE OUT. THE CATHETER WAS TWISTED AND BENT LIKE AN ACCORDION." ADDITIONAL INFORMATION PROVIDED (B)(6) 2022: WAS A PIECE OF THE MIDLINE RETAINED IN THE PATIENT? IF YES, WAS IT SUCCESSFULLY REMOVED AND BY WHAT MEANS? THE SURGERY TEAM CAME AND DID A CUT DOWN TO RELEASE THE MIDLINE. THE CATHETER BROKE OFF THE HUB AT THE PATIENT'S INSERTION SITE. AT APPROXIMATELY 1200,THIS RN, ATTEMPTED A MIDLINE INSERTION ON THE LEFT UPPER BASILIC VESSEL IN A STERILE FASHION. AFTER DEPLOYING THE GUIDEWIRE, THE CATHETER WAS THREADED INTO THE VEIN. WHEN TRYING TO REMOVE THE GUIDEWIRE DEVICE, THE CATHETER AND NEEDLE WOULD NOT RELEASE OUT OF THE VESSEL. THE CATHETER SHEARED OFF AT THE LEVEL OF THE SKIN. SURGERY WAS CALLED TO THE BEDSIDE FOR EVALUATION." DID THE EVENT RESULT IN ANY LONG-TERM HARM (IF YES, PLEASE DESCRIBE), OR DID IT RESULT IN A DELAY IN TREATMENT THAT HAD A NEGATIVE IMPACT ON PATIENT OUTCOMES? DELAY IN TREATMENT AND NEGAT

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 15634082 ↗
• MalfunctionSep 22, 2021Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED BY HEALTHCARE PROFESSIONAL "WE HAD A POWERGLIDE ISSUE ON FRIDAY. WENT TO PLACE, SHE SAID THE ACCESS AND WIRE DEPLOYMENT WENT IN FINE WITHOUT FEELING ANY ISSUES. SHE WENT TO THREAD THE CATHETER AND IT DIDN'T GO. ATTEMPTED TO PULL BACK ON THE CATHETER AND WIRE BUT BOTH WERE STUCK. SHE PULLED EVERYTHING OUT ENTIRELY AND FOUND THAT THE WIRE WAS COMPLETELY BENT BACKWARDS, AND THE NEEDLE WAS THROUGH THE CATHETER. THEY DID MEASUREMENTS AND ENSURED EVERYTHING CAME OUT."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12517140 ↗
• InjuryAug 20, 2021Break; Break

  IT WAS REPORTED "THE CATHETER AND GUIDEWIRE BROKE OFF INSIDE THE PATIENT, JUST PAST THE PINK HUB. PT NEEDED IR TO IMAGE THE PATIENT TO FIND THE PIECE LEFT INSIDE."

  Patient problems: Foreign Body In Patient

  MAUDE report 12349458 ↗
• MalfunctionMar 19, 2021Improper or Incorrect Procedure or Method; Activation Problem; Improper or Incorrect Procedure or Method; Activation Problem

  IT WAS REPORTED HAD TROUBLE RETRACTING THE DEVICE, IT DID SAFETY, BUT THE CLINICIAN FELT LIKE IT GOT STUCK ON THE GREEN CLIPS DURING INSERTION AND RETRACTION. ON (B)(6) 2021 -THE RETURNED SAMPLE HAS A PERFORATED CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11531531 ↗
• MalfunctionJan 4, 2021Break; Material Frayed; Physical Resistance/Sticking; Material Frayed

  IT WAS REPORTED VIA MS&S: "CALLER REPORTING A MALFUNCTION WITH A POWERGLIDE PRO MIDLINE CATHETER (REF (B)(4). STATES WHEN NURSING WAS PLACING THE DEVICE THEY WENT TO RETRACT THE GUIDEWIRE AND THEY FELT RESISTANCE. SHE ASKED FOR ANOTHER NURSE TO ASSIST AND THEY WERE ABLE TO REMOVE THE GUIDEWIRE BUT NOTICED IT HAD BROKEN IN HALF. STATES THEY WERE ABLE TO REMOVE ALL THE GUIDEWIRE BUT DID GET A PATIENT X-RAY AND NOTHING WAS FOUND." (B)(6)2020 ADDITIONAL INFO. RECEIVED: "NO PATIENT HARM REPORTED".

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11112371 ↗
• InjuryJun 28, 2019Entrapment of Device; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT AFTER DEPLOYMENT OF THE GUIDEWIRE AND UPON ADVANCEMENT OF THE CATHETER, THE CATHETER WOULD NO LONGER ADVANCE ALONG THE GUIDEWIRE. AS A RESULT, THE TEAM ATTEMPTED TO REMOVE THE ENTIRE DEVICE BUT THE GUIDEWIRE AND CATHETER REMAINED STUCK INSIDE THE PATIENT AND REQUIRED PHYSICIAN CONSULT FOR REMOVAL.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8746239 ↗