Peripheral Catheter Insertion Kit F220108PTRecalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00801741140631), received between Sep 12, 2019 and Jun 30, 2026 — classified as 17 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Break” (17 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 30, 2026Activation Problem

  IT WAS REPORTED THAT POWERGLIDE PRO DOES NOT SAFETY UPON PROCEDURE COMPLETION/NEEDLE RETRACTION. NO OTHER ISSUES WITH PROCEDURE, SAFETY BARREL/CAP PIECE JUST DOES NOT DEPLOY. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25673051 ↗
• MalfunctionMay 5, 2026Fluid/Blood Leak

  IT WAS REPORTED THERE IS A DEFECT IN THE CATHETER ITSELF AT THE HUB-CATHETER CONNECTION. IT IS A VERY SLIGHT HOLD, AND IT LEAKS. LINE LEAKAGE WAS DISCOVERED ON 04/18/26, LINE WAS PLACED ON (B)(6) 2026 (20/10 PG) TO RT BASILIC VEIN. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25086823 ↗
• MalfunctionMay 5, 2026Fluid/Blood Leak

  IT WAS REPORTED A DEFECT IN THE CATHETER ITSELF AT THE HUB-CATHETER CONNECTION. IT IS A VERY SLIGHT HOLD AND IT LEAKS, IT WAS NOT NOTICED UNTIL IT WAS A BLOODY MESS. THERE WAS BLOOD COMING OUT OF THE CONNECTION POINT. THE LINE WAS REPLACED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25086649 ↗
• MalfunctionJan 7, 2026Difficult to Insert

  IT WAS REPORTED BY MEDWATCH WHEN PLACING MIDLINE AND FEEDING CANNULA OVER GUIDEWIRE, RESISTANCE WAS MET AND WHEN RETRACTING THE CANNULA, THE NEEDLE TORE THROUGH THE SIDE OF CANNULA. NO PATIENT HARM, INJURY, OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23991806 ↗
• InjuryDec 19, 2025Material Frayed; Material Frayed

  IT WAS REPORTED WHILE USING THE POWERGLIDE THE NEEDLE WENT THROUGH THE CATHETER. THE GUIDEWIRE GOT STUCK INSIDE THE PATIENT. MAY NEEDED IR TO CONFIRM IF THE GUIDEWIRE WAS TAKEN FULLY OUT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23851823 ↗
• InjuryNov 11, 2025Break; Break

  IT WAS REPORTED THAT A CATHETER WAS SELECTED FOR INSERTION INTO THE RIGHT BASILIC VEIN. THE VEIN WAS VISUALIZED UNDER ULTRASOUND AND ACCESSED SUCCESSFULLY. THE GUIDEWIRE ADVANCED WITHOUT DIFFICULTY. HOWEVER, WHILE ADVANCING THE CATHETER OVER THE NEEDLE AND GUIDEWIRE, THE PATIENT SUDDENLY FLEXED BOTH ARMS FORCEFULLY INWARD. THE CLINICIAN DECIDED TO ABORT THE PROCEDURE IN RESPONSE TO THE ABRUPT MOTION. UPON WITHDRAWAL, IT WAS NOTED THAT THE CATHETER HAD FRACTURED, LEAVING A FRAGMENT OF APPROXIMATELY 3 CM IN PATIENT. CATHETER FRAGMENT RETAINED IN PATIENT'S ARM. VASCULAR SURGERY WAS CONSULTED FOLLOWING CATHETER FRACTURE. AT THE TIME OF THE CONSULT, IT WAS REPORTED TO OUR TEAM THAT THE SURGEON DID NOT RECOMMEND IMMEDIATE REMOVAL. COMPLAINANT CANNOT SAY WHETHER THE CATHETER WAS ULTIMATELY REMOVED. ALTERNATIVE VASCULAR ACCESS WAS ESTABLISHED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23527698 ↗
• MalfunctionNov 6, 2025Break; Break

  IT WAS REPORTED A POWERGLIDE TIP SHEARED OFF WHILE ATTEMPTING TO PLACE. HE STATED HE GOT IN THE VEIN, WIRE ADVANCED AND THEN WHEN HE WENT TO ADVANCE THE CATHETER IT WOULD NOT ADVANCE ALL THE WAY, IT APPEARED THE VESSEL HAS SPASMED DOWN. WHEN HE WENT TO REMOVE THE DEVICE HE FELT SOME RESISTANCE RIGHT AT THE INSERTION SITE AND INSPECTED THE END OF THE CATHETER AND APPEARED A PIECE OF THE TIP WAS SHEARED OFF. THE RETAINED SEGMENT WAS NOT FOUND, UNSURE IF IT BROKE OFF INSIDE OR JUST OUTSIDE THE PATIENT. NO OTHER INTERVENTION WAS NEEDED. NO PATIENT INJURY. UNFORTUNATELY, HE DID NOT SAVE THE DEVICE FOR INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23490258 ↗
• MalfunctionSep 4, 2025Defective Component; Defective Component

  IT WAS REPORTED, PINHOLES IN PROBE COVERS. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22960204 ↗
• MalfunctionAug 25, 2025Activation Problem; Activation Problem

  IT WAS REPORTED, WHEN PULLING OUT THE POWERGLIDE NEEDLE AFTER THREADING THE HUB THAT TYPICALLY HOUSES AND SAFETYS THE NEEDLE TIP BECAME UNATTACHED LEAVING AN EXPOSED SHARP OUT TO THE CLINICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22883972 ↗
• MalfunctionAug 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, DURING ADVANCEMENT, THE GUIDEWIRE CAME OUT OF THE TRACK ON THE BACK OF THE DEVICE. SECOND ATTEMPT NEEDED TO PLACE LINE, PATIENT STUCK A SECOND TIME. NO IMMEDIATE COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22738604 ↗
• InjuryJul 17, 2025Break; Break

  IT WAS REPORTED ATTEMPTING 20G 10CM POWERGLIDE. CATHETER WOULD NOT ADVANCE AFTER THE GUIDE WIRE WAS DEPLOYED. PULLED UNIT OUT OF ARM. NOTICED THE TIP OF THE ANGIO LOOKED DIFFERENT. UPON MEASURING AND COMPARING THE ANGIOCATH. IT APPEARS SHORTER BY 6CM AND TIP DOES NOT LOOK LIKE THE OTHERS. THEY ARE UNABLE TO DETERMINE THE LOCATION OF THE RETAINED CATHETER. IMAGING WAS NOT DONE. RETAINED CATHETER HAS NOT BEEN REMOVED. NO ADVERSE INJURY OR EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22535752 ↗
• MalfunctionMar 25, 2025Defective Component; Defective Component

  IT WAS REPORTED BY MEDWATCH WHEN ATTEMPTING TO PLACE MIDLINE, GUIDEWIRE ADVANCED WITHOUT DIFFICULTY, ATTEMPTED TO ADVANCE CATHETER, RESISTANCE MET, STOPPED ADVANCEMENT OF CATHETER, WHEN ATTEMPTING TO RETRACT GUIDEWIRE FOR REMOVAL OF MIDLINE DEVICE, GUIDEWIRE WOULD NOT RETRACT INTO PROPER POSITION. RESISTANCE FELT WITH REMOVAL OF DEVICE. AFTER REMOVAL OF MIDLINE DEVICE, VISUAL ASSESSMENT REVEALED GUIDEWIRE EXITED THROUGH SIDE OF CATHETER. CATHETER TIP AND GUIDEWIRE REMAINED INTACT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21691999 ↗
• MalfunctionMar 12, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED BY CUSTOMER THAT THEY RECEIVED THEIR ORDER, AND IT SMELLS ROTTEN AND LOOKS LIKE IT HAS MILDEW ON IT. THEY DO NOT WANT TO USE THE PRODUCT AS IT MAY BE A SAFETY HAZARD FOR PATIENTS. NO OTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH TWO CASES. THIS REPORT ADDRESSES BOTH CASES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21590183 ↗
• MalfunctionJan 23, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY THE CUSTOMER, THE POWERGLIDE WAS PLACED AND THEN WHEN FLUSHED THE SALINE WAS ACTUALLY SHOOTING OUT OF THE HUB, NOT INFUSING INTO THE PATIENT. THE ENTIRE PROCEDURE HAD TO DONE OVER AND THE PATIENT HAD TO BE STUCK AGAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21219768 ↗
• MalfunctionNov 1, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY MEDWATCH THAT LEFT BRACHIAL MIDLINE PLACED. IV CONSULTED TO ASSESS UNABLE TO FLUSH MIDLINE. NOTED SMALL KINK AT HUB, LINE POSITIONAL, HOWEVER REDRESSED AND WAS ABLE TO FLUSH AND OBTAIN BLOOD RETURN. IV CONSULTED TO INSERT LINE AS MIDLINE WAS REMOVED DUE TO NOT BEING ABLE TO FLUSH. CN, REPORTS, DAY NURSE REMOVED LINE NOTING MULTIPLE KINKS IN LINE. THIS LINE WAS ONLY 3 DAYS OLD AND KINKED. LINE REMOVED AND A PERIPHERAL IV WAS INSERTED. NO PATIENT HARM REPORTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20588523 ↗
• InjuryOct 20, 2024Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  IT WAS REPORTED BY CUSTOMER THAT RN CALLED TO PLACE MIDLINE. PATIENT WAS PREPPED AND DURING INSERTION THE RN NOTICED BLOOD RETURN ON FIRST ATTEMPT. THE RN ATTEMPTED TO THREAD THE CATHETER BUT NOTICED RESISTANCE. THE RN ATTEMPTED TO RETHREAD THE CATHETER WITH THE NEEDLE. THE RN NOTED THAT THE NEEDLE PIERCED THE SIDE OF THE CATHETER AT THIS TIME. THE RN REMOVED THE NEEDLE FROM THE PATIENT. WHEN ENTIRE APPARATUS WAS REMOVED, THE CATHETER WAS NOTED TO HAVE MULTIPLE CENTIMETERS MISSING WITH CONCERN THE REMAINDER OF THE CATHETER WAS STILL IN THE PATENT. IT DETERMINED THAT A PIECE OF THE LINE WAS STILL IN THE PATIENT'S ARM WHEN THE CRISIS RN KNEW HE WAS NOT IN THE VESSEL HE WITHDREW THE MIDLINE TO FIND 4-5 CM OF THE CATHETER MISSING. HE ESCALATED TO THE PHYSICIAN TEAM, CONSULT TO PEDS SURGERY, XRAY OBTAINED, FAMILY NOTIFIED ETC.

  Patient problems: Foreign Body In Patient

  MAUDE report 20490127 ↗
• MalfunctionSep 20, 2024Defective Component; Defective Component

  IT WAS REPORTED, DURING TRAINING ON VEIN BLOCK, THE WIRE FROM POWER GLIDE WAS MISSING AFTER ACTIVATING SAFETY. PATIENT WAS NOT INVOLVED. WIRE IS NOT IN A PERSON. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20273211 ↗
• MalfunctionSep 19, 2024Fluid/Blood Leak; Improper or Incorrect Procedure or Method; Fluid/Blood Leak; Improper or Incorrect Procedure or Method

  IT WAS REPORTED BY CUSTOMER THAT POWERGLIDE WAS EASILY PLACED BUT UPON ATTACHING EXT SET AND FLUSHING THE DEVICE BLOOD SPRAYED EVERYWHERE OUT FROM THE CATHETER. THERE SEEMS TO BE A HOLE ON THE CATHETER JUST BEFORE THE CATHETER HUB. THE PATIENT IMPACT WAS THAT THE PATIENT HAD TO BE UNNECESSARILY STUCK A SECOND TIME TO PLACE A DIFFERENT CATHETER THAT WAS NOT DEFECTIVE. THERE WAS NO INJURY TO THE PATIENT. NO BLOOD EXPOSURE TO THE NURSE, IT SPRAYED ON THE PATIENT ONLY NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20261482 ↗
• MalfunctionAug 8, 2024Material Deformation; Material Deformation

  IT WAS REPORTED VIA MEDWATCH "BARD POWERGLIDE PRO MIDLINE INSERTED [REDACTED DATE] AT 1418 AND REMOVED [REDACTED DATE] AT 2004 DUE TO OCCLUSION. UPON INSPECTION, IT IS NOTED THERE WERE TWO KINKS, ONE AT THE HUB AND ONCE APPROXIMATELY 2CM FROM HUB. ADDITIONALLY, ANOTHER MIDLINE WAS INSERTED." ADDITIONAL INFORMATION RECEIVED 7/31/2024: IT WAS REPORTED THERE WAS NO PATIENT OR HEALTHCARE PROFESSIONAL HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19939701 ↗
• MalfunctionJul 20, 2024Material Deformation; Material Deformation

  IT WAS REPORTED VIA MEDWATCH THAT DUE TO CONTINUOUS INFUSION PUMP ALARMING, THE MIDLINE WAS REMOVED. NOTED FIBRIN BUILD-UP IN TUBING AND NOTED KINKING AT HUB AND ALONG CATHETER. NO FACTORS LEADING UP TO MIDLINE FAILING. THE PRODUCT IS SUB-OPTIMAL. MIDLINES SHOULD LAST 29 DAYS AND THIS LINE LASTED 1 DAY. PATIENT WAS INCONVENIENCED, REQUIRED A PICC LINE INSERTION. NO SIGNIFICANT HARM. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19787307 ↗
• MalfunctionJul 15, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY MEDWATCH "MIDLINE PLACED. IV THERAPY CONSULTED TWICE DURING ONE SHIFT - UNABLE TO FLUSH. DESPITE REPOSITIONING AND PROPER FLUSHING PRACTICES, MIDLINE WAS NOT PROPERLY FUNCTIONING AND WAS REMOVED. NOTED TWO KINKS IN LINE, ONE AT HUB AND ONE AT APPROX. 5CM. MANUFACTURER STATES THE POWERGLIDE MIDLINE IS GOOD FOR 29 DAYS. PATIENT REQUIRED PIV INSERTION. IN ADDITION, THIS CAUSED DELAY IN IV THERAPIES BEING DELIVERED TO THE PATIENT." NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19742892 ↗
• MalfunctionJul 13, 2024Material Deformation; Material Deformation

  IT WAS REPORTED BY THE MEDWATCH MIDLINE INSERTED. DEVELOPED KINKS AND MALFUNCTIONED AND HAD TO BE REMOVED. PATIENT REQUIRED ADDITIONAL STICKS. NO PATIENT HARM REPORTED. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19736833 ↗
• MalfunctionJul 10, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BY CUSTOMER THAT WHILE PLACING A POWERGLIDE ON A CODE PATIENT THE POWER GLIDE HAD A HOLE WHERE THE CATHETER MEETS THE HUB. THEY NOTICED IT BECAUSE IT WAS LEAKING. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19710731 ↗
• MalfunctionJun 6, 2024Material Frayed; Material Frayed

  IT WAS REPORTED VIA MEDWATCH "INSERTED A 20 GAUGE 10CM EDC INTO PATIENT'S RIGHT BRACHIAL VEIN, THE CATHETER DID NOT SLIDE IN SMOOTH, SO THE MECHANISM WAS REMOVED. UPON INVESTIGATION, THE TIP OF THE WIRE WAS NO LONGER ATTACHED TO THE SAFETY MECHANISM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19477260 ↗
• MalfunctionMay 3, 2024Material Frayed; Material Frayed

  IT WAS REPORTED BY THE CUSTOMER THAT POWERGLIDE WIRE SHEARED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19239366 ↗