Peripheral Catheter Insertion Kit F320088PTRecalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00801741140679), received between Apr 26, 2018 and Sep 23, 2026 — classified as 6 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjurySep 23, 2026Break

  It was reported that the tip of PowerGlide broke off in the patient -1.15cm. No adverse event or serious injury reported. The retained catheter tip was in the tissue. The tip was not removed from patient. No complications or additional intervention needed.

  Patient problems: Foreign Body In Patient

  MAUDE report 50873057 ↗
• MalfunctionApr 1, 2026Fluid/Blood Leak

  IT WAS REPORTED CATHETER DAMAGED BY HUB. SITE WAS LEAKING AT INSERTION SITE-CATHETER HAD DEFECT. HAD TO REMOVE CATHETER AND PLACE NEW MIDLINE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24755453 ↗
• MalfunctionFeb 10, 2026Activation Problem

  IT WAS REPORTED THE NEEDLE DID NOT SAFETY AFTER DEPLOYING CATHETER AND PULLING OUT THE NEEDLE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24309183 ↗
• InjuryJan 6, 2026Break

  IT WAS REPORTED THE DEVICE BROKE OFF IN THE PATIENT. MIDLINE DURING INSERTION THE TIP BROKE OFF IN THE BASILIC VEIN. VASCULAR SURGERY HAD TO BE CONSULTED. PATIENT TAKEN TO SURGERY WHERE THE SURGEON WAS ABLE TO REMOVE THE 4CM PIECE FROM THE BASILIC VEIN. PATIENT DISCHARGE DELAYED BY 48 HOURS DUE TO THE EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23973623 ↗
• InjuryJan 6, 2026Break

  IT WAS REPORTED THE DEVICE BROKE OFF IN THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 23973622 ↗
• InjuryMar 13, 2025Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  IT WAS REPORTED BY CUSTOMER THAT THE CATHETER BROKE AND 2M PORTION REMAINED IN THE PATIENT'S TISSUE. NO FURTHER INFORMATION PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21593727 ↗
• MalfunctionJun 10, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER PLACEMENT DEVICE WAS LEAKING AT INSERTION SITE. UPON REMOVAL, CLINICIANS FOUND THAT IV WAS LEAKING AT JUNCTION OF CANULA AND NOSE OF CATHETER. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19505725 ↗
• MalfunctionApr 1, 2024Difficult to Insert; Defective Component; Difficult to Insert; Defective Component

  IT WAS REPORTED, "PRODUCT BROKEN." NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION PROVIDED 03/15/2024: IT WAS REPORTED, "IN PATIENT VESSEL WHEN FAILURE HAPPENED. WHILE PLACING UNDER ULTRASOUND, GUIDEWIRE WAS ADVANCED (WITHOUT DIFFICULTY) AND WHEN ADVANCING CATHETER, IT WAS NOT ABLE TO ADVANCE. CATHETER RETRACTED TO CHECK FOR TIP PLACEMENT. GUIDEWIRE RETRACTED AS WELL. TIP PLACEMENT CONFIRMED. GUIDEWIRE RE-ADVANCED WITHOUT DIFFICULTY. WHEN RE-ADVANCING CATHETER THE SAME ISSUE WAS NOTED. WHEN REMOVING CATHETER AND NEEDLE AS A FAILED ATTEMPT, IT HAD TO BE PULLED/FORCED OUT (LIKE A BARB) TO BE ABLE TO REMOVE THE NEEDLE FROM THE PATIENTS ARM."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19015471 ↗
• MalfunctionApr 1, 2024Difficult to Insert; Defective Component; Difficult to Insert; Defective Component

  IT WAS REPORTED, "IN PATIENT VESSEL WHEN FAILURE HAPPENED. WHILE PLACING UNDER ULTRASOUND, GUIDEWIRE WAS ADVANCED (WITHOUT DIFFICULTY) AND WHEN ADVANCING CATHETER, IT WAS NOT ABLE TO ADVANCE. CATHETER RETRACTED TO CHECK FOR TIP PLACEMENT. GUIDEWIRE RETRACTED AS WELL. TIP PLACEMENT CONFIRMED. GUIDEWIRE RE-ADVANCED WITHOUT DIFFICULTY. WHEN RE-ADVANCING CATHETER THE SAME ISSUE WAS NOTED. WHEN REMOVING CATHETER AND NEEDLE AS A FAILED ATTEMPT, IT HAD TO BE PULLED/FORCED OUT (LIKE A BARB) TO BE ABLE TO REMOVE THE NEEDLE FROM THE PATIENTS ARM." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19015447 ↗
• MalfunctionJun 23, 2023Material Frayed; Material Frayed

  IT WAS REPORTED BY THE CUSTOMER THAT POWERGLIDE WIRE FRAYED WHILE ATTEMPTING PLACEMENT. NO HARM, A NEW CATHETER WAS INSERTED. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17190909 ↗
• InjuryMay 25, 2023Break; Improper or Incorrect Procedure or Method; Break; Improper or Incorrect Procedure or Method

  IT WAS REPORTED VAT RN ATTEMPTED TO PLACE 8 CM POWERGLIDE MIDLINE. REPORTED TO MANAGER THAT MIDLINE MET RESISTANCE AND WHEN VAT RN REMOVED DEVICE NOTICED TIP OF CATHETER NOT INTACT. FOLLOWED UP WITH POLICIES AND PROCEDURES FOR POSSIBLE DEVICE FRACTURE. NO OTHER INFORMATION PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 17008215 ↗
• MalfunctionJan 25, 2023Defective Component; Defective Component

  IT WAS REPORTED BY THE CUSTOMER "CANNULA OF PG PRO SPLIT AT THE TIP DURING ADVANCING THROUGH THE TISSUE. ACCESS OBTAINED, GUIDE WIRE DEPLOYED EASILY, FELT RESISTANCE ON ADVANCEMENT, NOTICED AT THE SITE OF INSERTION THE CATHETER MATERIAL SEPARATED, DEVICE REMOVED." NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16241509 ↗
• InjuryOct 5, 2022Break; Break

  IT WAS REPORTED BY THE CUSTOMER VIA MEDWATCH "POWERGLIDE MIDLINE DEVICE CAME APART AND UPON REMOVAL OF DEVICE THE CATHETER BROKE OFF AND WAS NOT INTACT. POSSIBLE PIECE BROKE OFF INTO PATIENT'S ARM JUST BENEATH THE SKIN. SONOGRAM REVEALED 0.3CM FOCAL LINEAR ECHOGENICITY WITHOUT SHADOWING OR DOUBLE LINE STRUCTURE OF SUB DERMIS WITHOUT DEMONSTRABLE VASCULARITY. PHYSICIAN PROGRESS NOTE STATES RETAINED PARTIAL IV CATHETER IN RIGHT UPPER ARM, VISIBLE ON ULTRASOUND, NO INTERVENTION PER IR (INTERVENTIONAL RADIOLOGY)"

  Patient problems: Foreign Body In Patient

  MAUDE report 15542597 ↗
• MalfunctionSep 28, 2022Defective Component; Component Missing; Defective Component; Component Missing

  IT WAS REPORTED "CUSTOMER SHARED THAT THE POWERGLIDE PRO RT KIT HAD AN EXTENSION SET THAT WAS MISSING THE PURPLE CLAMP FROM THE LINE. IT WAS REPLACED WITH ANOTHER EXTENSION SET."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15499230 ↗
• MalfunctionSep 7, 2022Break; Break

  IT WAS REPORTED "CUSTOMER PLACED POWERGLIDE AND CATHETER WOULD NOT ADVANCE. WHEN PULLED OUT OF ARM, THE CATHETER WAS SHEARED BY THE NEEDLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15375065 ↗
• MalfunctionDec 8, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED "CUSTOMER SHARED THAT UPON FLUSHING THEY OBSERVED THE EXTENSION FROM THE POWERGLIDE PRO RT LEAKING WITH FLUID."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12961458 ↗
• MalfunctionApr 8, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED "ACCESSED VEIN LIKE NORMAL - DEPLOYED GUIDEWIRE, FELT STIFF WHEN PUSHING IN - ENTIRE NEEDLE DEPLOYED INTO VESSEL. WENT AHEAD AND WITHDREW THE NEEDLE OUT. WAS ABLE TO SAVE THE CATHETER" ADDITIONAL INFORMATION: "THIS WAS AN (B)(6) BEING TREATED FOR A NON-SURGICAL ARM FRACTURE. SHE WAS A POST CODE WHO EVENTUALLY SUCCUMBED TO HER ILLNESS." (B)(6) 2021 THE GUIDEWIRE WAS FOUND TO BE DAMAGED AND THE NEEDLE CANNULA WAS DETACHED FROM THE HOUSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11637850 ↗
• MalfunctionNov 19, 2019Material Frayed; Material Frayed

  IT WAS REPORTED THAT THE POWERGLIDE PRO RT MIDLINE CATHETER SHEARED OR BROKE. 11/8/2019- ADDITIONAL INFORMATION RECEIVED STATED, "CATHETER WAS INSERTED WITH NO NOTICEABLE RESISTANCE. THREADED GUIDEWIRE AND CATHETER AND IT WENT FINE. TRIED TO ASPIRATE AND GOT NO BLOOD RETURN. TRIED TO FLUSH AND COULD NOT FLUSH. PULLED CATHETER OUT OF PATIENT AND THE GUIDEWIRE HAD BROKEN OFF SOMEHOW AND WAS INSIDE THE CATHETER."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9341823 ↗
• MalfunctionMay 21, 2019Infusion or Flow Problem

  IT WAS REPORTED THE TUBING WOULD NOT ALLOW A FLUSH , IT WAS NOT CLAMPED, THEY MADE MULTIPLE ATTEMPTS TO TRY TO FLUSH THROUGH IT. WHEN THEY REMOVED THE TUBING AND CONNECTED THEIR FLUSH TO THE DEVICE THE LINE FLUSHED FINE JUST NOT THROUGH THE TUBING. NO PATIENT HARM REPORTED. POWERGLIDE PLACED IN UPPER ARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8629944 ↗
• MalfunctionDec 14, 2018Material Twisted/Bent; Material Split, Cut or Torn; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING USE OF THE CATHETER THE NURSE FELT RESISTANCE AND INSTINCTIVELY PULLED BACK ON IT AFTER IT WAS DEPLOYED WHICH CAUSED THE CATHETER TO SHEAR, THE GUIDEWIRE BECAME BENT. PATIENT EXPERIENCED TRAUMA BUT NO MAJOR HARM MENTIONED. ON 12/4/18 ADDITIONAL INFORMATION RECEIVED STATED, "THERE WAS NO CUT DOWN, SNARE, SURGICAL REMOVAL NECESSARY TO REMOVE THE DEVICE. THE CLINICIAN FELT RESISTANCE AS SHE WAS ADVANCING THE CATHETER AFTER GUIDEWIRE WAS SUCCESSFULLY DEPLOY. HER INSTINCT WAS TO REMOVE THE ENTIRE DEVICE BUT IN DOING SO SHEARED THE CATHETER. IT WAS DURING REMOVAL THAT THE TIP OF THE GUIDEWIRE WAS HELD UP ON THE PATIENT¿S TISSUE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8164549 ↗
• MalfunctionApr 26, 2018Material Puncture/Hole; Difficult to Remove; Material Separation; Physical Resistance

  IT WAS REPORTED THAT DURING THE INSERTION PROCEDURE THE NURSE WAS ABLE TO THREAD THE GUIDEWIRE WITH NO RESISTANCE. IT WAS STATED SHE DID MEET RESISTANCE WHEN SHE ATTEMPTED TO THREAD THE CATHETER AND SO SHE DECIDED TO REMOVE THE ENTIRE DEVICE. REMOVAL WAS DIFFICULT AND AFTER IT WAS REMOVED THE NURSE FOUND THAT THE GUIDEWIRE HAD PUNCTURED THE CATHETER AND WAS ¿LOOPED¿. THE GUIDEWIRE ALSO SEPARATED FROM THE HOUSING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7466764 ↗