PowerGlideRecalls & reported problems across all models
Bard Access Systems, Inc. · 12 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 153
- Deaths reported
- 0
- Injuries reported
- 54
- Recalls
- 0
We found 12 models of PowerGlide by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 153 adverse event reports in the FDA's MAUDE database, received between Oct 24, 2018 and Aug 5, 2026 — classified as 54 injuries, 99 malfunctions.
The most frequently reported specific device problem is “Break” (47 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported PowerGlide problems
Device problems
- Break47
- Fluid/Blood Leak30
- Material Frayed20
- Activation Problem16
- Improper or Incorrect Procedure or Method16
- Defective Component11
- Difficult to Insert8
- Material Deformation8
Patient problems
- No Clinical Signs, Symptoms or Conditions73
- Foreign Body In Patient51
- Infiltration into Tissue5
- No Known Impact Or Consequence To Patient5
- Device Embedded In Tissue or Plaque4
- Discomfort4
- Insufficient Information4
- Pain4
PowerGlide models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PowerGlide F120100TCatheter,intravascular,therapeutic,short-term less than 30 days42 reports
- PowerGlide F120080TCatheter,intravascular,therapeutic,short-term less than 30 days39 reports
- PowerGlide F118100TCatheter,intravascular,therapeutic,short-term less than 30 days28 reports
- PowerGlide F122080TCatheter,intravascular,therapeutic,short-term less than 30 days18 reports
- PowerGlide F118080TCatheter,intravascular,therapeutic,short-term less than 30 days10 reports
- PowerGlide F118101TCatheter,intravascular,therapeutic,short-term less than 30 days4 reports
- PowerGlide F218101TCatheter,intravascular,therapeutic,short-term less than 30 days4 reports
- PowerGlide F120081TCatheter,intravascular,therapeutic,short-term less than 30 days3 reports
- PowerGlide F120101TCatheter,intravascular,therapeutic,short-term less than 30 days2 reports
- PowerGlide F118081TCatheter,intravascular,therapeutic,short-term less than 30 days1 report
- PowerGlide F220081TCatheter,intravascular,therapeutic,short-term less than 30 days1 report
- PowerGlide F118101DTCatheter,intravascular,therapeutic,short-term less than 30 days1 report
Recent PowerGlide adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 5, 2026Break
It was reported by the customer that Powerglide shearing off the tip yesterday and getting stuck in a patient.Additional information received:It was retained in the tissue per CT scan. It was not removed. They monitored patient for multiple days and patient had no symptoms and the vascular surgery provider recommended no follow up surgery. During insertion, guidewire mechanism was engaged with no resistance but attempt to move midline mechanism forward and halfway in met resistance. Attempted to retract and was met again with resistance. Midline was removed entirely with the retracting resistance. They had done a CT scan that had shown it in patient arm, venogram was done to confirm it was not in the vein. No additional intervention aside from the diagnostic testing post procedure for catheter location. No further details provided.
Patient problems: Foreign Body In Patient
MAUDE report 50144100 ↗MalfunctionMay 19, 2026Material Frayed
IT WAS REPORTED BY MEDWATCH AFTER GUIDEWIRE WAS ADVANCED BY 60-70%, UNABLE TO ADVANCE ANY FURTHER DUE TO RESISTANCE. ON ATTEMPT TO PULL BACK, THERE WAS RESISTANCE AND WAS NOT ABLE TO PUSH FORWARD OR PULL BACK. WHEN FINALLY REMOVED, THE TIP OF THE GUIDE WIRE BROKE OFF. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 25220066 ↗MalfunctionMay 19, 2026Product Quality Problem
IT WAS REPORTED MIDLINE PLACED IN PATIENT AND UPON REMOVAL OF DEVICE THE CLINICIAN NOTICED THERE WAS NO GUIDEWIRE EXTENDING BEYOND THE NEEDLE LIKE NORMAL. XRAY PERFORMED TO SEE IF WIRE WAS IN PATIENT, BUT NO EVIDENCE. UPON INSPECTING DEVICE, THEY NOTICED WHAT APPEARED TO BE WIRE SEMI-COILED IN THE BACK ON THE DEVICE. PATIENT NEEDED A NEW MIDLINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25219748 ↗InjuryMay 1, 2026Material Frayed
IT WAS REPORTED THAT ON (B)(6) 2025, THE PICU FELLOW NOTED THAT THE GUIDEWIRE BROKE INSIDE THE PATIENT DURING A MIDLINE PLACEMENT ATTEMPT. THE GUIDEWIRE WAS SUCCESSFULLY RETRIEVED, AND AN X-RAY CONFIRMED COMPLETE REMOVAL. THERE WAS NO FURTHER ESCALATION OR HARM CAUSED TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25057675 ↗InjuryApr 28, 2026Material Frayed
IT WAS REPORTED THE TIP FROM THE POWERGLIDE ACTUALLY GOT SHEERED OFF AND STUCK IN THE PATIENTS VESSEL. THE NURSE PLACED THE LINE "ONLY ADVANCED 60% OF THE WIRE¿, MET RESISTANCE ADVANCING THE CATHETER AND COULD NOT ADVANCE ANY FURTHER, PULLED THE LINE OUT WHOLE, DID NOT SEE THAT PART OF THE CATHETER WASN¿T ATTACHED FULLY BUT NOTICED LATER THAT SOMETHING WAS WRONG (AFTER THE NURSE PLACED A NEW LINE ON THE OTHER SIDE). HE STATED THE GUIDEWIRE WAS WEIRD, LOOKED LIKE THE END OF THE CATHETER WAS MISSING. ULTRASOUND WAS ORDERED, WHICH SAW THE CATHETER IN THE PATIENT¿S ARM. PATIENT WENT IN FOR AN ANGIOCATH PROCEDURE, AND THEY WERE UNABLE TO SEE THE CATHETER AT THAT TIME WHILE DOING THE PROCEDURE. THEY STATED THAT THEY DIDN¿T GO LOOKING FOR THE CATHETER, THE PATIENT WAS LATE DISCHARGE.
Patient problems: Foreign Body In Patient
MAUDE report 25016695 ↗MalfunctionApr 13, 2026Activation Problem
IT WAS REPORTED SAFETY MECHANISM FAILED TO DEPLOY. NO PATIENT OR USER IMPACT. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24863015 ↗InjuryMar 4, 2026Break
IT WAS REPORTED WE HAD A POWERGLIDE BREAK OFF IN A PATIENT TODAY. WE HAD TO CALL SURGERY. IT WAS ABOUT 4.5CM THAT BROKE OFF. THEY HAD TO CUT A KNICK IN SKIN TO PULL IT OUT. MY NURSE COULD NOT ADVANCE AFTER SHE PULLED OUT GUIDEWIRE AND NEEDLE. SHE WENT TO PULL IT OUT SLOWLY. THERE WAS NO RESISTANCE. IT JUST BROKE OFF. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 24505646 ↗InjuryFeb 18, 2026Break
IT WAS REPORTED POWERGLIDE PRO MIDLINE CATHETER 20GUAGE, 8CM TIP BROKEN. THE PATIENT WAS QUICKLY TAKEN TO OR FOR SURGICAL REMOVAL OF THE FOREIGN BODY. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 24383066 ↗MalfunctionFeb 9, 2026Fluid/Blood Leak
IT WAS REPORTED, HOLE IN THE CATHETER HUB. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24290998 ↗InjuryFeb 3, 2026Break
IT WAS REPORTED THE CATHETER BROKE INSIDE THE PATIENT¿S ARM DURING INSERTION. SHE STATED THAT THIS IS THE ONLY INCIDENT OF THIS KIND AND THAT THE SAME CLINICIAN HAD SUCCESSFULLY INSERTED ANOTHER CATHETER EARLIER THE SAME DAY WITHOUT ANY ISSUES. THE CATHETER WAS REMOVED BY AN INTERVENTIONAL RADIOLOGIST. THERE WERE NO COMPLICATIONS DURING OR FOLLOWING THE PROCEDURE. THE MIDLINE WAS REPLACED IN THE IR DEPARTMENT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 24251497 ↗MalfunctionJan 15, 2026Break
IT WAS REPORTED THAT A PIECE OF THE ATTACHED MIDLINE CATHETER BROKE AND REMAINED IN THE PATIENT DURING INSERTION PROCESS REQUIRING VASCULAR CONSULT. NO FURTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH FOUR DEVICES. THIS REPORT ADDRESSES ALL FOUR DEVICES.
Patient problems: Insufficient Information
MAUDE report 24082853 ↗MalfunctionJan 13, 2026Misassembled; Activation Problem
IT WAS REPORTED THAT AS WE WERE PLACING POWERGLIDES TODAY ONE OF THEM HAD THE SAFETY MECHANISM BROKEN IN IT. WE CHECKED THE WIRE PRIOR TO INSERTION, AND ALL MOVED SMOOTHLY. UPON INSERTING THE NEEDLE AND THEN ADVANCING THE CATHETER INTO THE VEIN, AS THE NURSE RETRACTED THE HOUSING TO SAFETY THE NEEDLE, THE PLASTIC PIECE THAT IS SUPPOSED TO ENCOMPASS THE NEEDLE TIP BROKE INTO TWO PLACES AND NEVER SAFETIED THE NEEDLE. THE BACK PART OF THE PLASTIC STAYED IN THE BACK OUT THE CATHETER HOUSING. NO FURTHER DETAILS AVAILABLE OR PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24059216 ↗InjuryJan 6, 2026Break
IT WAS REPORTED THAT A PIECE OF THE ATTACHED MIDLINE CATHETER BROKE AND REMAINED IN THE PATIENT DURING INSERTION PROCESS REQUIRING VASCULAR CONSULT. NO FURTHER DETAIL PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 23983321 ↗MalfunctionJan 5, 2026Activation Problem
IT WAS REPORTED, THERE IS NO NEEDLE GUARD PRESENT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23957591 ↗MalfunctionDec 12, 2025Product Quality Problem; Material Deformation; Product Quality Problem; Material Deformation
IT WAS REPORTED THAT A POWERGLIDE MIDLINE WAS INSERTED, BUT THE LUER LOCK HAD SOME FORM OF DEFECT. THE THREADS ON THE LUER LOCK WERE MALFORMED, PREVENTING CONNECTION OF A CLAVE OR EXTENSION LOOP TO THE MIDLINE CATHETER. ULTIMATELY, THE MIDLINE HAD TO BE PULLED AND REPLACED. NO SIGNIFICANT HARM WAS REPORTED; HOWEVER, THE PATIENT REQUIRED A SECOND VENIPUNCTURE TO REPLACE THE DEFECTIVE MIDLINE WITH A FUNCTIONAL DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23789056 ↗
Other Bard Access Systems, Inc. products
- Port Access Needle122 models · 3,744 reports · 3 recalls
- Groshong NXT ClearVue Catheter8 models · 3,266 reports
- PowerPort ClearVUE27 models · 1,993 reports · 15 recalls
- Site~Rite 8 Ultrasound System11 models · 1,965 reports
- PowerPort M.R.I., ChronoFlex22 models · 1,642 reports · 1 recall
- PowerPICC Provena116 models · 1,337 reports · 2 recalls
- PowerPort M.R.I., Groshong10 models · 1,285 reports
- Navarre15 models · 1,228 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page