PowerGlide Midline Catheter M118100Recalls & reported problems
Bard Access Systems, Inc. · PowerGlide Midline Catheter 18G, 10cm with Basic Tray · Class 2
All models of PowerGlide Midline Catheter (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00801741038105), received between Dec 9, 2015 and Sep 18, 2023 — classified as 1 injury, 10 malfunctions.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (3 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
Device problems
- Device Operates Differently Than Expected3
- Failure to Advance2
- Break1
- Defective Component1
- Detachment Of Device Component1
- Hole In Material1
- Material Frayed1
- Material Twisted/Bent1
Patient problems
- No Known Impact Or Consequence To Patient7
- No Information2
- No Clinical Signs, Symptoms or Conditions1
- No Code Available1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2023Defective Component; Defective Component
IT WAS REPORTED BY CUSTOMER THAT THE POWERGLIDE GUIDEWIRE DID NOT THREAD. PATIENT ALMOST MISSED THE PG PLACEMENT DUE TO GUIDEWIRE LOCKING OUT. RESPONSE RECEIVED (B)(6) 2023. I DON'T HAVE A LOT NUMBER, AND THE ONLY DISRUPTION WAS IT NEARLY CAUSED THE CLINICIANS TO MISS THEIR STICK ATTEMPT. THEY DID HOWEVER END UP EVENTUALLY SUCCESSFULLY PLACING THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17768677 ↗MalfunctionAug 23, 2018Material Twisted/Bent; Physical Resistance/Sticking
IT WAS REPORTED VIA SALES REP FROM FACILITY THAT "MID LINE WAS BEING PLACED IN THE CEPHALIC VEIN, WIRE WOULD NOT DEPLOY DUE TO RESISTANCE MET , WIRE DID NOT LOCK INTO PLACE DUE TO RESISTANCE MET IMMEDIATELY, WIRE WAS PULLED BACK AND CATHETER WAS REPOSITIONED VIA ULTRA SOUND GUIDANCE, WIRE DEPLOYED AND CATHETER ADVANCED WITHOUT RESISTANCE, CATHETER WOULD NOT FLUSH AND WAS PULLED OUT, DISTAL TIP OF CATHETER KINKED APPROXIMATELY 1 CM FROM THE END OF THE CATHETER."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7811517 ↗InjuryJun 1, 2018Detachment Of Device Component; Noise, Audible
IT WAS REPORTED THAT THE INSERTION OF THE MIDLINE WAS SUCCESSFUL WITH NO ISSUES. DIRECTLY AFTER INSERTION, THE NURSE LIFTED THE CATHETER AT THE HUB TO PLACE A STATLOCK AND HEARD A POP. THE FACILITY STATED THAT, ¿THE POP SOUND IS ASSUMED TO BE THE HUB SEPARATING FROM THE CATHETER ITSELF.¿ THE PATIENT HAD TO GO TO IR TO HAVE PRODUCT REMOVED. THEY ALSO NOTED THAT THEY PUT A TOURNIQUET ON THE PATIENT TO "KEEP CATHETER FROM MIGRATING." NO PATIENT INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7561269 ↗MalfunctionApr 23, 2018Failure to Advance; Device Operates Differently Than Expected
IT WAS REPORTED THAT THE NURSE PLACING THE LINE NOTED THAT AS HE STARTED TO ADVANCE THE CATHETER THERE WAS A SLIGHT TIGHTNESS AND THEN IT STOPPED ADVANCING . IT WAS STATED THE NURSE THEN STARTED TO PULL THE CATHETER BACK OVER THE GUIDEWIRE AND IT WOULD NOT PULL BACK, THE PATIENT COMPLAINED OF IT HURTING, SO HE PULLED THE ENTIRE LINE OUT. THE GUIDEWIRE WAS FULLY ADVANCED INTO PLACE. ONCE PULLED OUT IT WAS NOTED THAT THE GUIDEWIRE HAD PIERCED THE CATHETER.
Patient problems: No Code Available
MAUDE report 7450643 ↗MalfunctionDec 15, 2017Retraction Problem
VASCULAR ACCESS RN WAS PLACING A MIDLINE PICC IN AN ARM VEIN. THE ARM WAS PREPPED, AND THE CATHETER WAS ADVANCED OVER THE GUIDE WIRE WITHOUT RESISTANCE. ON WITHDRAWAL OF THE GUIDE WIRE HOLDER, THE WIRE WAS NOT VISIBLE AT THE END OF THE HOLDER. FOR SOME REASON, THE GUIDE WIRE HAD RETRACTED, AND IT WAS NOT VISIBLE TO THE RN. THERE WAS INITIAL CONCERN THAT THE GUIDE WIRE HAD BROKEN OFF INSIDE THE PT'S VEIN, BUT THIS WAS DETERMINED TO BE WRONG. THIS MIDLINE PICC ACTED IN A DIFFERENT WAY TO WHAT IS STANDARD IN THESE CATHETERS.
Patient problems: No Information
MAUDE report 7124306 ↗MalfunctionJun 15, 2017Device Operates Differently Than Expected
THE FACILITY REPORTED TO THE BARD SALES REPRESENTATIVE THAT THE SAFETY MECHANISM DID NOT ENGAGE ON THE POWERGLIDE DEVICE, AFTER PLACEMENT OF THE CATHETER. NO PATIENT INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6644541 ↗MalfunctionDec 27, 2016Material Frayed
ADDITIONAL INFORMATION RECEIVED: ON OR AROUND (B)(6) 2016, THE PHYSICIAN PLACED DEVICE WITH SOME DIFFICULTY. THE GUIDEWIRE WAS UNWOUND LIKE A SPRING. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Information
MAUDE report 6205946 ↗MalfunctionApr 15, 2016Break; Failure to Advance
ON (B)(6) 2016- PER BARD RN REPORT: A PICC NURSE STATED THAT WHILE PLACING A POWERGLIDE, SHE PULLED BACK ON THE CATHETER WHILE NOT HOLDING THE WHITE HANDLES IN PLACE AND THEN READVANCED THE NEEDLE INTO THE TISSUE. SHE THEN REMOVED THE DEVICE AFTER THE WIRE REPORTEDLY COULD NOT BE DEPLOYED. SHE THEN NOTED A CATHETER SHEAR.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5582748 ↗MalfunctionApr 6, 2016Device Operates Differently Than Expected
ON (B)(6) 2016 - IT WAS REPORTED BY COMPLAINANT, THAT WHEN ADVANCING THE IV CATHETER ALONG THE NEEDLE-INTRODUCER/GUIDEWIRE, THEY NOTED A SUBTLE POP AS THE HUB WAS APPROACHING THE INSERTION SITE. THE PLACER WITHDREW THE INTRODUCER TO THE NORMAL POINT WHERE THEY SEE THE BLOOD RETURN/FLASH AND NOTED THAT THEY HAD GOOD FLASH. THE USER THEN PROCEEDED TO REMOVE THE INTRODUCER ENTIRELY. UPON REMOVAL, THEY NOTED THAT THE GUIDEWIRE WAS MISSING. THE DOCTORS PRESENT WERE NOTIFIED AND AN X-RAY WAS ORDERED. SIMULTANEOUSLY, THE PLACER CONTACTED BARD AND GOT IN TOUCH WITH THE ON-CALL CLINICAL SUPPORT TEAM. PLACER REPORTED THAT IT DID NOT APPEAR ON IMAGING THAT THE GUIDEWIRE WAS IN THE PATIENT'S ARM. UPON FURTHER INVESTIGATION THE GUIDEWIRE WAS LOCATED IN THE IV CATHETER, AGAIN WHICH HAD BEEN REMOVED FROM THE PATIENTS ARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5550319 ↗MalfunctionMar 4, 2016Hole In Material
PER SALES REPRESENTATIVE, NURSE REPORTED THAT THEY HAD A POWERGLIDE WITH A HOLE IN THE CATHETER AT THE STRAIN RELIEF. THE CATHETER WAS REMOVED FROM THE PATIENT AND A NEW ONE WAS PLACED OK. NO PATIENT INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5482046 ↗MalfunctionDec 9, 2015Physical Resistance
(B)(6) 2015 - IT WAS STATED THAT THE NURSE GOT ACCESS, SAW A BLOOD RETURN AND STARTED TO DEPLOY THE WIRE WITHOUT ANY RESISTANCE. ABOUT HALFWAY THROUGH THE DEPLOYMENT, THE WIRE REPORTEDLY MET RESISTANCE. AT THAT POINT, THE NURSE TRIED TO REMOVE THE POWERGLIDE AND NOTICED THE WIRE WAS ALLEGEDLY GONE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5282257 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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