PowerGlide Midline Catheter M120080Recalls & reported problems
Bard Access Systems, Inc. · PowerGlide 20G 8cm Basic · Class 2
All models of PowerGlide Midline Catheter (12)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00801741075315), received between Nov 2, 2015 and Feb 7, 2019 — classified as 7 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Break” (2 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
- Break2
- Difficult to Remove2
- Positioning Problem2
- Bent1
- Detachment Of Device Component1
- Detachment of Device or Device Component1
- Device Dislodged or Dislocated1
- Fluid/Blood Leak1
Patient problems
- No Known Impact Or Consequence To Patient8
- No Code Available1
- No Consequences Or Impact To Patient1
- No Information1
- Tissue Damage1
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 7, 2019Positioning Problem
IT WAS REPORTED THAT THE NEEDLE WENT THROUGH THE CATHETER. IT WAS STATED THE WINGS OF THE POWERGLIDE DEPLOYED BEFORE THE GUIDEWIRE WAS ENGAGED. IT WAS STATED THIS HAPPENED WITH TWO DEVICES. THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8318962 ↗MalfunctionFeb 7, 2019Material Puncture/Hole; Positioning Problem
IT WAS REPORTED THAT THE NEEDLE WENT THROUGH THE CATHETER. IT WAS STATED THE WINGS OF THE POWERGLIDE DEPLOYED BEFORE THE GUIDEWIRE WAS ENGAGED. IT WAS STATED THIS HAPPENED WITH TWO DEVICES. THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8318960 ↗InjuryApr 19, 2018Break
IT WAS REPORTED THAT THE MIDLINE WAS BEING INSERTED VIA THE BRACHIAL VEIN. THE CATHETER BROKE DURING INSERTION AND 7 CM OF THE CATHETER REMAINED IN THE PATIENT. THE PATIENT UNDERWENT A SURGICAL PROCEDURE TO HAVE CATHETER REMOVED. THE PATIENT DID NOT INCUR ANY INJURY AND IS DOING FINE AFTER HIS SURGICAL PROCEDURE.
Patient problems: No Code Available
MAUDE report 7445484 ↗MalfunctionMar 16, 2018Bent; Kinked
IT WAS REPORTED THAT THE GUIDEWIRE WAS FOUND TO BE KINKED APPROXIMATELY 2 INCHES FROM THE TIP, DESPITE THE INSERTER PROPERLY FOLLOWING ALL PROCEDURES AND IFU DIRECTION. THE INSERTER STATED THAT ¿THERE WAS NO RESISTANCE UPON INSERTION OF CATHETER OR REMOVAL OF WIRE DURING THE PROCEDURE. THE CATHETER WAS TRIMMED PER USUAL ROUTINE AND THE GUIDEWIRE WAS REINSERTED POST SALINE FLUSH PER MANUFACTURER INSTRUCTIONS FOR USE. GUIDEWIRE WAS BENT ON THE RUBBER END CAP FOR SECUREMENT PER IFU. THE PROCEDURE WAS PER NORMAL ROUTINE AND THERE WERE NO CONCERNS ISSUES (WITH THE CATHETER) WARRANTING FURTHER INVESTIGATION. INSERTER STATED THAT THE SHERLOCK SYMBOL (LOLLIPOP) WAS SPOTTY ON THE SCREEN AND THERE WAS NO ECG WAVEFORM. X-RAY WAS REQUIRED TO CONFIRM PLACEMENT. SUCCESSFUL PLACEMENT OF THE PICC WITH NO ADVERSE EFFECTS TO THE PATIENT NOTED.¿
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7345643 ↗InjuryOct 25, 2017Device Dislodged or Dislocated
FACILITY REPORTED TO THE SALES REP THAT THEY HAD A POWERGLIDE CATHETER DISLODGE FROM THE HUB DURING INSERTION. THE CATHETER WAS PLACED IN THE PATIENT'S FOREARM/CEPHALIC. A TOURNIQUET WAS PLACED ABOVE THE SITE TO REDUCE THE CHANCE OF THE CATHETER MIGRATING. PATIENT GOING TO SURGERY FOR REMOVAL. NO INJURY TO PATIENT WAS REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6975994 ↗InjurySep 13, 2017Detachment Of Device Component; Fluid/Blood Leak
IT WAS REPORTED BY THE SALES REP THAT THE FACILITY PLACED A POWERGLIDE INTO THE PATIENT'S RIGHT FOREARM ON (B)(6) 2017. ON (B)(6) 2017, ACCORDING TO THE PATIENT, LEAKING WAS NOTED AFTER FLUSHING. WHEN THE MIDLINE WAS REMOVED BY THE NURSE, THE 8 CM CATHETER WAS DETACHED FROM THE HUB. IT WAS REPORTED THIS WAS WITNESSED BY THE PATIENT. THE PATIENT IS CURRENTLY AWAITING CT SCAN WITH POSSIBLE INTERVENTIONAL RADIOLOGY REMOVAL OF THE CATHETER.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6863656 ↗InjuryFeb 2, 2017Material Fragmentation
IT WAS REPORTED BY THE NURSE AT THE FACILITY THAT AS SHE WAS ADVANCING THE CATHETER IT "BROKE OFF". REQUIRED REMOVAL IN IR, NO PATIENT HARM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6297918 ↗InjuryMar 15, 2016Difficult to Remove
PER MEDWATCH REPORT FROM FACILITY CONTACT, A POWERGLIDE MIDLINE WAS BEING INSERTED INTO THE LEFT UPPER ARM WHEN THE PATIENT SUDDENLY MOVED THEIR ENTIRE BODY AND ARM. MIDLINE BECAME IMBEDDED IN THE LEFT ARM AND PLACER WAS UNABLE TO WITHDRAW THE MIDLINE OR DISENGAGE. SURGERY WAS CONSULTED AND AN INCISION WAS MADE AT THE MIDLINE ENTRY SITE. THE MIDLINE WAS SUCCESSFULLY REMOVED INTACT. ONE SUTURE WAS REQUIRED TO CLOSE INCISION. PATIENT TOLERATED THE PROCEDURE WELL.
Patient problems: Tissue Damage
MAUDE report 5500365 ↗InjuryMar 14, 2016Break
FACILITY CONTACT REPORTED TO SALES REPRESENTATIVE THAT A NURSE HAD A POWERGLIDE WHERE THE CATHETER ALLEGEDLY BROKE OFF JUST BELOW THE HUB AND REQUIRED SURGICAL INTERVENTION TO REMOVE. A NEW POWERGLIDE WAS NOT PLACED IN THE PATIENT AS THE FACILITY DID NOT WANT TO USE THE PRODUCT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5497332 ↗InjuryDec 21, 2015Difficult to Remove
FACILITY CONTACT STATED THAT THIS EVENT WAS REPORTED BY THE IV TEAM. THEY STATED THAT A MIDLINE CATHETER WAS BEING ADVANCED OVER NEEDLE AND GUIDEWIRE BY THE IV TEAM RN, AND THE PATIENT REPORTEDLY BECAME COMBATIVE AND PULLED RIGHT ARM AWAY FROM ICU RN PROCEDURE WAS ABORTED. AS NEEDLE AND CATHETER WERE BEING WITHDRAWN FROM THE ARM, RESISTANCE WAS FELT. IV TEAM NOTED THE CATHETER HAD ALLEGEDLY SHEARED OFF AT APPROXIMATELY THE 0.5 CM MARK. VASCULAR SURGERY WAS CONSULTED AND THE PATIENT WAS TAKEN TO THE OR FOR REMOVAL OF THE RETAINED CATHETER. TEAM REPORTED NO OPERATIVE COMPLICATIONS.
Patient problems: No Information
MAUDE report 5315128 ↗MalfunctionNov 20, 2015Detachment of Device or Device Component
THE FACILITY REPORTS THEY WERE ABLE TO RETRIEVE THE CATHETER WITH STERILE FORCEPS FROM THE DRESSING PACK. A NEW POWERGLIDE WAS PLACED SUCCESSFULLY. THERE WERE NO RESIDUAL CONSEQUENCES TO THE PATIENT ASIDE FROM AN ADDITIONAL NEEDLE PUNCTURE. THE DETACHMENT OCCURRED BETWEEN THE CATHETER AND THE HUB, NOT THE EXTENSION SET.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5241177 ↗MalfunctionNov 2, 2015Uncoiled
IT WAS REPORTED THAT POWERGLIDE INSERTED ON PATIENT, WHEN THE NURSE PULLED BACK ON THE POWERGLIDE DEVICE TO REMOVE IT FROM THE CATHETER THE GUIDE WIRE ALLEGEDLY UNCOILED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5194816 ↗
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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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