Statlock IV IV0225Recalls & reported problems
Bard Access Systems, Inc. · StatLock IV Plus Trapezoidal pad, clamshell retainer, macro bore 6in Luer lock extension set 25 box · Class 2
All models of Statlock IV (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00801741081712), received between Apr 27, 2017 and Jun 13, 2023 — classified as 14 malfunctions.
The most frequently reported specific device problem is “Break” (9 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
Device problems
- Break9
- Loose or Intermittent Connection3
- Detachment Of Device Component2
- Detachment of Device or Device Component2
- Fluid/Blood Leak2
- Disconnection1
- Leak/Splash1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- No Known Impact Or Consequence To Patient6
- Insufficient Information1
- No Information1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 13, 2023Break; Break
IT WAS REPORTED, "TUBING IS COMING AWAY FROM HUB/SNAPPING OFF. INCIDENT HAPPENED ON WARD AND ATTACHED TO PATIENT." NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 17122284 ↗MalfunctionJun 8, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY THE CUSTOMER "PATIENT WAS INACTIVE / NOT MOBILE AND EXTENSION SET HAD BECOME FRACTURED. THIS CAUSED BLOOD TO LEAK FROM THE CATHETER POSING DANGER TO PATIENT." NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17086743 ↗MalfunctionApr 22, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY HEALTHCARE PROFESSIONAL "YESTERDAY WE HAD A MIDLINE EXTENSION SET SNAP IN HALF. IT PURPLE COLOURED PIECE WAS STILL SCREWED TO THE MIDLINE AND THE CLEAR TUBING PART HAD COME AWAY FROM THAT. IT WAS ALL STILL CONTAINED UNDER THE ORIGINAL DRESSING FROM THE LINE INSERTION SO COULDN¿T HAVE BEEN MESSED WITH BY STAFF OR PATIENT."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14189220 ↗MalfunctionAug 25, 2021Break; Break
IT WAS REPORTED THAT TWO ¿POWERGLIDE MIDLINE EXTENSION SET BECAME DISCONNECTED, WHEN PULLED OR CAUGHT, LEAVING THE CATHETER OPEN TO AIR. THE DISCONNECTION OCCURRED WHERE THE INFLEXIBLE PROXIMAL END (NEAR THE LUER LOCK) IS JOINED TO THE FLEXIBLE, LONGER, DISTAL PART, THAT HOUSES THE EXTERNAL CLAMP. THIS REPOT ADDRESSES THE SECOND DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12366108 ↗MalfunctionAug 25, 2021Break; Break
IT WAS REPORTED THAT TWO ¿POWERGLIDE MIDLINE EXTENSION SET BECAME DISCONNECTED, WHEN PULLED OR CAUGHT, LEAVING THE CATHETER OPEN TO AIR. THE DISCONNECTION OCCURRED WHERE THE INFLEXIBLE PROXIMAL END (NEAR THE LUER LOCK) IS JOINED TO THE FLEXIBLE, LONGER, DISTAL PART, THAT HOUSES THE EXTERNAL CLAMP. THIS REPOT ADDRESSES THE FIRST DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12366105 ↗MalfunctionAug 19, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component
IT WAS REPORTED THAT THE ¿POWERGLIDE MIDLINE EXTENSION SET BECAME DISCONNECTED, WHEN PULLED OR CAUGHT, LEAVING THE CATHETER OPEN TO AIR. THE DISCONNECTION OCCURRED WHERE THE INFLEXIBLE PROXIMAL END (NEAR THE LUER LOCK) IS JOINED TO THE FLEXIBLE, LONGER, DISTAL PART, THAT HOUSES THE EXTERNAL CLAMP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12343078 ↗MalfunctionMar 26, 2021Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT DURING ADMINISTRATION OF CT THE LINE (EXTENSION SET) FRACTURED. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11576043 ↗MalfunctionMay 9, 2019Disconnection
IT WAS REPORTED THAT THE CONNEXION BETWEEN THE TUBE ANT THE CATHETER (POWER GLICE PRO) IS BROKEN. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8597402 ↗MalfunctionJan 3, 2019Leak/Splash
IT WAS REPORTED, AN ALLEGED LEAK AT THE LEVEL OF "PERFUSION" NEAR THE CATHETER.
Patient problems: No Information
MAUDE report 8214530 ↗MalfunctionSep 29, 2017Break; Loose or Intermittent Connection
IT WAS REPORTED THAT THE HUB ON THE TUBE IS BROKEN AND LOOSE. NO OTHER INFORMATION WAS PROVIDED. NO PATIENT INJURY REPORTED. THIS FILE ADDRESSES THE SECOND OF TWO DEVICES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6904907 ↗MalfunctionSep 29, 2017Break; Loose or Intermittent Connection
IT WAS REPORTED THAT THE HUB ON THE TUBE IS BROKEN AND LOOSE. NO OTHER INFORMATION WAS PROVIDED. NO PATIENT INJURY REPORTED. THIS FILE ADDRESSES THE THIRD DEVICE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6904906 ↗MalfunctionSep 29, 2017Break; Loose or Intermittent Connection
IT WAS REPORTED THAT THE HUB ON THE TUBE IS BROKEN AND LOOSE. NO OTHER INFORMATION WAS PROVIDED. NO PATIENT INJURY REPORTED. THIS FILE ADDRESSES THE FIRST OF TWO DEVICES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6904734 ↗MalfunctionApr 27, 2017Break; Detachment Of Device Component; Use of Device Problem
IT WAS REPORTED THAT THE EXTENSION TUBING HAS SNAPPED - THE PATIENT PULLED ON IT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6525702 ↗MalfunctionApr 27, 2017Break; Detachment Of Device Component
IT WAS REPORTED THAT THE EXTENSION TUBING HAS SNAPPED - CAUSE UNKNOWN.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6525699 ↗
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- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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