PowerMidline CK000799Recalls & reported problems
Bard Access Systems, Inc. · Catheter Placement Kit · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741144837), received between Feb 6, 2020 and Feb 7, 2020 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Defective Component” (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. How this data works · Data updated Oct 13, 2026.
Most reported problems
Device problems
- Defective Component3
Patient problems
- No Consequences Or Impact To Patient2
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 7, 2020Defective Component; Defective Component
IT WAS REPORTED THE US (ULTRA SOUND) GEL WAS LEAKING THOUGH THE STERILE PROBE COVER THAT CAME WITH THE KIT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9682558 ↗MalfunctionFeb 6, 2020Defective Component; Defective Component
IT WAS REPORTED THAT THE PROBE COVER LEAKED PRIOR TO USE ON PATIENT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Patient Involvement
MAUDE report 9679561 ↗MalfunctionFeb 6, 2020Defective Component; Defective Component
IT WAS REPORTED THAT THE PROBE COVER LEAKED AND WAS NOT USED ON THE PATIENT. NO OTHER INFORMATION PROVIDED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9679560 ↗
Other Midline catheter devices
- Midline Catheter Kit P4154108DBard Access Systems, Inc. · Midline catheter1 recall1 death126 reports
- ARROW IPN921959Teleflex Incorporated · Midline catheter2 recalls0 reports
- Midline Catheter Kit S4153108BDPBard Access Systems, Inc. · Midline catheter1 recall36 reports
- Midline Catheter Kit S4153108DBard Access Systems, Inc. · Midline catheter1 recall32 reports
- Midline Catheter Kit S4153108DGPBard Access Systems, Inc. · Midline catheter1 recall15 reports
- Midline Catheter Kit S4254108BDPBard Access Systems, Inc. · Midline catheter1 recall11 reports
- Midline Catheter Kit P4154108Bard Access Systems, Inc. · Midline catheter1 recall10 reports
- ARROW IPN037698Teleflex Incorporated · Midline catheter1 recall9 reports
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 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