PowerMidline CK000798Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741144806), received between Aug 13, 2019 and Aug 13, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Material Frayed1
- Retraction Problem1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 13, 2019Break; Material Frayed; Retraction Problem
IT WAS REPORTED THAT THE RN ATTEMPTED TO PLACE MIDLINE CATHETER. IT WAS STATED THAT THE RN REMOVED THE INTRODUCER NEEDLE, INSERTED THE DILATOR/INTRODUCER SHEATH AND ATTEMPTED TO REMOVE THE WIRE BUT IT WAS STUCK. THE RN PULLED ON THE WIRE AND THE END BROKE OFF INSIDE THE PATIENT. THE RN PLACED A TOURNIQUET AT TOP OF ARM AND NOTIFIED PHYSICIAN. IT WAS STATED THAT THE RN DID NOT TRY TO REMOVE THE WIRE WHEN THE NEEDLE WAS IN PLACE. ON 8/1/2019- ADDITIONAL INFORMATION REPORTED STATED, "THE PATIENT WAS SENT TO THE HOSPITAL AND CLEARED AND NO NEGATIVE OUT COMES WERE HAD. THE GUIDEWIRE WAS FRAYED."
Patient problems: Foreign Body In Patient
MAUDE report 8889011 ↗
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.
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