PowerMidline CK000805Recalls & reported problems
Bard Access Systems, Inc. · Catheter Placement Kit · Class 2
All models of PowerMidline (15)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741147517), received between May 10, 2019 and May 10, 2019 — classified as 4 injuries.
The most frequently reported specific device problem is “Break” (4 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
- Break4
- Detachment of Device or Device Component4
Patient problems
- Foreign Body In Patient4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
InjuryMay 10, 2019Break; Detachment of Device or Device Component
IT WAS REPORTED THAT WHEN ATTEMPTING TO PLACE A MIDLINE, THE GUIDEWIRE BROKE AND PART OF THE BROKEN GUIDEWIRE REMAINED IN THE PATIENT. IT IS STATED THAT THE PIECE OF GUIDEWIRE WAS PULLED OUT OF THE PATIENT AND AN X-RAY WAS DONE TO ENSURE THAT NO PIECES REMAINED IN THE PATIENT. NO OTHER INFORMATION WAS PROVIDED. IT WAS STATED THAT THIS OCCURRED THREE SEPARATE TIMES. THIS REPORT ADDRESSES THE SECOND DEVICE.
Patient problems: Foreign Body In Patient
MAUDE report 8599819 ↗InjuryMay 10, 2019Break; Detachment of Device or Device Component
IT WAS REPORTED THAT WHEN ATTEMPTING TO PLACE A MIDLINE, THE GUIDEWIRE BROKE AND PART OF THE BROKEN GUIDEWIRE REMAINED IN THE PATIENT. IT IS STATED THAT THE PIECE OF GUIDEWIRE WAS PULLED OUT OF THE PATIENT AND AN X-RAY WAS DONE TO ENSURE THAT NO PIECES REMAINED IN THE PATIENT. NO OTHER INFORMATION WAS PROVIDED. IT WAS STATED THAT THIS OCCURRED THREE SEPARATE TIMES. THIS REPORT ADDRESSES THE THIRD DEVICE.
Patient problems: Foreign Body In Patient
MAUDE report 8599817 ↗InjuryMay 10, 2019Break; Detachment of Device or Device Component
IT WAS REPORTED THAT WHEN ATTEMPTING TO PLACE A MIDLINE, THE GUIDEWIRE BROKE AND PART OF THE BROKEN GUIDEWIRE REMAINED IN THE PATIENT. IT IS STATED THAT THE PIECE OF GUIDEWIRE WAS PULLED OUT OF THE PATIENT AND AN X-RAY WAS DONE TO ENSURE THAT NO PIECES REMAINED IN THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Foreign Body In Patient
MAUDE report 8599619 ↗InjuryMay 10, 2019Break; Detachment of Device or Device Component
IT WAS REPORTED THAT WHEN ATTEMPTING TO PLACE A MIDLINE, THE GUIDEWIRE BROKE AND PART OF THE BROKEN GUIDEWIRE REMAINED IN THE PATIENT. IT IS STATED THAT THE PIECE OF GUIDEWIRE WAS PULLED OUT OF THE PATIENT AND AN X-RAY WAS DONE TO ENSURE THAT NO PIECES REMAINED IN THE PATIENT. NO OTHER INFORMATION WAS PROVIDED. IT WAS STATED THAT THIS OCCURRED THREE SEPARATE TIMES. THIS REPORT ADDRESSES THE FIRST DEVICE.
Patient problems: Foreign Body In Patient
MAUDE report 8599612 ↗
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 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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