PowerMidline CK001029Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741223945), received between Apr 19, 2023 and May 12, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Defective Component” (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
- Defective Component1
- Material Deformation1
- Tear, Rip or Hole in Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Unspecified Tissue Injury1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 12, 2023Defective Component; Tear, Rip or Hole in Device Packaging; Defective Component; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS A HOLE IN THE WRAPPING ON THE OUTSIDE OF THE TRAY. THERE WAS NO PATIENT HARM ONLY HAVING TO OPEN ANOTHER KIT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16924517 ↗MalfunctionApr 19, 2023Material Deformation; Material Deformation
IT WAS REPORTED BY THE CUSTOMER THAT "INTRODUCER WILL NOT INSERT EASILY INTO VESSEL DURING PICC PROCEDURE. CAUSING MAJOR TRAUMA TO VASCULATURE". ADDITIONAL INFORMATION RECEIVED 04/07/2023: OPENED ANOTHER INTRODUCER KIT AND PLACED THE LINE. THERE WERE NO COMPLICATIONS SECONDARY TO THE VESSEL TRAUMA.
Patient problems: Unspecified Tissue Injury
MAUDE report 16769491 ↗
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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