PowerMidline CK000729Recalls & reported problems
Bard Access Systems, Inc. · Catheter Placement Kit · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741138713), received between Jan 13, 2025 and Mar 2, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Difficult or Delayed Separation” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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.
Reports received per month
Recalls naming this device
- May 21, 2026Open, Classified
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Z-2662-2026 · Root cause: Nonconforming Material/Component · FDA record ↗
Most reported problems
Device problems
- Difficult or Delayed Separation1
- Difficult to Remove1
- Material Deformation1
- Product Quality Problem1
- Tear, Rip or Hole in Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 2, 2026Material Deformation
IT WAS REPORTED A DEFECTIVE SHEATH IN A MIDLINE KIT THIS WEEKEND. THERE WAS NO INJURY, THE KIT WAS NOT USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24489452 ↗MalfunctionNov 18, 2025Difficult to Remove; Difficult to Remove
IT WAS REPORTED NURSE HAD A LOT OF DIFFICULTY REMOVING STYLET AS THE "T" CONNECTOR WOULD NOT SEPARATE FROM THE MIDLINE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23584394 ↗MalfunctionOct 29, 2025Product Quality Problem; Tear, Rip or Hole in Device Packaging; Product Quality Problem; Tear, Rip or Hole in Device Packaging
IT WAS REPORTED BY CUSTOMER THAT THE PROBE COVER RIPPED, NOTICED POST PROCEDURE. NO FURTHER DETAILS AVAILABLE OR PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23415222 ↗MalfunctionJan 13, 2025Difficult or Delayed Separation; Difficult or Delayed Separation
IT WAS REPORTED BY CUSTOMER THAT THE LITTLE PIECE JUST BROKE OFF AND THEY WAS STUCK WITH ONE WING AND THE WHOLE GRAY TUBE AROUND THE CATHETER. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21141570 ↗
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 · each recall links to the FDA recall notice
- 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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