PowerPICC CK000776ARecalls & reported problems
Bard Access Systems, Inc. · Catheter Placement Kit · Class 2 · Implant
All models of PowerPICC (118)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741188077), received between Aug 12, 2020 and Nov 13, 2024 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Activation Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Activation Problem3
- Contamination /Decontamination Problem1
- Defective Component1
- Difficult or Delayed Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 13, 2024Defective Component; Defective Component
IT WAS REPORTED BY CUSTOMER THAT SEPTUM ON THE PICC WHERE THE WIRE GOES THROUGH IS DIMPLED INSTEAD OF FLAT. THE WIRE IS SLIDING IN AND OUT VERY EASILY WHEN PLACING THE PICC WHICH IT DIDN¿T BEFORE. THERE WAS NO PATIENT HARM DUE TO THE ISSUE WITH THE SEPTUM. IT DID TAKE MORE TIME TO COMPLETE THE PICC INSERTION AS THE GUIDE WIRE WOULD SLIP IN AND OUT OF THE SEPTUM. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20679003 ↗MalfunctionApr 16, 2024Activation Problem; Activation Problem
IT WAS REPORTED BY CUSTOMER THAT SAFETY DID NOT ENGAGE IN A GREEN SAFETY NEEDLE IN KIT. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19122677 ↗MalfunctionJun 2, 2022Activation Problem; Activation Problem
IT WAS REPORTED "CLINIC HAD A SECURELOC NEEDLE WHERE THE SAFETY MECHANISM SLID ALL THE WAY OFF THE NEEDLES LEAVING IT EXPOSED. NO PATIENTS WERE HARMED, AND NO ONE WAS POKED. "
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14580417 ↗MalfunctionAug 20, 2021Contamination /Decontamination Problem; Difficult or Delayed Separation; Contamination /Decontamination Problem; Difficult or Delayed Separation
IT WAS REPORTED "WE HAD A PEEL AWAY SHEATH THAT HAD A HAIR-LIKE PIECE ATTACHED TO IT." NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12349099 ↗MalfunctionAug 12, 2020Activation Problem; Activation Problem
IT WAS REPORTED THAT THE SAFETY OF THE NEEDLE IN THE PICC KIT WOULD NOT ENGAGE TO THE END OF THE NEEDLE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10399241 ↗
Other Catheter, intravascular, therapeutic, long-term greater than 30 days devices
- Groshong NXT ClearVue Catheter 7617405Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days2 deaths1,708 reports
- Groshong NXT ClearVue Catheter 7655405Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days2 deaths1,536 reports
- PowerPICC Catheter 3174118Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall402 reports
- L-Cath™ S/L PICC S/L 26GA (1.9F) x 30cmArgon Medical Devices, Inc. · Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days2 recalls245 reports
- PowerPICC SOLO2 Catheter 1194108DBard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days2 recalls216 reports
- Broviac 0600520Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall265 reports
- Groshong® Catheter 7717405Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days279 reports
- PowerPICC® Catheters 1174108DBard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall222 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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