PowerPICC CK000631Recalls & 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
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741126765), received between Mar 3, 2023 and Mar 3, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 3, 2023Material Deformation; Material Deformation
IT WAS REPORTED BY THE CUSTOMER THAT "THERE WAS A 'MUSHROOM' ON PICC INTRODUCER. UNABLE TO PLACE INTRODUCER." ADDITIONAL INFORMATION RECEIVED FEBRUARY 15, 2023: "THERE WAS NO HARM CAUSED TO THE PATIENT. PICC LINE WAS BEING PLACED FOR LONG TERM ANTIBIOTIC THERAPY. AS I ATTEMPTED TO ADVANCE INTRODUCER AFTER SKIN WAS NICKED, THERE WAS NO ADVANCEMENT. I TOOK IT OFF THE WIRE AND INSPECTED IT AND NOTICED THERE WAS A SMALL LIP/BURR ON THE GRAY PORTION. I HAD TO OBTAIN ANOTHER INTRODUCER TO COMPLETE THE PICC."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16479236 ↗
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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