PowerPICC CK000588BRecalls & 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 00801741212802), received between Feb 3, 2026 and Feb 3, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak1
Patient problems
- Swelling/ Edema1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 3, 2026Fluid/Blood Leak
IT WAS REPORTED HOLE/TEAR IN BODY OF PICC CATHETER NEAR 10CM MARKER, "BURST" OPEN WHILE IN A PATIENT. LEAKING AT INSERTION SITE WAS NOTICED. LINE WAS PLACED ON (B)(6) 2025, STARTING ON (B)(6) 2025 RED LUMEN GAVE NO BLOOD RETURN AND THIS WAS ALSO REPORTED (B)(6). RED LUMEN WOULD FLUSH BUT NOT HAVE BLOOD RETURN. OTHER LUMENS FLUSHED AND GAVE BLOOD RETURN FINE. NURSE NOTICED CLEAR FLUID LEAKING AROUND INSERTION SITE ON (B)(6) AS WELL AND REPORTED TO PICC TEAM. PICC WAS DC'D. SWELLING AND LEAKING OF THE INSERTION SITE. ON ULTRASOUND THIS VESSEL WAS NOTED AS PARTIALLY NON-COMPRESSIBLE POST CATHETER REMOVAL, WITH NO EVIDENCE OF THROMBOSIS. BEYOND THE ULTRASOUND AND THE SERIES OF EVENTS REPORTED THERE ARE NO OTHER DETAILS KNOWN TO OUR TEAM.
Patient problems: Swelling/ Edema
MAUDE report 24251890 ↗
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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