PowerPICC SOLO CK000313Recalls & reported problems
Bard Access Systems, Inc. · Catheter Placement Kit · Class 2 · Implant
All models of PowerPICC SOLO (78)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741029028), received between Jul 19, 2016 and Jul 19, 2016 — classified as 6 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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.
Most reported problems
Device problems
- Insufficient Device Problem Information5
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Thromboembolism3
- Thrombosis3
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryJul 19, 2016Insufficient Device Problem Information
ON 06/24/2016- PER SALES REPRESENTATIVE USER FACILITY REPORTED THAT THEY ARE SEEING AN INCREASE IN PATIENTS WITH PICCS REQUIRING TREATMENT FOR UPPER EXTREMITY VTE. THE FACILITY STATED THAT THEY ARE CONCERNED THAT THE REVERSE TAPER AND 7CM INTRODUCER ASSOCIATED WITH THE KIT IS CONTRIBUTING. THIS CATHETER WAS IN THE PATIENT FOR 40 DAYS.
Patient problems: Thrombosis
MAUDE report 5804280 ↗InjuryJul 19, 2016Insufficient Device Problem Information
ON 06/24/2016 - PER SALES REPRESENTATIVE USER FACILITY REPORTED THAT THEY ARE SEEING AN INCREASE IN PATIENTS WITH PICCS REQUIRING TREATMENT FOR UPPER EXTREMITY VTE. THE FACILITY STATED THAT THEY ARE CONCERNED THAT THE REVERSE TAPER AND 7CM INTRODUCER ASSOCIATED WITH THE KIT IS CONTRIBUTING. THIS CATHETER WAS IN THE PATIENT FOR 71 DAYS.
Patient problems: Thromboembolism
MAUDE report 5804278 ↗InjuryJul 19, 2016Adverse Event Without Identified Device or Use Problem
ON 06/24/2016- PER SALES REPRESENTATIVE USER FACILITY REPORTED THAT THEY ARE SEEING AN INCREASE IN PATIENTS WITH PICCS REQUIRING TREATMENT FOR UPPER EXTREMITY VTE. THE FACILITY STATED THAT THEY ARE CONCERNED THAT THE REVERSE TAPER AND 7CM INTRODUCER ASSOCIATED WITH THE KIT IS CONTRIBUTING. THIS CATHETER WAS IN THE PATIENT FOR 36 DAYS.
Patient problems: Thromboembolism
MAUDE report 5804275 ↗InjuryJul 19, 2016Insufficient Device Problem Information
ON 06/24/2016 - PER SALES REPRESENTATIVE USER FACILITY REPORTED THAT THEY ARE SEEING AN INCREASE IN PATIENTS WITH PICCS REQUIRING TREATMENT FOR UPPER EXTREMITY VTE. THE FACILITY STATED THAT THEY ARE CONCERNED THAT THE REVERSE TAPER AND 7CM INTRODUCER ASSOCIATED WITH THE KIT IS CONTRIBUTING. THIS CATHETER WAS IN THE PATIENT FOR 67 DAYS.
Patient problems: Thrombosis
MAUDE report 5804231 ↗InjuryJul 19, 2016Insufficient Device Problem Information
ON 06/24/2016- PER SALES REPRESENTATIVE USER FACILITY REPORTED THAT THEY ARE SEEING AN INCREASE IN PATIENTS WITH PICCS REQUIRING TREATMENT FOR UPPER EXTREMITY VTE. THE FACILITY STATED THAT THEY ARE CONCERNED THAT THE REVERSE TAPER AND 7CM INTRODUCER ASSOCIATED WITH THE KIT IS CONTRIBUTING. THIS CATHETER WAS IN THE PATIENT FOR 4 DAYS.
Patient problems: Thromboembolism
MAUDE report 5804161 ↗InjuryJul 19, 2016Insufficient Device Problem Information
ON 06/24/2016- PER SALES REPRESENTATIVE USER FACILITY REPORTED THAT THEY ARE SEEING AN INCREASE IN PATIENTS WITH PICCS REQUIRING TREATMENT FOR UPPER EXTREMITY VTE. THE FACILITY STATED THAT THEY ARE CONCERNED THAT THE REVERSE TAPER AND 7CM INTRODUCER ASSOCIATED WITH THE KIT IS CONTRIBUTING. THIS CATHETER WAS IN THE PATIENT FOR 89 DAYS.
Patient problems: Thrombosis
MAUDE report 5804039 ↗
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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