PowerPICC SOLO CK000169CRecalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741128219), received between Jul 13, 2017 and Nov 30, 2018 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Crack1
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 30, 2018Break
IT WAS REPORTED THE TRIPLE LUMEN PICC WAS INSERTED 10-16-18 AT 3:52PM, WHITE LUMEN BROKE 10-17-18 AT 1AM. IT WAS STATED THIS BROKE WITHOUT ANY MANIPULATION TO PRODUCT. CATHETER WAS REMOVED AND REPLACED. ADDITIONAL INFORMATION REC'D VIA MEDWATCH STATED, "WHITE PORT ON TLC PICC BROKE APART WITHIN NINE (9) HOURS OF PLACEMENT."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8121367 ↗MalfunctionJul 13, 2017Crack
FACILITY REPORTED TO THE SALES REP THAT THE CATHETER HAD A BREAK NEAR THE VALVE. THE PATIENT HAD A 6FR TRIPLE LUMEN PICC PLACED ON (B)(6) 2017. THE IV TEAM WAS CALLED TO BEDSIDE FOR BLEEDING FROM THE PICC ON (B)(6) 2017. IT WAS STATED THAT THE BLEEDING WAS FROM A CRACK AT THE SOLO VALVE OF THE WHITE LUMEN. PICC WAS REMOVED ON (B)(6) 2017, IN INTERVENTIONAL RADIOLOGY. NO PATIENT INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6710230 ↗
Other Catheter,intravascular,therapeutic,long-term greater than 30 days devices
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- Groshong NXT ClearVue Catheter 7655405Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days2 deaths1,536 reports
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- 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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