PowerPICC SOLO CK000410Recalls & reported problems
Bard Access Systems, Inc. · Catheter Placement Kit · Class 2 · Implant
All models of PowerPICC SOLO (78)
Data updated Oct 18, 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 00801741096297), received between Feb 25, 2021 and Feb 25, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (2 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 18, 2026.
Most reported problems
Device problems
- Material Deformation2
- Device Dislodged or Dislocated1
- No Flow1
Patient problems
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 25, 2021Material Deformation
IT WAS REPORTED "OCCURRED 12/7, OUT 3 CM ON INSERTION, PATIENT PULLED IT OUT FURTHER AND IT KINKED. PLACED ON 11/17 REF CK000410A, THIS IS A 5 FRENCH TRIPLE LUMEN POWERPICC SOLO PROVENA PICC."
Patient problems: No Consequences Or Impact To Patient
MAUDE report 11379778 ↗MalfunctionFeb 25, 2021Material Deformation; Device Dislodged or Dislocated; Material Deformation; No Flow
IT WAS REPORTED "PICC PLACED (B)(6) 2020 1 CM EXTERNAL REF CK000410A, THIS IS A 5 FRENCH TRIPLE LUMEN POWERPICC SOLO PROVENA PICC LOT REEW4191. (B)(6) 2020 NO BLOOD RETURN AND COIL FOUND IN BRACHIAL AREA. RETHREADED IN IR ON THE 29TH AND NEXT XRAY ON (B)(6) 2021 SHOWED NO LOOP. NO PRODUCT AVAILABLE FOR RETURN."
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11379773 ↗
Other Catheter,intravascular,therapeutic,long-term greater than 30 days devices
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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 Catheter 3275118Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days272 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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