PowerPICC SOLO 3CGRecalls & reported problems across all models
Bard Access Systems, Inc. · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 48
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 0
We found 2 models of PowerPICC SOLO 3CG by Bard Access Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 48 adverse event reports in the FDA's MAUDE database, received between Jun 30, 2025 and Sep 22, 2026 — classified as 48 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (31 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported PowerPICC SOLO 3CG problems
Device problems
- Material Deformation31
- Fluid/Blood Leak8
- Product Quality Problem3
- Contamination /Decontamination Problem2
- Device Markings/Labelling Problem2
- Crack1
- Difficult or Delayed Separation1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions47
- Insufficient Information1
PowerPICC SOLO 3CG models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PowerPICC SOLO 3CG C1194118Catheter, intravascular, therapeutic, long-term greater than 30 days42 reports
- PowerPICC SOLO 3CG C1295118Catheter, intravascular, therapeutic, long-term greater than 30 days6 reports
Recent PowerPICC SOLO 3CG adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50862362 ↗MalfunctionSep 22, 2026Material Deformation
It was reported that catheter sheath cracked, discovered during pre-use inspection. No additional information provided.It was reported this occurred with 2 devices. This report addresses both devices.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50856445 ↗MalfunctionSep 15, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50780230 ↗MalfunctionSep 15, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50780220 ↗MalfunctionSep 10, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50713982 ↗MalfunctionSep 1, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50552978 ↗MalfunctionSep 1, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50543413 ↗MalfunctionSep 1, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50543392 ↗MalfunctionSep 1, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50543391 ↗MalfunctionSep 1, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50543390 ↗MalfunctionAug 26, 2026Material Deformation
It was reported that catheter sheath rupture. No further details provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50454707 ↗MalfunctionAug 5, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50142533 ↗MalfunctionJul 29, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50068964 ↗MalfunctionJul 14, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25820126 ↗MalfunctionJul 9, 2026Material Deformation
IT WAS REPORTED CATHETER SHEATH RUPTURE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25762550 ↗
Other Bard Access Systems, Inc. products
- Port Access Needle122 models · 3,744 reports · 3 recalls
- Groshong NXT ClearVue Catheter8 models · 3,266 reports
- PowerPort ClearVUE27 models · 1,993 reports · 15 recalls
- Site~Rite 8 Ultrasound System11 models · 1,965 reports
- PowerPort M.R.I., ChronoFlex22 models · 1,642 reports · 1 recall
- PowerPICC Provena116 models · 1,337 reports · 2 recalls
- PowerPort M.R.I., Groshong10 models · 1,285 reports
- Navarre15 models · 1,228 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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