PowerPICC SOLO 3CG C1194118Recalls & reported problems
Bard Access Systems, Inc. · PowerPICC SOLO 4F SL w/CG (55 cm) · Class 2 · Implant
All models of PowerPICC SOLO 3CG (2)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Bard PowerPICC SOLO 4F catheter is a long-term implanted central line for IV access. The 34 reports mostly describe the catheter sheath deforming or splitting, sometimes rupturing and leaking fluid or blood. No deaths and no injuries were reported. There are no recalls naming this device. Reports rose from 4 in the prior 12 months to 30 in the last 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 42
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 00801741218149), received between Jun 30, 2025 and Sep 22, 2026 — classified as 42 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (30 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.
Reports received per month
Most reported problems
Device problems
- Material Deformation30
- Fluid/Blood Leak8
- Contamination /Decontamination Problem1
- Crack1
- Device Markings/Labelling Problem1
- Difficult or Delayed Separation1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions41
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 42 reports, 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 ↗MalfunctionJun 4, 2026Material Deformation
05/22/2026- IT WAS FOUND DURING AN INVESTIGATION ALL THREE SAMPLES EXHIBITED A LONGITUDINALLY ALIGNED SPLIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25403144 ↗MalfunctionApr 7, 2026Material Deformation
IT WAS REPORTED THAT CATHETER SHEATH RUPTURE. NO FURTHER DETAILS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24800638 ↗MalfunctionApr 3, 2026Material Deformation
IT WAS REPORTED THAT CATHETER SHEATH RUPTURE. NO FURTHER DETAILS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24774743 ↗MalfunctionApr 1, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THE PATIENT DISCOVERED A CRACK IN THE CATHETER AT THE 12 CM MARK AFTER USING IT FOR NEARLY THREE MONTHS. THE LEAK WAS DISCOVERED BY A NURSE DURING ROUTINE MAINTENANCE WHILE THE PATIENT WAS READMITTED TO THE HOSPITAL AFTER USING THE DEVICE FOR MORE THAN TWO MONTHS. THE PATIENT HAD NO SUBJECTIVE SYMPTOMS; AFTER THE LEAK WAS DISCOVERED, THE CATHETER WAS REMOVED AND A NEW ONE WAS INSERTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24757919 ↗MalfunctionApr 1, 2026Material Deformation
IT WAS REPORTED CATHETER SHEATH RUPTURE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24753008 ↗MalfunctionMar 30, 2026Material Deformation
IT WAS REPORTED CATHETER SHEATH RUPTURE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24732805 ↗MalfunctionMar 26, 2026Material Deformation
IT WAS REPORTED, CATHETER SHEATH RUPTURE. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24705800 ↗MalfunctionMar 25, 2026Material Deformation
IT WAS REPORTED, INTRODUCER SHEATH CRACKING ISSUE WITH EIGHT UNITS. THIS REPORT ADDRESSES ALL EIGHT DEVICES. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24688562 ↗MalfunctionMar 24, 2026Material Deformation
IT WAS REPORTED CATHETER SHEATH CRACK. NO FURTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH THREE DEVICES. THIS REPORT ADDRESSES ALL THREE DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24682781 ↗MalfunctionMar 24, 2026Device Markings/Labelling Problem
IT WAS REPORTED THAT PRINT SCALES DISAPPEAR AFTER WIPING WITH DISINFECTANT (NOT ALCOHOL). RECENTLY HOSPITAL HAS EXPERIENCED FREQUENT INSTANCES OF DISAPPEARING CATHETER GRADUATIONS DURING MAINTENANCE OF MAGNETIC NAVIGATION CATHETERS. THIS CASE INVOLVES A SINGLE-LUMEN CATHETER. THE DISINFECTANTS USED CLINICALLY ARE POVIDONE-IODINE AND CHLORHEXIDINE. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24682430 ↗
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 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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