PowerPICC Catheter 3275118Recalls & reported problems
Bard Access Systems, Inc. · PowerPICC Catheter 5F Nurse Basic Tray with Microintroducer (Dual-Lumen) · Class 2 · Implant
Quick summary
This Bard PowerPICC catheter appears in 266 adverse event reports, with no deaths and 23 injuries. The reports mostly describe fluid leaks, deformed or frayed material, contamination and breaks, along with some reports of blood clots, swelling and redness at the insertion site. No recalls name this device.
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
- 272
- Deaths reported
- 0
- Injuries reported
- 22
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 272 adverse event reports that list this exact device (DI 00801741027918), received between Jun 10, 2016 and Sep 10, 2026 — classified as 22 injuries, 250 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (79 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak79
- Material Deformation46
- Contamination /Decontamination Problem25
- Material Frayed25
- Defective Component19
- Break14
- Corroded12
- Adverse Event Without Identified Device or Use Problem11
Patient problems
- No Clinical Signs, Symptoms or Conditions199
- No Known Impact Or Consequence To Patient25
- No Consequences Or Impact To Patient16
- Thrombosis/Thrombus11
- Pain9
- Swelling/ Edema8
- Foreign Body In Patient5
- Hemorrhage/Blood Loss/Bleeding3
Recent adverse event reports
The 25 most recent of 272 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 10, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50716232 ↗MalfunctionSep 10, 2026Fluid/Blood Leak
It was reported a fluid leak was discovered 1 cm below the red port of the Extension Tubing during intravenous infusion with the PowerPICC catheter. Following the leakage, the catheter was promptly replaced to continue treatment. However, as the patient was on the second day after a stem cell transplant and had compromised immunity, reinsertion of the catheter posed risks such as catheter-related injury, bleeding, and infection. The patient is currently hospitalized for observation. No further information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50714878 ↗MalfunctionSep 10, 2026Fluid/Blood Leak
It was reported a fluid leak was discovered 1 cm below the red port of the Extension Tubing during intravenous infusion with the PowerPICC catheter. Following the leakage, the catheter was promptly replaced to continue treatment. However, as the patient was on the second day after a stem cell transplant and had compromised immunity, reinsertion of the catheter posed risks such as catheter-related injury, bleeding, and infection. The patient is currently hospitalized for observation. No further information was provided.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50714876 ↗MalfunctionSep 10, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50714874 ↗MalfunctionSep 9, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50700874 ↗MalfunctionAug 31, 2026Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50533107 ↗MalfunctionAug 31, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50533105 ↗MalfunctionAug 26, 2026Contamination /Decontamination Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50452722 ↗MalfunctionAug 19, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50328787 ↗MalfunctionAug 3, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50116869 ↗MalfunctionJul 10, 2026Material Deformation
IT WAS REPORTED THAT AFTER DILATION, THERE WAS RESISTANCE WHEN INSERTING THE MICROINTRODUCER INTO THE BLOOD VESSEL; UPON INSPECTION, BURRS WERE FOUND AT THE DISTAL END OF THE SHEATH. NO FURTHER DETAILS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES BOTH DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25781934 ↗MalfunctionJul 8, 2026Material Deformation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25746737 ↗InjuryJul 8, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED AFTER THE CATHETER WAS INSERTED, THE PATIENT EXPERIENCED REDNESS AND SWELLING AT THE PUNCTURE SITE, SKIN REPAIR. AN ALLERGIC REACTION TO THE DRESSING WAS SUSPECTED. NO FURTHER DETAILS PROVIDED.
Patient problems: Erythema; Local Reaction; Swelling/ Edema
MAUDE report 25746736 ↗MalfunctionJul 1, 2026Fluid/Blood Leak
IT WAS REPORTED A POWERPICC CATHETER RUPTURED. PRODUCT IS STILL BEING USED ON THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25679124 ↗MalfunctionJun 9, 2026Contamination /Decontamination Problem
IT WAS REPORTED DURING THE CATHETERIZATION PROCESS, A NURSE DISCOVERED AN FOREIGN MATERIAL ON THE STYLET WHILE TRIMMING THE CATHETER. THE ISSUE WAS RESOLVED AFTER REPLACING THE PRODUCT. IT WAS REPORTED THIS OCCURRED WITH TWO DEVICES. THIS REPORT ADDRESSES BOTH DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25446088 ↗MalfunctionJun 9, 2026Material Deformation
IT WAS REPORTED DURING CATHETER PLACEMENT, THE PUNCTURE SHEATH WAS BLUNT, LEADING TO A SPLIT IN THE DELIVERY SHEATH; A NEW CATHETER SET WAS USED TO REINSERT THE CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25444366 ↗MalfunctionJun 5, 2026Material Deformation
IT WAS REPORTED DURING CATHETER PLACEMENT, THE PUNCTURE SHEATH WAS BLUNT, LEADING TO A SPLIT IN THE DELIVERY SHEATH; A NEW CATHETER SET WAS USED TO REINSERT THE CATHETER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25411058 ↗MalfunctionJun 2, 2026Material Deformation
IT WAS REPORTED THAT DURING CATHETER PLACEMENT, THE PUNCTURE SHEATH WAS BLUNT, LEADING TO A SPLIT IN THE DELIVERY SHEATH; A NEW CATHETER SET WAS USED TO REINSERT THE CATHETER. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25360137 ↗MalfunctionJun 1, 2026Material Deformation
IT WAS REPORTED THE SHEATH TORE DURING CATHETER INSERTION, PREVENTING SUCCESSFUL PUNCTURE. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25355433 ↗MalfunctionMay 26, 2026Material Deformation
IT WAS REPORTED THAT DURING USE, THE VASCULAR SHEATH HAS RUPTURED AND THE DEVICE IS UNUSABLE. NO FURTHER DETAILS AVAILABLE. IT WAS REPORTED THIS OCCURRED WITH 3 DEVICES. THIS REPORT ADDRESSES ALL THREE DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25293044 ↗MalfunctionMay 4, 2026Contamination /Decontamination Problem
IT WAS REPORTED WHITE SPOTS ON THE GUIDEWIRE, PREVENTING INSERTION INTO THE BLOOD VESSEL. NO FURTHER INFORMATION WAS PROVIDED. IT WAS REPORTED THIS OCCURRED WITH EIGHT DEVICES. THIS REPORT ADDRESSES ALL EIGHT DEVICES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25073364 ↗MalfunctionApr 28, 2026Material Frayed
IT WAS REPORTED THAT THE GUIDEWIRE INSIDE THE CATHETER IS EXTREMELY SOFT AND FRAYED. NO ADDITIONAL INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25019903 ↗MalfunctionApr 22, 2026Difficult or Delayed Separation
IT WAS REPORTED THE PUNCTURE BRIDGE COULD NOT BE FULLY TORN OPEN, PREVENTING THE CATHETER FROM DETACHING. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24952853 ↗MalfunctionApr 13, 2026Detachment of Device or Device Component
IT WAS REPORTED THE PATIENT UNDERWENT PICC PLACEMENT UNDER ULTRASOUND GUIDANCE ON (B)(6). AROUND 10:00 A.M. ON JANUARY 20, A NURSE DISCOVERED THAT THE PICC CONNECTOR HAD BECOME DISCONNECTED FROM THE CATHETER DURING A ROUTINE REPOSITIONING. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24865103 ↗MalfunctionApr 2, 2026Fluid/Blood Leak
IT WAS REPORTED FLUID LEAKAGE WAS OBSERVED AT THE PUNCTURE SITE WHILE THE CATHETER WAS IN PLACE. UPON REMOVAL AND EXAMINATION, FLUID LEAKAGE WAS FOUND APPROXIMATELY 15 CM FROM THE CATHETER TIP. THE CATHETER WAS REMOVED, REPLACED, AND REINSERTED. NO FURTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24765523 ↗
Other Catheter,intravascular,therapeutic,long-term greater than 30 days devices
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- PowerPICC Catheter 3174118Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall402 reports
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- 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
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.