PowerPICC® HF Catheter 3385108QDRecalls & reported problems
Bard Access Systems, Inc. · DOT STC PPICC Max, 5Fr · Class 2 · Implant
All models of PowerPICC HF Catheter (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741028175), received between Aug 8, 2016 and Jan 10, 2019 — classified as 2 injuries.
The most frequently reported specific device problem is “Material Fragmentation” (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 18, 2026.
Most reported problems
Device problems
- Material Fragmentation1
- Migration or Expulsion of Device1
Patient problems
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 10, 2019Material Fragmentation
IT WAS REPORTED THAT AFTER PLACEMENT, IT WAS OBSERVED THAT WHAT APPEARS TO BE A "REMANENCE" OF A GUIDEWIRE WAS LEFT IN PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 8237019 ↗InjuryAug 8, 2016Migration or Expulsion of Device
ON (B)(6) 2016 PER SALES REPRESENTATIVE, FACILITY CONTACT REPORTED THAT THEY FOUND A PIECE OF THE MICRO INTRODUCER WIRE STILL IN THE PATIENT. THIS WAS NOTICED WHEN THE PATIENT WAS ADMITTED. A SMALL PIECE OF THE WIRE WAS NOTICED IN THE PATIENT'S CHEST X-RAY, SINCE PICC WAS PLACED. THE WIRE MIGRATED TO THE PATIENT'S HEART AND THE PATIENT WAS SENT TO IR FOR RETRIEVAL BUT WIRE COULD NOT BE RETRIEVED.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 5855219 ↗
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 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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