PowerPICC® SV Catheter 3274335Recalls & reported problems
Bard Access Systems, Inc. · PPICC SV 4Fr DL IR w/Nit · Class 2 · Implant
All models of PowerPICC SV Catheter (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741027857), received between Jun 24, 2024 and May 18, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (6 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
- Fluid/Blood Leak6
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Discomfort1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 18, 2026Fluid/Blood Leak
IT WAS REPORTED THAT DURING HOME VISIT FOR PICC CARE. PICC WHITE LUMEN CRACKED AND LEAKING. SENT TO ER TO BE REWIRED. NO APPARENT HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25205255 ↗MalfunctionMay 11, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THEY ENCOUNTERED A CRACK AT THE HUB ON ONLY ONE LUMEN. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25136710 ↗MalfunctionJul 8, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED BY CUSTOMER THAT WHEN ATTEMPTING TO FLUSH RED LUMEN, LEAKAGE NOTED AT THE INTERSECTION WHERE THE RED CAP MEETS THE LINE - AT THE MOST DISTAL SECTION OF THE LUMEN. NO HARM TO THE PATIENT. NO FURTHER INFORMATION PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22448064 ↗MalfunctionApr 22, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THE PICC LINE HAD FRACTURES. RESULTED IN UNEXPECTED OR PROLONGED CARE FOR ONE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21882911 ↗MalfunctionJan 9, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED PICC FRACTURED AND LEAKING. LENGTH WAS 48CM, EXIT SITE MARKING 2CM, LEAKING AT 1CM. SECURED WITH A SECUREACATH. UNABLE TO REINSERT PICC AT BEDSIDE; REFERRED TO IR FOR INSERTION OF TUNNELED SMALL-BORE CVC ON (B)(6) 2023.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21120435 ↗MalfunctionJun 24, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT SHORTLY AFTER SHIFT CHANGE THE DRESSING WAS SATURATED IN IV FLUID. THE ICU FELLOW NOTIFIED AND WHEN ATTEMPTING TO ASPIRATE THE LINE THERE WAS A LOT OF AIR COMING OUT. IT WAS DECIDED TO REMOVED THE LINE. THE PICC LINE WAS ALSO NOTED TO HAVE GONE INTERSTITIAL. INCONVENIENT FOR PATIENT, NO PATIENT HARM. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: Discomfort
MAUDE report 19595366 ↗
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- 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 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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