PowerPICC Provena S3385335Recalls & reported problems
Bard Access Systems, Inc. · PPICC KR, 5F TL, IR, w/Nit 135cm GW · Class 2 · Implant
All models of PowerPICC Provena (116)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741112805), received between May 12, 2023 and May 12, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Deformation” (2 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.
Most reported problems
Device problems
- Material Deformation2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 12, 2023Material Deformation; Material Deformation
CUSTOMER REPORTED A 5FR TL POWERPICC PROVENA INSERTED IN THE RIGHT UPPER ARM BASILIC VEIN ON (B)(6) 2023 WAS FOUND TO BE KINKED ON (B)(6) 2023 IN THE UPPER 1/3 OF THE UPPER EXTREMITY. PICC DWELL TIME WAS 3 DAYS. PICC WAS REMOVED AND A CVC WAS PLACED BY IR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16924406 ↗MalfunctionMay 12, 2023Material Deformation; Material Deformation
CUSTOMER REPORTED A 5FR TL POWERPICC PROVENA INSERTED IN THE RIGHT UPPER ARM BASILIC VEIN ON (B)(6) 2023 WAS SUSPECTED TO BE KINKED DUE TO PERSISTENT SLUGGISHNESS AND INTERMITTENT BLOOD RETURN. PICC DWELL TIME WAS 0 DAYS. PICC REMOVED AND A TUNNELED CVC PLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16924402 ↗
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- 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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