PowerPICC Provena S9274118Recalls & reported problems
Bard Access Systems, Inc. · 4 Fr Dual Lumen · Class 2 · Implant
All models of PowerPICC Provena (116)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741130328), received between Jan 25, 2018 and Apr 18, 2018 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Fluid/Blood Leak1
- Leak/Splash1
- Nonstandard Device1
Patient problems
- No Known Impact Or Consequence To Patient2
- No Code Available1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 18, 2018Leak/Splash
IT WAS REPORTED THAT THE PROVENA LEAKED AT THE HUB. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7441894 ↗MalfunctionApr 18, 2018Fluid/Blood Leak; Nonstandard Device
IT WAS REPORTED THAT THE PROVENA LEAKED AT THE HUB. THERE WAS NO REPORTED PATIENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7441889 ↗InjuryJan 25, 2018Break
IT WAS REPORTED BY THE SALES REP THAT THE FACILITY HAD A STYLET THAT THE MAGNETIC PORTION OF THE TIP BROKE OFF IN THE PATIENT, IT WAS SNARED OUT.
Patient problems: No Code Available
MAUDE report 7220656 ↗
Other Catheter,intravascular,therapeutic,long-term greater than 30 days devices
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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
- 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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