PowerPICC Provena S3173108DRecalls & reported problems
Bard Access Systems, Inc. · 3 Fr Single 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741130380), received between Mar 29, 2018 and Apr 19, 2018 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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
- Fluid/Blood Leak3
Patient problems
- No Known Impact Or Consequence To Patient2
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 19, 2018Fluid/Blood Leak
THE FACILITY REPORTED TO THE SALES REP THAT A PROVENA CATHETER LEAKED FROM THE EXTENSION LEG. IT WAS STATED THAT THERE WAS NO HARM TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7445487 ↗MalfunctionMar 29, 2018Fluid/Blood Leak
THE FACILITY REPORTED TO THE SALES REP THAT TWO PROVENA CATHETERS LEAKED INFUSATE AND BLOOD FROM THE EXTENSION LEG. IT WAS STATED THAT THERE WAS NO HARM TO THE PATIENT. THIS FILE ADDRESSES THE FIRST OF THE TWO DEVICES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7383670 ↗MalfunctionMar 29, 2018Fluid/Blood Leak
THE FACILITY REPORTED TO THE SALES REP THAT TWO PROVENA CATHETERS LEAKED INFUSATE AND BLOOD FROM THE EXTENSION LEG. IT WAS STATED THAT THERE WAS NO HARM TO THE PATIENT.THIS FILE ADDRESSES THE SECOND OF THE TWO DEVICES.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7383667 ↗
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
- PowerPICC Catheter 3174118Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall402 reports
- 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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