NA P1PIC1.9-SRecalls & reported problems
Footprint Medical, Inc. · 1.9Fr Single Lumen Polyurethane PIC Catheter Kit · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00858778006089), received between Jan 11, 2018 and Jan 16, 2020 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Leak/Splash” (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 16, 2026.
Most reported problems
Device problems
- Leak/Splash1
- Material Fragmentation1
Patient problems
- Injury1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 16, 2020Material Fragmentation; Material Fragmentation
THE PICC LINE BROKE DURING ATTEMPTED EXTRACTION. THE BROKEN PORTION OF THE CATHETER WAS SURGICALLY REMOVED. PATIENT IS DOING WELL.
Patient problems: Injury
MAUDE report 9598297 ↗MalfunctionJan 11, 2018Leak/Splash; Leak/Splash
A LEAK WAS DISCOVERED IN THE PICC CATHETER DURING A PICC DRESSING CHANGE. THERE WAS A SMALL HOLE IN THE CATHETER IN THE EXTERNAL PORTION NEAR THE HUB. THE PHYSICIAN WAS NOTIFIED AND THE PICC WAS DISCONTINUED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7184188 ↗
Other Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days devices
- Groshong NXT ClearVue Catheter 7617405Bard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days2 deaths1,708 reports
- 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® Catheters 1174108DBard Access Systems, Inc. · Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall222 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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