Pro-PICC® CT MR17035101Recalls & reported problems
Medical Components, Inc. · 5F X 60CM SINGLE LUMEN Pro-PICC® CT BASIC IR SET · Class 2 · Implant
All models of Pro-PICC CT (12)
Data updated Oct 16, 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 00884908033168), received between Jul 30, 2019 and Jun 24, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (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 16, 2026.
Most reported problems
Device problems
- Leak/Splash2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 24, 2020Leak/Splash; Leak/Splash
CONNECTION LEAK. THE INSERTION SITE WAS THE RIGHT BASAL VEIN GUIDED BY ULTRASOUND. THE LEAK IN THE CONNECTION WAS VERIFIED DAYS AFTER INSERTION, NO CRACKS IN THE CATHETER WERE OBSERVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10189032 ↗MalfunctionJul 30, 2019Leak/Splash; Leak/Splash
LEAKAGE FROM A HOLE IN THE EXTENSION LINE WAS DETECTED IMMEDIATELY AFTER DEVICE WAS IMPLANTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8840712 ↗
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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® 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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