Pro-PICC® CT MR17035102Recalls & reported problems
Medical Components, Inc. · 5F X 60CM SINGLE LUMEN Pro-PICC® CT BASIC LONG WIRE 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 00884908033175), received between Sep 13, 2017 and May 20, 2022 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Entrapment of Device” (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
- Entrapment of Device1
- Leak/Splash1
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 20, 2022Entrapment of Device; Material Twisted/Bent; Entrapment of Device; Material Twisted/Bent
GUIDEWIRE COILED/KNOTTED WHEN ADVANCED TO AUXILIARY VEIN. DIFFICULT TO REMOVE WIRE, WOULD NOT UNRAVEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14454605 ↗MalfunctionSep 13, 2017Leak/Splash; Leak/Splash
PATIENT FELT PRESSURE IN THE UPPER ARM AND HAD THE IMPRESSION OF SWELLING DURING PREMEDICATION WHICH WAS STOPPED IMMEDIATELY. PICC HAS BEEN CHECKED UNDER RIS WITH INJECTION OF CONTRAST AND A CRACK HAS BEEN SEEN AT THE HEIGHT OF SUBCLAVIA. NEW PICC WAS IMPLANTED. NO FURTHER EVENT OCCURRED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6861163 ↗
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® 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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