Pro-PICC CTRecalls & reported problems across all models
Medical Components, Inc. · 12 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 31
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 0
We found 12 models of Pro-PICC CT by Medical Components, Inc. in the FDA's device registry (GUDID). Together they are named in 31 adverse event reports in the FDA's MAUDE database, received between Jun 13, 2017 and Dec 13, 2024 — classified as 3 injuries, 28 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (17 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Pro-PICC CT problems
Device problems
- Leak/Splash17
- Break8
- Fracture2
- Appropriate Device Problem Term/Code Not Available1
- Difficult to Remove1
- Entrapment of Device1
- Hole In Material1
- Knotted1
Patient problems
- No Known Impact Or Consequence To Patient12
- No Clinical Signs, Symptoms or Conditions10
- Pain4
- Extravasation2
- Foreign Body In Patient1
- Injury1
- Insufficient Information1
- No Information1
Pro-PICC CT models
12 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Pro-PICC® CT MR17034101Catheter,intravascular,therapeutic,long-term greater than 30 days6 reports
- Pro-PICC® CT MR17035201Catheter,intravascular,therapeutic,long-term greater than 30 days6 reports
- Pro-PICC® CT MR17034102Catheter,intravascular,therapeutic,long-term greater than 30 days4 reports
- Pro-PICC® CT MR82036301Catheter,intravascular,therapeutic,long-term greater than 30 days3 reports
- Pro-PICC® CT MR17035101Catheter,intravascular,therapeutic,long-term greater than 30 days2 reports
- Pro-PICC® CT MR17035102Catheter,intravascular,therapeutic,long-term greater than 30 days2 reports
- Pro-PICC® CT MR17036302Catheter,intravascular,therapeutic,long-term greater than 30 days2 reports
- Pro-PICC® CT MR17036306MBCatheter,intravascular,therapeutic,long-term greater than 30 days2 reports
- Pro-PICC® CT MR17034105Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- Pro-PICC® CT MR17035206MBCatheter,intravascular,therapeutic,long-term greater than 30 days1 report
- Pro-PICC® CT MR17033105Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- PRO-PICC® CT MRCTP41028Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
Recent Pro-PICC CT adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionDec 13, 2024Break; Break
BASILIC VEIN PUNCTURED USING INTRODUCER NEEDLE UNDER U/S GUIDANCE-GOOD BLOOD FLOW THROUGH NEEDLE. ATTEMPTED TO PASS GUIDEWIRE VIA NEEDLE, BUT EXPERIENCED RESISTANCE. UNABLE TO WITHDRAW GUIDEWIRE. FLUOROSCOPY OF PATIENT'S ARM-TIP OF GUIDEWIRE APPEARED KNOTTED. ATTEMPTS TO MANIPULATE WIRE UNDER FLUOROSCOPIC GUIDANCE UNSUCCESSFUL. ATTEMPTS TO UNTANGLE KNOW USING 4F DILATOR UNSUCCESSFUL. THE PATIENT HAD TO GO TO THEATRE.
Patient problems: Foreign Body In Patient
MAUDE report 20923799 ↗MalfunctionMay 8, 2024Leak/Splash; Leak/Splash
EXTRAVASATION OF SOLUTION THROUGH THE OSTIUM. THE PATIENT WAS PUNCTURED ON (B)(6) 2024. ON (B)(6) 2024, EXTRAVASATION WAS NOTICED DUE TO MOISTURE IN THE DRESSING. ON (B)(6) 2024, THE INSERTION NURSE ASSESSED AND REMOVED THE CATHETER. THERE WAS NO NEED FOR A NEW PUNCTURE. PATIENT WAS DISCHARGED HOME.
Patient problems: Extravasation
MAUDE report 19269183 ↗MalfunctionMay 8, 2024Leak/Splash; Leak/Splash
EXTRAVASATION OF SOLUTION THROUGH THE OSTIUM. ON (B)(6) 2024 THE PROCEDURE WAS CARRIED OUT. THE OCCURRENCE WAS NOTICED ON THE SAME NIGHT OF INSERTION, THROUGH THE NEED FOR NUMEROUS DRESSING CHANGES DUE TO HUMIDITY. ON (B)(6) 2024, THE CATHETER WAS EVALUATED BY THE INSERTION TEAM AND HAD TO BE REMOVED. NEW ACCESS WAS PERFORMED
Patient problems: Extravasation
MAUDE report 19269098 ↗MalfunctionAug 1, 2023Leak/Splash; Leak/Splash
A LEAKING FROM THE CATHETER HUB WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17439074 ↗MalfunctionJan 17, 2023Break; Break
BREAKAGE OF THE BI-DIRECTIONAL VALVE ON THE YELLOW TRACT WHICH SEPARATED INTO TWO PIECES DURING POST-SAMPLING IRRIGATION WITH 10 ML SYRINGE OF 0.9% NACL AFTER CHANGING NEEDLE-LESS CONNECTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16185477 ↗MalfunctionJan 17, 2023Break; Break
BREAKAGE OF THE BI-DIRECTIONAL VALVE ON THE YELLOW TRACT WHICH SEPARATED INTO TWO PIECES DURING POST-SAMPLING IRRIGATION WITH 10 ML SYRINGE OF 0.9% NACL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16185330 ↗MalfunctionJan 4, 2023Break; Break
BREAKAGE OF THE BI-DIRECTIONAL VALVE ON THE YELLOW TRACT WHICH SEPARATED INTO TWO PIECES DURING POST-SAMPLING IRRIGATION WITH 10 ML SYRINGE OF 0.9% NACL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16093719 ↗MalfunctionJan 3, 2023Leak/Splash; Leak/Splash
PATIENT SENT TO PICC TEAM BECAUSE DEVICE DID NOT ASPIRATE AND PATIENT EXPLAINED INFUSION PAIN ASSOCIATED WITH ARM EDEMA. UPON OBSERVATION THE PICC DOES NOT ASPIRATE AND INFUSES WITH RESISTANCE. ULTRASOUND SHOWS COMPRESSIBLE VEIN SO DEVICE WAS REMOVED. AFTER REMOVAL A KINK AND CRACK WAS FOUND ABOUT 10CM FROM THE EXIT SITE.
Patient problems: Pain
MAUDE report 16086326 ↗MalfunctionOct 31, 2022Break; Break
IMPLANTATION OF A PICC CATHETER WAS PERFORMED. AFTER INTRODUCING THE PICC, AN ATTEMPT WAS MADE TO REMOVE THE GUIDE WIRE WITH A LOT OF RESISTANCE. WHEN REMOVING THE GUIDE WIRE, A FRACTURE WAS IDENTIFIED WITH EXTRAVASATION OF SERUM IN THE CATHETER BODY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15698941 ↗InjurySep 2, 2022Break; Break
ATTEMPTED AT PUNCTURE OF PICC PERFORMED ACCORDING TO MEDICAL REQUEST. VENOUS NETWORK EVALUATED WITH USG AID AND LEFT BASIC VEIN SELECTED FOR PUNCTURE. STARTED THE GUIDED PROCEDURE WITH USG. NEEDLE PUNCTURE PERFORMED AND AFTER VENOUS RETURN INSERTED APPROXIMATELY 4 CM FROM THE GUIDE WIRE AND THERE WAS RESISTANCE, OPTED FOR THE REMOVAL OF THE GUIDE WIRE TO REPOSITION THE NEEDLE, BUT WHEN ATTEMPTING TO REMOVE THE GUIDE WIRE, IT DID NOT COME OUT, NEEDLE PULLED OUT AND REMOVED BUT THE GUIDE WIRE IS NOT, YET IT WENT OUT. MEDICAL COMMUNICATION WHO EVALUATED AND WAS NOT ABLE TO REMOVE THE GUIDE WIRE EVEN AFTER PERFORMING A PIC ON THE SKIN. I ALSO INFORM THAT THE SITE HAS NO ACTIVE BLEEDING, SHOWING THAT THE GUIDE WIRE POSSIBLE WAS IN THE SUBCUTANEOUS TISSUE. AFTER PERFORMING X-RAY, IT SHOWED A FOLD IN THE TIP OF THE GUIDE WIRE. VASCULAR PHYSICIAN PERFORMS REMOVAL BY TRACTION AND AFTER A NEW X-RAY, THE PRESENCE OF A REMAINING FRAGMENT IN THE SUBCUTANEOUS TISSUE WAS EVIDENCED. PATIENT WILL BE SUBMITTED TO DISSECTION FOR FRAGMENT REMOVAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15348186 ↗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 ↗MalfunctionJul 22, 2021Leak/Splash; Leak/Splash
CATHETER INSERTED ON (B)(6) 2021, SHOWED EXTERNALIZATION OF APPROXIMATELY 4CM AND RUPTURE WITH MEDICATION OVERFLOW ON (B)(6) 2021, EVIDENCED DURING DRESSING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12210242 ↗MalfunctionJul 1, 2021Leak/Splash; Leak/Splash
CATHETER IS LEAKING AND MACERATED AFTER DAYS OF INSERTION.
Patient problems: Insufficient Information
MAUDE report 12098950 ↗MalfunctionMar 24, 2021Leak/Splash; Leak/Splash
TWO DAYS AFTER INSERTION DURING FIRST INFUSION SESSION A LEAK WAS NOTED IN THE EXTENSION LINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11562461 ↗MalfunctionJan 18, 2021Break; Break
NEXT DAY AFTER INSERTION IT WAS NOT POSSIBLE TO ASPIRATE OR FLUSH THE PICC. BY CONTRAST MEDIUM ADMINISTRATION IN RADIOLOGY IT WAS SEEN THAT THE PICC WAS SEPARATED IN THE BODY. THE PICC WAS REMOVED TRANSFEMORALLY AND VIA THE BASAL VEIN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11188646 ↗
Other Medical Components, Inc. products
All Medical Components, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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