Pro-PICC® CT MR17035201Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00884908033250), received between Jul 1, 2019 and Aug 1, 2023 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionJul 1, 2019Fracture; Fracture

  CATHETER RUPTURED 2MM BEYOND THE 26CM MARK. REASON FOR PASSAGE OF THE PICC TO ANTIBIOTIC THERAPY (ROCEFIN)

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8748421 ↗