PowerPICC SOLO2 Catheter 1396108DRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00801741034749), received between May 23, 2017 and Nov 21, 2018 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Crack” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryNov 21, 2018Defective Device

  IT WAS REPORTED THAT THE FACILITY HAD AN ECG VERIFIED PICC THAT TURNED OUT TO BE ARTERIAL. IT WAS STATED THE PICC WAS PLACED BY SEASONED PICC NURSE WHO IS VERY METICULOUS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8096606 ↗
• MalfunctionNov 1, 2018Leak/Splash

  IT WAS REPORTED BY A RN AT THE HOSPITAL THAT THE PICC WAS PLACED ON (B)(6)2018. IT WAS STATED THAT THE PICC WASFULLY FUNCTIONAL WITHOUT PROBLEMS. THE RN WAS CALLED TO ASSESS THIS SAME PICC ON (B)(6)2018. IT WAS NOTED THAT IT WAS LEAKING WHEN THE WHITE LUMEN WAS FLUSHED. THE PICC WAS EXCHANGED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8028465 ↗
• InjuryAug 30, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT DEVELOPED DVT SIX DAYS AFTER INSERTION.

  Patient problems: Thrombosis

  MAUDE report 7832742 ↗
• InjuryAug 30, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED A DVT FIVE DAYS AFTER INSERTION.

  Patient problems: Thrombosis

  MAUDE report 7832686 ↗
• MalfunctionNov 21, 2017Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PICC LINE BEGAN TO LEAK FROM THE HUB. IT WAS NOTED THAT THE HUB WAS CRACKED. THE PICC WAS REMOVED AND REPLACED. NO REPORTED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7050376 ↗
• MalfunctionOct 27, 2017Crack

  FACILITY REPORTED TO THE SALES REP THAT DURING PLACEMENT THE HEALTHCARE PROFESSIONAL NOTICED A CRACK ON THE HUB OF THE WHITE PORT. A NEW DEVICE WAS OPENED TO COMPLETE THE PROCEDURE. NO INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6985172 ↗
• MalfunctionAug 24, 2017Crack

  FACILITY REPORTED TO THE SALES REP THAT AFTER PLACEMENT, WHILE FLUSHING THE HEALTHCARE PROFESSIONAL NOTED A CRACKED HUB. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6817245 ↗
• MalfunctionAug 17, 2017Crack

  SALES REP REPORTED THAT THERE IS AN ALLEGED CRACK IN THE HUB OF 6 FR TRIPLE LUMEN CATHETER. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6802489 ↗
• MalfunctionJul 7, 2017Break; Crack; Material Disintegration

  IT WAS REPORTED BY THE FACILITY THAT THEY HAD A CRACKED VALVE. UPDATE 06/14/17 - ADDITIONAL INFORMATION RECEIVED FROM FACILITY: THEY REPORTED THAT THE WHITE LUMEN ON THE TRIPLE LUMEN POWER PICC BROKE AND DISINTEGRATED AT THE VALVE SITE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6692566 ↗
• MalfunctionMay 23, 2017Crack

  IT WAS REPORTED BY THE FACILITY THAT THE VALVE ON THE PICC LINE CRACKED. NO OTHER INFORMATION WAS PROVIDED. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6584773 ↗