PowerPICC SOLO2 Catheter 3295118Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741028090), received between Mar 18, 2016 and Oct 16, 2018 — classified as 1 injury, 6 malfunctions.

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

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 16, 2018Infusion or Flow Problem

  THE FOLLOWING WAS REPORTED VIA AN EMAIL SENT TO VAD SALES REP: "INABILITY TO ASPIRATE BLOOD WITH PICC INSERTION DESPITE PICC AT THE CAVOATRIAL JUNCTION (MANY REPOSITIONING ¿ MECHANICALLY IRRITATING THE VESSEL WALL). LAST WEEK A COWORKER PLACED A PICC, NO BLOOD RETURN, IN GOOD POSITION; THAT PATIENT WENT TO IR FOR PICC IN OTHER ARM. LINE WAS EXCHANGED IN IR, CURRENTLY LOOKING FOR REPORT".

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7972076 ↗
• MalfunctionJun 6, 2018Break

  IT WAS REPORTED THAT WHEN INFUSION THERAPY WAS GIVEN ON THE SAME DAY, THE NURSE FOUND THAT THE THERE WAS SEVERE FRACTURE AT THE INTERSECTION OF THE BIFURCATION AND THE EXTENSION TUBE, AND THE CATHETER WAS REMOVED. THE CATHETER WAS BROKEN DURING THE REMOVAL OF THE CATHETER.

  Patient problems: No Code Available

  MAUDE report 7574089 ↗
• MalfunctionOct 25, 2017No Flow

  IT WAS REPORTED THAT PICC WAS INSERTED (B)(6) 2017, RED LUMEN ALLEGEDLY UNABLE TO FLUSH OR GET BLOOD DRAW BACK. STAFF NEEDING TO ADMINISTER ALTEPLASE TO LUMEN 2-3 TIMES PER WEEK. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6976162 ↗
• MalfunctionDec 1, 2016Fluid/Blood Leak

  IT WAS REPORTED ON (B)(6) 2016 BY THE HEALTHCARE PROFESSIONAL, THAT LEAKAGE AND SWELLING TO THE PATIENT'S ARM HAD OCCURRED AS WELL AS DISCOMFORT AT THE INSERTION SITE. IT WAS REPORTED THAT THERE MAY BE DAMAGE TO THE PICC.

  Patient problems: Discomfort; Swelling

  MAUDE report 6139747 ↗
• MalfunctionJul 1, 2016Leak/Splash

  IT WAS REPORTED THAT UNIT NOTED LEAKING FROM PICC AND ASSESSED ALLEGED DAMAGE BEFORE 0 CM MARK AND AT 7 CM MARK. PICC HAD BEEN INSITU X 30 DAYS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5765057 ↗
• InjuryJun 1, 2016Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING PICC INSERTION, A PATIENT ALLEGEDLY EXPERIENCED FACIAL FLUSHING LASTING APPROXIMATELY 30 SECONDS, DIFFICULTY TAKING A FULL BREATH, STOMACH WARMTH, AND ABDOMINAL DISCOMFORT. ENTIRE REACTION RESOLVED IN APPROXIMATELY 5 MINUTES. OXYGEN WAS APPLIED DURING REACTION AND VITAL SIGNS WERE STABLE THROUGHOUT REACTION. PATIENT STATED THAT SHE "FELT COMPLETELY NORMAL" AFTER APPROXIMATELY 5 MINUTES. PICC WAS LEFT IN SITU IN PATIENT.

  Patient problems: Discomfort; Dyspnea; Reaction

  MAUDE report 5693190 ↗
• MalfunctionMar 18, 2016Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2016 - BAS ENGINEERS FOUND THAT THE SAMPLE RETURNED FOR A SEPARATE COMPLAINT HAD A FIBRIN SHEATH ON THE SUBCUTANEOUS SECTION OF THE CATHETER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5510427 ↗