PowerPICC SOLO2 Catheter 3194135Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741027758), received between Apr 23, 2018 and Sep 29, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Mar 11, 2025Class IOpen, Classified

   Catheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt flow index specification (higher), which could lead to increased material fatigue leaks, which could lead to infiltration, extravasation, discomfort, phlebitis, bleeding, air embolism, foreign body embolism, infection and interruption to therapy.

   Z-1507-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2021Material Discolored; Material Discolored

  IT WAS REPORTED VIA MS&S "WHAT COULD CAUSE THE POWERPICC LINE TO TURN BLACK? HAVE YOU HEARD OF A PICC LINE DOING THIS WITH AN ARSENIC TRIOXIDE INFUSION? POWERPICC LINE PLACED 6 MONTHS AGO. PATIENT RECEIVING ARSENIC TRIOXIDE THROUGH POWERPICC LINE. POWERPICC LINE TURNING BLACK FROM HUB TO WINGS. PATIENT ARRIVED AT THE FACILITY 1 MONTH AGO WITH DISCOLORED(BLACK) PICC. NURSE STATED THEY SPOKE WITH OTHER ONCOLOGY NURSES WHO HAVE INFUSED ARSENIC TRIOXIDE WITH POWER PICCS IN THE PAST WITH NO ISSUES. THE PHARMACIST ALSO CONTACTED THE DRUG MANUFACTURER AND STATED THERE ARE NO CONTRAINDICATIONS. PATIENT SCHEDULED TO HAVE POWERPICC EXCHANGED. FACILITY REQUESTING A PRODUCT RETURN KIT AS SOON AS POSSIBLE. NURSE STATES SHE WILL CHECK THE CHART FOR A REF # AND LOT# AND CALL BACK." ADDITIONAL INFO. RECEIVED 07/13/2021: WHAT TYPE OF CATHETER SECUREMENT WAS UTILIZED? DURING HER STAY AT FACILITY, WE UTILIZED STATLOCK. PATIENT ADMITTED (B)(6) 2021. DATE OF OCCURRENCE: FIRST DOCUMENTED (B)(6) 2021. PATIENT STATES IT WAS THIS COLOR FOR ¿MANY MONTHS¿. STAFF ALL THOUGHT IT WAS SUPPOSED TO LOOK THAT WAY UNTIL SEEN BY MYSELF ON (B)(6) 2021. WHAT THEY'RE BEING TREATED FOR: ACUTE PROMYELOCYTIC LEUKEMIA. CONC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12550883 ↗
• MalfunctionAug 25, 2021Failure to Infuse; Failure to Infuse

  IT WAS REPORTED "PATIENT RECEIVED 3 DOSES OF ALTEPLASE DURING HER STAY." MS&S RESPONSE "RESPONSE INFORMED WE DO NOT HAVE ANY TESTING WITH ARSENIC TRIOXIDE IN POWERPICC LINES. SUGGESTED SHE CONTACT THE DRUG MANUFACTURER FOR INFUSION RECOMMENDATIONS AND CATHETER COMPATIBILITY. WE RECOMMEND THE PICC LINE BE REPLACED WITH A NEW LINE THAT IS COMPATIBLE WITH THE DRUG MANUFACTURE GUIDELINES."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12368772 ↗
• MalfunctionApr 23, 2018Break

  IT WAS REPORTED THAT ON (B)(6) 2018 THE PATIENT EXPERIENCED A BROKEN PICC LINE. THE PICC WAS INSERTED ON (B)(6) 2018. THERE WAS NO REPORTED PATIENT INJURY. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7450640 ↗