PowerPICC SOLO2 Catheter 3295108DRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00801741028052), received between Feb 15, 2019 and Sep 22, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination” (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. May 21, 2026Class IIOpen, Classified

   Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

   Z-2666-2026 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2023Defective Component; Defective Component

  IT WAS REPORTED BY CUSTOMER THAT THEY ARE HAVING ISSUES WITH PULLING AIR IN PICCS WHEN THEY ARE CHECKING FOR BLOOD RETURN. THERE SEEMS TO BE A LEAK IN THE STIFFENING WIRE LUMEN THAT CAUSES AIR TO PULL AND NOT BLOOD. RESPONSE RECEIVED 13 SEP 2023 : THIS PULLS AIR INTO THE SALINE SYRINGE WHEN ASPIRATING FOR BLOOD RETURN. IT ALSO CAUSES SALINE TO LEAK OUT OF THE RUBBER STOPPER WHERE THE STIFFENING WIRE EXITS. IT ALSO CAUSES THE BLOOD RETURN CHECK TO BE MISLEADING, THEREFORE LEADING THE INSERTER TO BELIEVE THAT THE PICC IS NOT IN THE PROPER LOCATION. WE HAVE NOTICED THIS OCCURRING DURING MULTIPLE INSERTIONS. NO INJURY HAS OCCURRED TO PATIENTS, BUT POTENTIALLY COULD LEAD TO A MALPOSITIONED PICC PLACEMENT OR EXPELLING AIR FROM THE SYRINGE INTO THE PATIENT'S CENTRAL VENOUS SYSTEM. A SPECIFIC NUMBER OF AFFECTED DEVICES OR PATIENTS WAS NOT PROVIDED BY THE COMPLAINANT. ADDITIONAL INFORMATION RECEIVED: THERE'S NO SAMPLE TO BE RETURNED SINCE THEY HAVE BEEN INSERTED ON PATIENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17800129 ↗
• MalfunctionFeb 15, 2019Contamination

  IT WAS REPORTED THAT THERE WAS AN OPEN SEAM ABOUT ONE INCH BELOW THE LEFT SHOULDER ON THE STERILE GOWN WITHIN THE KIT. ON (B)(6) 2019- ADDITIONAL INFORMATION RECEIVED STATED, " THE CLINICIAN WAS ADVISED TO CHANGE THE GOWN PRIOR TO PROCEEDING WITH INSERTION BUT CHOSE TO UTILIZE THE GOWN FOR THE INSERTION. THE GOWN WAS CONTAMINATED WITH BIOHAZARD AND WAS DISCARDED FOLLOWING COMPLETION OF THE PROCEDURE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8346224 ↗