PowerPICC SOLO2 Catheter 3295155Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00801741028113), received between Nov 3, 2017 and Aug 28, 2024 — classified as 2 deaths, 2 injuries, 3 malfunctions.

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

• MalfunctionAug 28, 2024Crack; Crack

  IT WAS REPORTED THAT POWERPICC LINE INSERTED ON OUTPATIENT. TECH FLUSHED LINES WITH SALINE, POST INSERTION AND THE RED HUB WAS LEAKING. TECH THEN PERFORMED A PICC EXCHANGE. INSPECTED THE HUB, THERE WAS A LONG CRACK WHEN THE SYRINGE ATTACHES. NO SERIOUS INJURY TO PATIENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20092648 ↗
• InjuryFeb 26, 2021Break; Off-Label Use

  IT WAS REPORTED THAT PIECE OF THE STYLET BROKE OFF INTO THE PATIENT DURING FLUOROSCOPY PLACEMENT. THERE¿S A SMALL PIECE THAT BROKE IN THE PATIENT ABDOMEN AS HE WAS USING THE STYLET TO CHANGE AN ABDOMINAL DRAIN. PT WASN¿T INJURED BUT THE PIECE IS STILL THERE. THIS WAS AN OFF LABEL USE OF THE STYLET MADE FOR THE PICC INSERTION BECAUSE THEY COULDN¿T FIND A SMALL GUIDEWIRE TO USE. HE SAID THE STYLET GOT STUCK. NOTE: DR DOESN¿T WANT ANY FOLLOW-UP.

  Patient problems: Foreign Body In Patient

  MAUDE report 11388605 ↗
• DeathApr 11, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEW HOURS AFTER PICC INSERTION THE PATIENT DIED. FACILITY REPORTED UNCOMPLICATED BASILICA PLACEMENT IN THE IR SUITE UNDER FLUOROSCOPY. PATIENT WAS TRANSFERRED FROM IR SUITE TO SHORT TERM FLOOR. PATIENT REPORTEDLY DEVELOPED DYSPNEA AND A RASH AND CODED TWO HOURS AFTER PICC PLACEMENT. CHG IS "PORED ON PATIENT AND THE 5 ML IS PAINTED ON." THE CHG IS ALLOWED TO DRY FOR MORE THAN 3 MINUTES. FACILITY REPORTS THAT DEATH IS DUE TO HEART DISEASE AND UNRELATED TO PICC PLACEMENT.

  Patient problems: Cardiac Arrest; Death; Dyspnea; Rash

  MAUDE report 8503914 ↗
• DeathApr 10, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A FEW HOURS AFTER PICC INSERTION THE PATIENT DIED. FACILITY STATED UNCOMPLICATED BASILIC PLACEMENT IN IR SUITE UNDER FLUOROSCOPY. FACILITY REPORTED USE OF MORE THAN 5 ML OF CHG. PICC WAS INSERTED AT 14:48. PATIENT WAS STABLE AFTER PICC INSERTION. AFTER PROCEDURE PATIENT DEVELOPED HYPOTENSION, CODED AND TIME OF DEATH WAS REPORTEDLY 17:25. PATIENT HAS A HISTORY OF HEPATIC CIRRHOSIS, DYSLIPIDEMIA, SEVERE ARTERIAL STENOSIS AND HYPONATREMIA. FACILITY ALLEGES MAST CELL REACTION CONTRIBUTED TO REPORTED EVENT.

  Patient problems: Cardiopulmonary Arrest; Death; Low Blood Pressure/ Hypotension; Reaction

  MAUDE report 8500155 ↗
• MalfunctionJul 5, 2018Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT "ONLY ONE SIDE OF THE HUB BROKE OFF WHEN BREAKING THE HUB APART." NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7664749 ↗
• MalfunctionApr 24, 2018Device Dislodged or Dislocated

  IT WAS REPORTED THAT BARD POWER PICC DOUBLE LUMEN LINE WAS PLACED AT 43 CM IN THE RIGHT ARM ON (B)(6) 2018 AT 11:21; TIP VERIFIED IN SVC. AT 13:26 PICC WAS FOUND TO BE AT 23CM, INTERNAL RADIOLOGY WAS NOTIFIED. IT WAS STATED THAT AT 15:10, PICC LINE WAS FOUND ON THE FLOOR AND PATIENT WAS FOUND BLEEDING FROM INSERTION SITE. A STERILE DRESSING WAS APPLIED PER POLICY AND NO FURTHER BLEEDING WAS NOTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 7456176 ↗
• InjuryNov 3, 2017Break; Entrapment of Device

  IT WAS REPORTED BY MS AND S THAT THE NURSE STATED THE GUIDEWIRE BROKE DURING INSERTING A SOLO PICC IN THE INTERVENTIONAL RADIOLOGY DEPARTMENT. THE NURSE WOULD LIKE TO PERFORM AN MRI TO LOCATE THE WIRE AND WANTS TO KNOW IF THE WIRE IS MRI SAFE. MS AND S INFORMED THE CALLER THAT THIS IS A STAINLESS STEEL WIRE AND IS NOT SAFE FOR MRI. I CALLED THE FACILITY AND THEY REPORTED THE GUIDEWIRE IS CURRENTLY IN THE TISSUE AND THE PHYSICIAN HAS MADE THE DECISION NOT TO REMOVE IT.

  Patient problems: Foreign Body In Patient

  MAUDE report 7000960 ↗