Extension Set for PowerPICC SOLO Catheter 1090000Recalls & reported problems
Bard Access Systems, Inc. · Adaptor, PowerPICC · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00801741074714), received between Jul 10, 2025 and Jul 10, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Frayed” (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.
Reports received per month
Most reported problems
Device problems
- Material Frayed1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 10, 2025Material Frayed; Material Frayed
IT WAS REPORTED "LAST WEEK, WE HAD A WIRE BREAK DURING A PICC INSERTION FOR A 4FR PICC (LOT #REJX3266). THIS WAS INSERTED BY ONE OF OUR EXPERIENCED STAFF, WHO REPORTED THE LINE WAS CUT TO 36 CM AND THE COPPER TIP WAS NOT VISIBLE AFTER THE PROCEDURE. A SECOND NURSE CONFIRMED THAT THE WIRE WASN¿T PRESENT IN THE TRIMMED SECTION OF THE PICC, SO THE PATIENT WAS SENT FOR AN X-RAY AS A PRECAUTIONARY MEASURE. THE PATIENT HAS A PACEMAKER IN PLACE SO NEEDED A CHEST X RAY TO CONFIRM PICC TIP PLACEMENT. THE 3CG WIRE WAS PULLED BACK, LINE WAS CUT ONLY WITH THE BLADE PROVIDED. THE CUT WAS SMOOTH WITH NO SENSATION THE WIRE WAS CUT. THE INSERTER WAS CERTAIN THEY SEEN THE COPER SECTION AFTER THEY TRIMMED THE CATHETER AND PULLED IT BACK TO BE IN LINE WITH THE TIP OF THE PICC. THE PICC WAS THEN FLUSHED TO REMOVE MICRO BUBBLES ONTO THE TRAY. SHERLOCK SHOWED LOLLYPOP GOING UP NECK, MULTIPLE ATTEMPTS MADE TO NAVIGATE IT DOWN TOWARDS THE HEART. THE 3CG SHOWED THE PICC TAKING THE TURN TO GO DOWN TOWARDS THE HEART BUT DID COULD NOT GET THE DEPTH PARAMETER TO SHOW THE PICC GOING ALL THE WAY DOWN BUT SINCE THERE WAS GOOD BLOOD RETURN AND LINE FLUSHED EASILY ORDER FOR X RAY WAS ENTERED. THEN WHEN WIRE WAS REM
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22473385 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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