RADSTIC Radiology Microintroducer kit 0669060Recalls & reported problems
Bard Access Systems, Inc. · 6.0 FR RADSTIC · 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 00801741074592), received between May 25, 2022 and May 25, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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
Device problems
- Material Deformation1
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.
MalfunctionMay 25, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT WHEN RADIOLOGY DOCTOR IS TRYING TO INSERT A DUAL LUMEN PICC TODAY, A GUIDE WIRE WAS STUCK INSIDE ONE LUMEN OF A DUAL LUMEN PICC. TO MAINTAIN THE ACCESS, WE OPENED ANOTHER DUAL LUMEN KIT, USED THE 135CM LONG WIRE THAT COMES IN THE DUAL LUMEN PICC PACK TO SWAP OUT THE PICC THAT HAS WIRE STUCK INSIDE. NO HARM CAUSED TO THE PATIENT, WE JUST HAD TO SPEND LONGER TIME FOR THIS PROCEDURE. (B)(6) 2022 - MULTIPLE BENDS AND A SHARP KINK WERE OBSERVED WITHIN THE COIL REGION OF THE RETURNED GUIDEWIRE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14496970 ↗
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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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