RADSTIC Radiology Microintroducer kit 0669050Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00801741074585), received between Dec 11, 2015 and Oct 27, 2021 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 27, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE INTRODUCER TIP BIFURCATION. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12705945 ↗
• MalfunctionJul 23, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE FRONT END IS NOT STRAIGHT AND STUCK. THE COMPONENT INVOLVED IS THE DILATOR TIP. NO OTHER INFORMATION PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12218024 ↗
• InjuryMar 5, 2021Migration or Expulsion of Device; Loosening of Implant Not Related to Bone-Ingrowth; Migration or Expulsion of Device; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED "THE TIP OF THE WIRE BROKE OFF". PICC INSERTION - R BASILIC VEIN ACCESSED WITH 21G NEEDLE. WIRE THREADED 12-15CM, NEEDLE REMOVED. WIRE AT THIS TIME WOULD NOT MOVE FORWARD OR RETRACT. I PUT MINIMAL TENSION ON WIRE AND IT BROKE, APPROX 9CM (SOFT FLOPPY TIP) REMAINED IN PT.'S ARM, X-RAY OF R ARM APPEARS TO SHOW COILED END GUIDE WIRE NEAR INSERTION SITE. NURSE VIEWED SAM. PT. BEING SENT TO HOSPITAL. INSERTION SITE MARKED WITH ARROW. LIGHTLY TIED TOURNIQUET ABOVE SITE. PT STABLE AT THE TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 11425521 ↗
• MalfunctionAug 13, 2020Material Frayed; Material Frayed

  IT WAS REPORTED A RADSTICK GUIDEWIRE BECAME UNRAVELED AND BROKE WHILE BEING INSERTED INTO THE PATIENT. THE PIECE WAS REMOVED FROM THE PATIENT ON SITE WITHOUT FURTHER SURGERY. ADDITIONAL INFORMATION RECEIVED 8/3/2020: IT WAS REPORTED THE LEFT BASILIC VEIN WAS ACCESSED USING US GUIDANCE. RADSTICK GUIDEWIRE INSERTED AND MET RESISTANCE. DURING REMOVAL OF GUIDEWIRE, HAD UNCOILING OF WIRE AND BREAKAGE INTO TWO (2) PIECES AND END OF GUIDEWIRE LODGED IN PATIENT. RADIOLOGIST REMOVED LODGED GUIDEWIRE UNDER FLUOROSCOPY. NO PATIENT HARM REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10404863 ↗
• MalfunctionJun 30, 2016Uncoiled

  ON (B)(6) 2016 - IT WAS REPORTED BY COMPLAINANT THAT DEVICE WAS PLACED IN THE RIGHT ARM. WHEN PLACING THE DEVICE, THE CONTACT STATED THAT THE WIRE COILED UP AND THE WIRE SHEARED. THE PROCEDURE WAS STOPPED AND A NEW DEVICE PLACED IN THE LEFT ARM SUCCESSFULLY. NO HARM TO THE PATIENT REPORTED. ON (B)(6) 2016 - ENGINEER REPORTS THAT GUIDEWIRE IS MISSING A 2CM PIECE. FACILITY WAS NOTIFIED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5763558 ↗
• MalfunctionDec 11, 2015Sticking; Unraveled Material; Physical Resistance

  REPORTED BY PICC NURSE (NURSE PRACTITIONER): ATTEMPTED TO PLACE THE POWER GLIDE DEVICE AS PER INSTRUCTIONS AND WHEN SHE MET RESISTANCE, SHE ABORTED. WHEN THE DEVICE WAS OUT OF THE PATIENT, SHE TOOK THE "CATHETER" PART OF THE POWER GLIDE DEVICE AND THEN PLACED IT USING MODIFIED SELDINGER TECHNIQUE. SHE USED THE RADSTIC MICROPUNCTURE SET TO PLACE THE DEVICE. BOTH THE NEEDLE AND WIRE IN THE RADSTIC SLID INTO THE PATIENT WITHOUT A PROBLEM. SHE THEN USED THE DILATOR TO DILATE THE VESSEL (OVER THE WIRE). SHE DILATED APPROXIMATELY 2 CM'S, PULLED THE DILATOR OFF THE WIRE AND THEN PLACED THE POWER GLIDE CATHETER OVER THE WIRE AND INTO THE PATIENT. NEXT SHE ATTEMPTED TO COMPLETE THE PROCEDURE BY REMOVING THE GUIDEWIRE AND IT WAS ALLEGEDLY HUNG UP. SHE COULD TELL IT WAS CAUGHT ON SOMETHING SO SHE LEFT IT IN PLACE UNTIL A PHYSICIAN COULD INTERVENE UNDER FLUORO. THE MD REMOVED THE WIRE THE FOLLOWING MORNING AND THE ENTIRE WIRE WAS INTACT BUT DID ALLEGEDLY UNRAVEL FROM THE PROXIMAL END OF THE FLOPPY TIP. THE WIRE WAS COMPLETELY REMOVED AND NOT AVAILABLE FOR US TO EXAMINE, HOWEVER A PHOTO THAT WAS TAKEN OF THE UNRAVELED WIRE ONCE IT WAS REMOVED FROM THE PATIENT IS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5289897 ↗