VortX™ Diamond - 18 M0013822040Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08714729324881), received between Oct 24, 2018 and Jan 15, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination” (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

Recent adverse event reports

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

• MalfunctionJan 15, 2019Contamination; Contamination

  IT WAS REPORTED THAT THE DEVICE BECAME UNSTERILE. A 4MM/3.7MM VORTX DIAMOND - 18 WAS SELECTED FOR USE. DURING PREPARATION, THE DEVICE BECAME UNSTERILE/FILTHY BECAUSE IT JUMPED OUT AND WAS DROPPED WHILE THE NURSE IS HANDING THE DEVICE TO THE DOCTOR; DEVICE BECAME UNUSABLE. THERE WAS A TENDENCY THAT IT JUMPED OUT WHEN THE DEVICE WAS TAKEN OUT AFTER THERE IS NO MORE MOUNT/PASTEBOARD. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 8249511 ↗
• MalfunctionOct 24, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 05-OCT-2018. IT WAS REPORTED THAT THE COIL WAS STUCK IN THE CATHETER. A 4MM/3.7 MM VORTX DIAMOND - 18 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT BE PUSHED OUT AND IT WAS STUCK. FURTHERMORE, AFTER WITHDRAWING THE CATHETER AND COIL OUTSIDE THE PATIENT, THE PHYSICIAN PUSHED IT OUT WITH HIGH PERSISTENCE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS POST-PROCEDURE WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE MAIN COIL ZAP TIP WAS DETACHED AND NOT RETURNED. DEVICE EVALUATED BY MFR: THE DEVICE WAS RETURNED FOR ANALYSIS. THE COIL, THE COIL PLUNGER AND THE COIL INTRODUCER WERE RETURNED FOR THIS COMPLAINT; THE RETAINING CLIP WAS NOT RETURNED. THE COIL RETURNED INSIDE THE COIL INTRODUCER. THE COIL WAS DEPLOYED AND SOME RESISTANCE WAS FELT DURING THE PROCEDURE. MICROSCOPIC INSPECTION OF THE MAIN COIL REVEALED THAT THE MAIN COIL SHOWED SOME DAMAGES INDICATING IT WAS HIGHLY MANIPULATED. THE MAIN COIL HAD A DETACHED ZAP TIP AND IT WAS NOT RETURNED; THE OTHER ZAP TIP HAS A SMOOTH SURFACE. BESIDES, THE MAIN COIL WAS STRETCHE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8002248 ↗