DuoGlide catheter 5625150Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00801741042096), received between Feb 17, 2017 and Oct 4, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 10, 2026Class IOpen, Classified

   this is a downstream recall of class I recall RES 98777

   Z-2985-2026 · Root cause: Material/Component Contamination · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 4, 2022Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT THE "CATHETER STOPPED WORKING IN THE MIDDLE OF THE SURGERY AT THE END OF THE CASE WHILE REMOVING IT THE TEAM NOTICED THAT PART OF IT IS MISSING DONE X RAY AND FOUND THE PIECE OF REMAINING CATHETER RETAINED IN THE HEART THE PRODUCT REMOVED AND SEND TO PATHOLOGY WITH A NEW CATHETER TO COMPARE THE DEVICE."

  Patient problems: Foreign Body In Patient

  MAUDE report 15540817 ↗
• MalfunctionJun 11, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED WHEN ONE OF OUR INTENSIVISTS OPENED THE KIT TO PLACE THE LINE, HE FOUND A LARGE STRAND OF HAIR PACKAGED IN THE STERILE SUPPLIES. THE KIT WAS NOT UTILIZED AND THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10146024 ↗
• InjuryFeb 17, 2017Device Operates Differently Than Expected

  FACILITY REPORTED TO THE SALES REPRESENTATIVE THAT WHEN THE PRODUCT WAS INSERTED, IT APPEARED TO BE STIFF BUT BECAME SOFT AND FLIMSY DURING INSERTION WHICH CREATED DIFFICULTY WITH PLACEMENT. THIS CAUSED CLOTTING IN USING THIS DEVICE. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME. NO PATIENT INJURY REPORTED.

  Patient problems: Coagulation Disorder

  MAUDE report 6341395 ↗