DELTAPAQ DFS100515-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00878528007807), received between Nov 5, 2018 and Nov 5, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (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 16, 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.

• MalfunctionNov 5, 2018Separation Failure; Material Twisted/Bent; Separation Failure; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE TO ISOLATE THE VEIN WHICH FORMED A BUBBLE ON A (B)(6)-YEAR OLD MALE PATIENT WITH A MEDICAL HISTORY OF ARTERIOVENOUS FISTULA, THE DELTAPAQ 10 STRETCH RESISTANT 5MM X 15CM COIL (DFS10051520 / S10355) FAILED TO DETACH AT THE SITE OF THE TARGET LESION. THE COIL WAS REMOVED AND DURING REMOVAL, THE COIL BECAME BENT AND THE DELIVERY WIRE BECAME DAMAGED. IT WAS CONFIRMED THAT NO DAMAGE WAS NOTED ON THE DEVICE PRIOR TO ITS USE DURING THE PROCEDURE. THE REPORTED ISSUE DID NOT CAUSE ANY PATIENT ADVERSE EVENT AND RESULTED IN NO PROCEDURAL DELAY. THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS; THE DEVICE WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8040000 ↗
• MalfunctionNov 5, 2018Separation Failure; Material Twisted/Bent; Separation Failure; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE TO ISOLATE THE VEIN WHICH FORMED A BUBBLE ON A (B)(6) YEAR OLD MALE PATIENT WITH A MEDICAL HISTORY OF ARTERIOVENOUS FISTULA, THE DELTAPAQ 10 STRETCH RESISTANT 5MM X 15CM COIL (DFS10051520/S10355) FAILED TO DETACH AT THE SITE OF THE TARGET LESION. THE COIL WAS REMOVED AND DURING REMOVAL, THE COIL BECAME BENT AND THE DELIVERY WIRE BECAME DAMAGED. IT WAS CONFIRMED THAT NO DAMAGE WAS NOTED ON THE DEVICE PRIOR TO ITS USE DURING THE PROCEDURE. THE REPORTED ISSUE DID NOT CAUSE ANY PATIENT ADVERSE EVENT AND RESULTED IN NO PROCEDURAL DELAY. THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS; THE DEVICE WAS DISCARDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8039988 ↗