DELTAPAQ DFS100204-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00878528007586), received between Oct 26, 2016 and Oct 26, 2016 — classified as 1 malfunction.

The most frequently reported specific device problem is “Positioning Failure” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 26, 2016Positioning Failure; Positioning Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DELTAPAQ COIL (DFS10020420/P11001) COULD NOT BE DETACHED IN AN ANTERIOR COMMUNICATING ARTERY ANEURYSM DURING A COILING PROCEDURE IN A (B)(6) MALE PATIENT. IT WAS REPORTED THAT THE GREEN LIGHT OF THE DETACHMENT BOX ILLUMINATED, THE DETACHMENT LIGHT ILLUMINATED DURING THE DETACHMENT CYCLE AND THE AUDIBLE SIGNAL BEEPED. THE COIL DID NOT DETACH EVEN AFTER THE CABLE (UNKNOWN) WAS EXCHANGED. A SL-10 MICROCATHETER WAS USED FOR THE PROCEDURE. THE COMPLAINT COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT AND NO DAMAGES WERE NOTED ON THE COMPLAINT COIL UPON REMOVAL. THERE WERE NO DAMAGES NOTED ON THE COIL PRIOR TO USE. THERE WERE NO ADVERSE EVENTS DUE TO THE REPORTED EVENT. THE PROCEDURE WAS COMPLETED USING A SAME LIKE PRODUCT. IT WAS REPORTED THAT THE COMPLAINT COIL IS AVAILABLE FOR RETURN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6057399 ↗