DELTAPAQ DFS100210-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00878528007616), received between Jan 9, 2017 and Oct 7, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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 16, 2026.

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.

• MalfunctionOct 7, 2021Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A DELTAPAQ 2MMX10CM SR PLAT COIL (DFS10021020, UNKNOWN LOT) WOULD NOT DETACH WHEN IT ARRIVED AT THE SIGHT FOR DEPLOYMENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12590165 ↗
• MalfunctionDec 28, 2017Positioning Failure; Stretched; Positioning Failure; Stretched

  AS REPORTED BY A PHYSICIAN, DURING COIL EMBOLIZATION OF THE RIGHT INTERNAL CAROTID ARTERY, AN ENPOWER DETACHMENT CONTROL BOX (DCB00000500/F42808) WAS UNABLE TO DETACH A DELTAPAQ COIL (DFS10021020/ S14661). UPON ATTEMPTING TO DETACH THE COIL, A RED LIGHT WAS VISIBLE ON THE BOX. THEY TURNED THE BOX OFF AND ON AND THE DCB SEEMED TO REINITIALIZE, BUT THE ACCOUNT USED ANOTHER DCB FOR THE REST OF THE COILING PROCEDURE; HOWEVER, THE DELTAPAQ CONTINUED TO NOT BE ABLE TO DETACH WITH THE NEW BOX. THE COIL WAS REMOVED AND SET ASIDE TO BE RETURNED FOR EVALUATION. THE PHYSICIAN CONTINUED TO SUCCESSFULLY COIL THE RIGHT ICA ANEURYSM WITH NO FURTHER ISSUES USING THE REPLACEMENT DCB. BOTH COMPLAINT PRODUCTS HAD BEEN PREPPED AND USED AS PER THE IFU AND ALL CONNECTIONS FIT PROPERLY WITHOUT NEED FOR EXCESSIVE FORCE. NEITHER DEVICE APPEARED DAMAGED. A PRE-DEPLOYMENT ELECTRICAL CHECK HAD BEEN PERFORMED. IT WAS REPORTED THAT THE PRODUCTS WOULD BE RETURNED FOR ANALYSIS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7153697 ↗
• MalfunctionJan 9, 2017Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  DURING COIL EMBOLIZATION, A DELTAPAQ ((B)(4)) WAS UNABLE TO FIT DOWN THE UNSPECIFIED MICROCATHETER, AND DURING PRODUCT ANALYSIS, IT WAS FOUND THAT THE THE PROXIMAL END OF THE COIL HAD COMPRESSION AND BUCKLING, WHICH WAS UNREPORTED DAMAGE. THEY OPENED THE SAME MODEL OF COIL AND IT WENT DOWN THE CATHETER WITH NO ISSUES. THERE WAS NO PATIENT INJURY OR PROCEDURE DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6232283 ↗