DELTAXSFT DLX100151Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886704077244), received between Feb 21, 2020 and Sep 22, 2021 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2021Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A DELTAXSFT10 1.5MM X 1CM COIL (DLX100151, K10326) FAILED TO DETACH. WITH THIS PHENOMENON, IT WAS RETRACTED FULLY AND REPLACED WITH ANOTHER COIL. THERE WAS NO SURGERY DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS WERE GENERATED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12514945 ↗
• MalfunctionJan 13, 2021Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 1.5MM X 1CM DELTAXSFT10 COIL (DLX100151, L11766) FAILED TO DETACH AFTER DEPLOYING THE COIL INTO THE ANEURYSM. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11163118 ↗
• MalfunctionJan 12, 2021Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 1.5MM X 1CM DELTAXSFT10 COIL (DLX100151, L11766) FAILED TO DETACH AFTER DEPLOYING THE COIL INTO THE ANEURYSM. THERE WAS NO PATIENT INJURY REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11156239 ↗
• MalfunctionSep 28, 2020Stretched; Positioning Problem; Stretched; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 1.5MM X 1CM DELTAXSFT 10 COIL (DLX100151 / L15456) WAS THE FIRST COIL CHOSEN FOR THE PROCEDURE; IT WAS REPORTED THAT THE PHYSICIAN DID NOT LIKE THE SHAPE OF THE COIL DEPLOYMENT AND DECIDED TO REMOVE THE COIL. DURING THE RESHEATHING ATTEMPT, THE COIL INTRODUCER FAILED TO BE RE-ZIPPED. THE PHYSICIAN USED ANOTHER 1.5MM X 1CM DELTAXSFT 10 COIL COIL AS REPLACEMENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10596960 ↗
• MalfunctionFeb 24, 2020Malposition of Device; Malposition of Device

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, A 1.5MM X 1CM DELTAXSFT10 COIL (DELTAXSFT, L16085) WAS BEING USED AS THE FINAL FINISHING COIL. AFTER THE COIL DETACHED AND WAS REMOVED FROM THE EXCELSIOR MICROCATHETER (MC), THERE WAS ¿SOMETHING STICKING OUT¿ AT THE END OF THE MC. THE PROCEDURE WAS WELL COMPLETED. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT ADDITIONAL INTERVENTION. THE DEVICE(S) WERE USED AND PREPPED AS PER THE INSTRUCTIONS FOR USE. THE CONCOMITANT DEVICES FUNCTIONED AS EXPECTED. THERE WAS NO DEVICE FRAGMENTS THAT REMAINED IN THE PATIENT. THERE WAS NO EXCESSIVE FORCE APPLIED TO THE DEVICE. THERE WAS NO DIFFICULTY WITH DEVICE POSITIONING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9745203 ↗
• MalfunctionFeb 21, 2020Positioning Problem; Positioning Problem

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, A 1.5MM X 1CM DELTAXSFT10 COIL (DLX100151, L14830) WAS BEING USED AS THE 5TH COIL, HOWEVER, THE PHYSICIAN DIDN'T LIKE THE SHAPE OF THE COIL DEPLOYMENT AND DECIDED TO PULL IT OUT. DURING RESHEATHING OF THE COIL, THE INTRODUCER FAILED TO BE RE-ZIPPED. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9738526 ↗