DELTAXSFT DLX100202Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886704077305), received between Nov 22, 2019 and May 28, 2025 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2025Separation Failure; Premature Separation; Separation Failure; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 2MM X 2CM DELTA XSFT 10 (DELTAXSFT / 30942980) COULD NOT BE DETACHED AND HAD TO BE REMOVED FROM THE ANEURYSM. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 28-MAY-2025, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PROCEDURE WAS TARGETING THE ARTERIA MENINGEA MEDIA (MIDDLE MENINGEAL ARTERY). THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT. NO INFORMATION CAN BE OBTAINED ON WHETHER THE COIL WAS STRETCHED WHEN IT WAS REMOVED. THE COIL WAS NO LONGER ATTACHED TO THE DELIVERY SYSTEM WHEN IT WAS REMOVED; THE INFORMATION INDICATED THAT ¿THE COIL DETACHED DURING RETRIEVAL WITHIN THE HUB OF THE MICROCATHETER. COIL WAS REMOVED SUCCESSFULLY.¿ THE INFORMATION INDICATED THAT ¿THE COIL WAS SAVED OUT OF MICROCATHETER HUB, PROCEDURE WAS FINISHED SUCCESSFULLY.¿ NO INFORMATION WAS OBTAINED ABOUT THE CONCOMITANT MICROCATHETER USED; BUT THE SAME MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE. A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. THE FAULT LIGHT WAS NOT SEEN DURING THE CASE. UPON PRESSING THE POWER BUTTON, ALL LIGHTS ILLUMINATED. THE GREEN SYSTEM READY LIGHT DID ILLUMIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22100637 ↗
• MalfunctionMar 8, 2022Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION TO THE ACOM AND WHEN ADVANCING A 2MM X 2CM DELTAXSFT COIL (DLX100202, LOT UNKNOWN) THROUGH A SHEATH INTO A 45 DEGREE SL-10 150CM IN LENGTH MICROCATHETER (MC), THERE WAS A LOT OF RESISTANCE AFTER ADVANCING THE COIL 25% OF THE WAY. STAFF REPEATEDLY PULLED THE TAB BACK TO ENSURE IT WAS NOT IN THE WAY, BUT THE COIL STILL WOULD NOT ADVANCE. THE COIL WAS PULLED OUT AND A NEW COIL WAS OPENED. THERE WAS NO SURGERY DELAYS DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL INFORMATION WAS RECEIVED THAT A GLIDE WIRE WAS USED WITH THIS CATHETER SUCCESSFULLY. THE NEW COIL WAS ALSO USED WITH THE SAME MC AND IT WORKED GREAT. THE MICROCATHETER WAS NOT REMOVED, ONLY THE DEFECTIVE COIL WAS REMOVED. THERE WAS NO DAMAGE TO THE MICROCATHETER DURING MANIPULATION OF THE DEVICE OR NOTICED TO BE DAMAGED UPON REMOVAL FROM THE PATIENT. THE COIL DID NOT APPEAR DAMAGED AT ANY POINT DURING THE PROCEDURE. NOTHING WAS OBSTRUCTING THE MICROCATHETER. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE, THE EMBOLIC COIL WAS OBSERVED TO BE KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13690979 ↗
• MalfunctionDec 16, 2021Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, WHILE PLACING THE 2MM X 2CM DELTAXSFT 10 COIL (DLX100202 / 30537003), IT WAS ¿IMPOSSIBLE TO GET IT LOOSE.¿ ATTEMPT TO TROUBLE SHOOT WAS MADE USING ANOTHER DETACHMENT CONTROL CABLE AND ANOTHER DETACHMENT CONTROL BOX, BUT THIS DID NOT RESOLVE THE ISSUE. IT WAS REPORTED THAT WITH OTHER COILS, THERE WERE NO SIMILAR ISSUES. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13019691 ↗
• MalfunctionAug 5, 2020Stretched; Material Twisted/Bent; Stretched; Material Twisted/Bent

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF AN UNKNOWN TARGET VESSEL/SITE, WHILE ADVANCING A 2MM X 2CMTHE DELTA XSFT COIL (DLX100202, L16827), IT WAS IMPOSSIBLE TO PUSHED OUT INTO THE ECHELON10, MEDTRONIC MICROCATHETER (DLX100202 LOT L16827). EVEN AFTER SEVERAL ATTEMPTS IT WAS NOT POSSIBLE TO PUSH FORWARD THROUGH THE CATHETER. FURTHER COILS WERE EASILY PUSHED IN WITHOUT ANY PROBLEMS. NO PATIENT HARM NOR SURGICAL DELAY REPORTED. THE DEVICE WAS USED AND PREPPED AS PER THE INSTRUCTIONS FOR USE, HOWEVER, IT WAS NOT CHECKED IN ADVANCE. NO EXCESSIVE FORCE HAD BEEN APPLIED TO THE DEVICE. THE EVENT OCCURRED OUTSIDE THE PATIENT. ADEQUATE FLUSH HAD BEEN MAINTAINED THROUGH THE DEVICES. BASED ON THE PRODUCT INVESTIGATION, THE EMBOLIC COIL WAS NOTED TO BEING STRETCHED AND KINKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10367781 ↗
• MalfunctionNov 22, 2019Separation Failure; Material Twisted/Bent; Separation Failure; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE NEUROVASCULAR ANEURYSM TREATMENT PROCEDURE, THE 2MM X 2CM DELTAXSFT 10 COIL (DLX100202 / LOT# UNK) COULD NOT BE DETACHED. THE EVENT RESULTED IN A 5-MINUTE DELAY IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT COIL. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9366027 ↗