DELTAXSFT DLX100256Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886704077282), received between Nov 1, 2018 and Apr 22, 2022 — classified as 6 malfunctions.

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

• MalfunctionApr 22, 2022Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE TO TREAT AN AFFERENT VESSEL RUPTURE, THE PHYSICIAN DECIDED TO CLOSE THE LESION WITH COILS. THE PHYSICIAN NOTICED THAT THE 2.5MM X 6CM DELTAXSFT 10 COIL (DLX100256 / 30375948) DID ¿NOT NAVIGATE INSIDE THE PROWLER 14 MICROCATHETER (CATALOG/LOT NUMBER UNKNOWN).¿ THE PHYSICIAN REPLACED THE 2.5MM X 6CM DELTAXSFT 10 COIL WITH COMPETITOR COILS WHICH HE WAS ABLE TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH. THE PATIENT IS REPORTED TO BE IN STABLE CONDITION. THERE WAS NO PATIENT ADVERSE EVENT OR PATIENT COMPLICATION ASSOCIATED WITH THE REPORTED ISSUE. ON (B)(6) 2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE TARGET OF THE PROCEDURE WAS THE GREAT CEREBRAL VEIN; THE PATIENT HAD A MALFORMATION. THE INFORMATION ALSO PROVIDED CLARIFICATION ON THE STATEMENT, ¿THE COIL DOES NOT NAVIGATE INSIDE THE PROWLER 14¿ AS FOLLOWS: THE COIL WAS NOT IMPLANTED, IT GOT STUCK AT THE DISTAL PART OF THE INTRODUCER SHEATH. THE INFORMATION INDICATED THAT AFTER GETTING STUCK, THERE WAS A LOT OF RESISTANCE PUSHING THE COIL BOTH TOWARD THE PROXIMAL AND DISTAL. IT WAS REPORTED THAT OTHER DEVICES WERE SUCC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14190198 ↗
• MalfunctionOct 8, 2021Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A DELTAXSFT10 2MM X 6CM COIL (DLX100206, 30481267) BECAME STUCK IN A NON-JOHNSON & JOHNSON MICROCATHETER (MC) WHILE ADVANCING INTO THE ANEURYSM. THE COIL WAS NOT ABLE TO BE ADVANCED. THERE WAS ALSO RESISTANCE INSIDE THE INTRODUCER SHEATH WITH A DELTAXSFT10 2.5MM X 6CM COIL (DLX100256, 30508791). IT IS UNKNOWN EXACTLY WHERE THE RESISTANCE WAS ENCOUNTERED. THERE WAS NO PATIENT INJURY REPORTED. OTHER CERENOVUS COILS WERE SUCCESSFULLY USED WITH THE MICROCATHETER PRIOR TO OR AFTER THE ENCOUNTERED RESISTANCE. IT WAS NOT NECESSARY TO REMOVE THE MICROCATHETER. THERE DID NOT APPEAR TO BE ANY DAMAGE TO THE DEVICES AT ANY TIME. THERE WAS NOTHING NOTED TO BE OBSTRUCTING THE MICROCATHETER. A CONTINUOUS FLUSH WAS MAINTAINED. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICES. BASED ON THE ANALYSIS OF THE DELTAXSFT10 2MM X 6CM, THE EMBOLIC COIL WAS FOUND DAMAGED. ALSO, THE EMBOLIC COIL OF THE DELTAXSFT10 2.5MM X 6CM WAS FOUND STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12601474 ↗
• MalfunctionAug 31, 2020Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 2.5MM X 6CM DELTAXSFT 10 COIL (DLX100256 / L15595) FAILED TO DETACH DURING THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PHYSICIAN MADE 10 ATTEMPTS TO DETACH THE COIL. IT WAS REPORTED THAT THE PROCEDURE WAS DELAYED, THE DURATION OF THE DELAY WAS NOT REPORTED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10472272 ↗
• MalfunctionMay 1, 2019Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE STENT-ASSISTED COIL EMBOLIZATION PROCEDURE ON THE (B)(6)-YEAR-OLD FEMALE PATIENT WITH AN ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM WITH A 6.1 NECK, USING THE LVIS® JR STENT (MICROVENTION) AND SPECTRA DELTA COILS, THE PHYSICIAN WAS ATTEMPTING TO ADVANCE THE 2.5 MM X 6 CM DELTAXSFT 10 COIL (DLX100256 / L12209) IN THE SL-10® MICROCATHETER (STRYKER) WHEN THE COIL BECAME STRETCHED IN THE MICROCATHETER. THE REPORTED EVENT OCCURRED DURING THE COIL INSERTION THROUGH THE MICROCATHETER, BEFORE IT EXITS THE MICROCATHETER. THE COIL DID NOT PREMATURELY DETACH IN THE MICROCATHETER. IT WAS CONFIRMED THAT THERE WERE NO KINKS ON THE MICROCATHETER THAT MAY HAVE CONTRIBUTED TO THE COIL BECOMING STRETCHED; NO COIL ENTANGLEMENT WITH PREVIOUSLY PLACED COILS. THERE WAS NO BLOOD FLOW RESTRICTION OR REDUCTION ASSOCIATED WITH THE REPORTED EVENT. THE COIL INTRODUCER WAS NOT DAMAGED, CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. THE PHYSICIAN WAS ABLE TO USE THE SAME SIZE DELTA COIL TO REPLACE THIS DEFECTIVE COIL AND SUCCESSFULLY IMPLANTED IN THE PATIENT USING THE SAME SL-10® MICROCATHETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8570108 ↗
• MalfunctionDec 21, 2018Migration; Migration

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, FOLLOWING DEPLOYMENT OF THE NEXT TO LAST THERMO-MECHANICAL COIL, 2.5MM X 6CM DELTAXSFT10 (DLX100256/L11405), THE EMBOLIC COIL TAIL PROTRUDED FROM THE ANEURYSM INTO THE PARENT VESSEL. FOLLOWING DEPLOYMENT OF THE LAST THERMO-MECHANICAL COIL, 2MM X 6CM DELTAXSFT10 (DLX100206/L10697), A SECOND COIL LOOP PROTRUDED FROM THE ANEURYSM INTO THE PARENT VESSEL. THE PHYSICIAN MENTIONED THAT THERE WERE ISSUES RELATED TO COIL SHAPE WHICH HE BELIEVES RESULTED IN COIL PROTRUSION. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THESE EVENTS. PRELIMINARY REVIEW OF THE IMAGING PROVIDED CONFIRMED COIL PROTRUSION. IT WAS REPORTED THAT THE INFORMATION PROVIDED FOR THIS COMPLAINT WAS ALL OF THE DETAILS THAT WERE KNOWN/AVAILABLE REGARDING THESE EVENTS. NO FURTHER INFORMATION COULD BE OBTAINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8192542 ↗
• MalfunctionNov 1, 2018Stretched; Material Twisted/Bent; Stretched; Material Twisted/Bent

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN ANEURYSM, THE SURGEON INSERTED THE 2.5MM X 6CM DELTAXSFT10 (DLX100256/L11405) THERMO-MECHANICAL COIL INTO THE PROWLER SELECT LPES 45 DEG TIP (606S155FX/17769648) BUT THE COIL COULD ONLY BE ADVANCED APPROXIMATELY 10 CENTIMETERS (CM). THE COIL WAS REMOVED FROM THE MICROCATHETER AND REPLACED WITH A NEW COIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME MICROCATHETER AND SPECTRA COILS. THE SURGERY WAS DELAYED 10 MINUTES DUE TO THE ISSUE. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. POST-PROCEDURE, THE SURGEON ATTEMPTED TO ADVANCE THE COMPLAINT COIL INTO THE MICROCATHETER AND ENCOUNTERED THE SAME ISSUE. OTHER PRODUCTS WERE USED SUCCESSFULLY WITH THE CONCOMITANT MICROCATHETER PRIOR TO THE ENCOUNTERED RESISTANCE. NO VISIBLE PRODUCT DAMAGE WAS NOTED PRIOR TO AND FOLLOWING THE EVENT. THE CONCOMITANT MICROCATHETER WAS NOT DAMAGED IN ANY WAY. THE PRODUCT WAS PREPPED AND USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THE VESSEL DID NOT HAVE ACUTE BENDS OR EXCESSIVE TORTUOSITY. EVALUATION OF THE RETURNED PRODUCT REVEALED EM

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8027637 ↗