DELTAXSFT DLX100153Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10886704077268), received between Oct 20, 2017 and Sep 17, 2026 — classified as 3 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Stretched” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Device Difficult to Setup or Prepare

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50809177 ↗
• MalfunctionAug 30, 2023Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN EXTERNAL CAROTID ARTERY EMBOLIZATION DUE TO A GUNSHOT WOUND, THE PHYSICIAN ENCOUNTERED ISSUES WITH FOUR (4) COILS. THE FIRST TWO COILS, A 11MM X 37CM MICRUSFRAME 18 (MFR181137 / 30537032) AND A 12MM X 40CM MICRUSFRAME 18 (MFR181240 / 30670821) WOULD NOT DETACH AFTER MORE THAN FIVE (5) CYCLES WERE MADE TO ATTEMPT TO DETACH THEM. THE THIRD COIL, A 1.5MM X 2CM DELTAXSFT 10 (DLX100152 / 30633423) AND THE FOURTH COIL, A 1.5MM X 3CM DELTAXSFT 10 (DLX100153 / 30652463) WOULD NOT ADVANCE DUE TO BROKEN STRING ON THE LOCK MECHANISM. THE PHYSICIAN MOVED TO A DIFFERENT PRODUCT TO FINISH THE PROCEDURE. THERE WAS NO REPORT OF INJURY TO THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ON 13-JUL-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PATIENT IS A MALE UNDER 18 YEARS OF AGE. THE CONCOMITANT MICROCATHETER USED FOR ALL THE COILS WAS A 0.017 ID HEADWAY® DUO 156 MICROCATHETER (MICROVENTION). THE ADDITIONAL INFORMATION RELATED TO THE 11MM X 37CM MICRUSFRAME 18 (MFR181137 / 30537032) INDICATED THE FOLLOWING: THE COIL WAS NOT STRETCHED WHEN IT WAS REMOVED, IT WAS STILL ATTACHED TO THE DELIVERY SYSTEM. A PRE-DE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17656954 ↗
• MalfunctionSep 28, 2020Material Twisted/Bent; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE CEREBRAL ANEURYSM REPAIR PROCEDURE, IT WAS REPORTED THAT THE 1.5MM X 3CM DELTAXSFT 10 COIL (DLX100153 / L16826) WOULD NOT ADVANCE OUT OF THE COIL INTRODUCER INTO THE MICROCATHETER HUB. THE COIL WAS REMOVED AND REPLACED WITH ANOTHER COIL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY PROCEDURAL DELAY. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. DURING THE VISUAL / MICROSCOPIC INSPECTION OF THE RETURNED DEVICE, THE EMBOLIC COIL WAS OBSERVED TO BE IN KINKED CONDITION. BASED ON THE PRODUCT ANALYSIS 9/25/2020, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10596983 ↗
• MalfunctionJul 28, 2020Stretched; Material Twisted/Bent; Stretched; Material Twisted/Bent

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, RE-SHEATHING FAILED WITH A 1.5MM X 3CM DELTAXSFT10 (DLX100153, L15277 ) AND A 6X15 OG TDL CMPLX FILL COIL (640CF0615, 17710987). THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NO PATIENT INJURY REPORTED. BASED ON THE FINDINGS OF THE DEVICE INVESTIGATION, THE EMBOLIC COIL WAS NOTED TO BEING STRETCHED AND KINKED ON THE DELTAXSFT10. THE EMBOLIC COIL WAS FOUND STRETCHED ON THE OG TDL CMPLX FILL COIL .

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10333059 ↗
• MalfunctionApr 6, 2020Material Twisted/Bent; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE, THE 150CM X 5CM 90 DEG TIP PROWLER SELECT LPES WAS USED TO DELIVER DIFFERENT COILS. THE TWO 1.5MM X 3CM DELTAXSFT 10 COILS (DLX100153 / L16826) AND (DLX100153 / L16148) COULD NOT BE ADVANCED THROUGH THE MICROCATHETER. RESISTANCE WAS FELT AT THE PROXIMAL END OF THE MICROCATHETER SHAFT. THERE WAS NO REPORT OF ANY PHYSICAL MATERIAL OBSTRUCTING THE MICROCATHETER. IT WAS REPORTED THAT OTHER COILS WERE SUCCESSFULLY INTRODUCED AND ADVANCED THROUGH THE SAME MICROCATHETER BOTH BEFORE THE REPORTED ISSUE WITH THESE TWO COILS AND AFTER THE REPORTED ISSUE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. DURING THE VISUAL / MICROSCOPIC INSPECTION OF THE RETURNED DEVICE, THE EMBOLIC COIL WAS OBSERVED TO BE IN KINKED CONDITION. BASED ON THE PRODUCT ANALYSIS 4/3/2020, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9931699 ↗
• MalfunctionApr 6, 2020Fracture; Stretched; Fracture; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE, THE 150CM X 5CM 90 DEG TIP PROWLER SELECT LPES WAS USED TO DELIVER DIFFERENT COILS. THE TWO 1.5MM X 3CM DELTAXSFT 10 COILS (DLX100153 / L16148) AND (DLX100153 / L16826) COULD NOT BE ADVANCED THROUGH THE MICROCATHETER. RESISTANCE WAS FELT AT THE PROXIMAL END OF THE MICROCATHETER SHAFT. THERE WAS NO REPORT OF ANY PHYSICAL MATERIAL OBSTRUCTING THE MICROCATHETER. IT WAS REPORTED THAT OTHER COILS WERE SUCCESSFULLY INTRODUCED AND ADVANCED THROUGH THE SAME MICROCATHETER BOTH BEFORE THE REPORTED ISSUE WITH THESE TWO COILS AND AFTER THE REPORTED ISSUE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. DURING THE VISUAL / MICROSCOPIC INSPECTION OF THE RETURNED DEVICE, THE EMBOLIC COIL WAS OBSERVED TO STUCK INSIDE THE INTRODUCER IN STRETCHED AND BROKEN CONDITION. BASED ON THE PRODUCT ANALYSIS 4/3/2020, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9931698 ↗
• MalfunctionJan 3, 2020Product Quality Problem; Product Quality Problem

  THE HEALTHCARE PROFESSION REPORTED THAT AFTER THE PLACEMENT AND IMPLANTATION OF THREE MEDTRONIC COILS: 4MM X 8CM AXIUM¿, 2MM X 2CM AXIUM¿, AND 1.5MM X 3CM AXIUM¿, THE 1.5MM X 3CM DELTAXSFT 10 COIL (DLX100153 / L16177) WAS THE FOURTH AND FINISHING COIL FOR THE PROCEDURE. AFTER IT WAS DETACHED AND IMPLANTED, THE PHYSICIAN NOTICED THAT THERE WAS SOMETHING STICKING OUT AT THE END OF THE MICROCATHETER AND QUESTIONED IF IT WAS A FAULTY COIL OR PART OF THE COIL DESIGN. THE PHYSICIAN REPORTED THAT THIS HAS BEEN OBSERVED BEFORE. THERE WAS NO REPORT OF ANY PATIENT INJURY OR COMPLICATION. FOUR IMAGES WERE PROVIDED FOR AN INDEPENDENT PHYSICIAN REVIEW.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9546191 ↗
• MalfunctionOct 21, 2019Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING AN EMERGENCY COIL EMBOLIZATION FOR PELVIC HEMORRHAGE, A 1.5MM X 3CM DELTAXSFT10 COIL (DLX100153, S14213) WAS INSERTED INTO A VELOUTE ULTRA, ASAHI INTECC MICROCATHETER (MC) BUT IT BECAME ¿STUCK¿. IT COULD NOT ADVANCE AT ALL. THE COIL WAS REMOVED FROM THE MC AND A 1.5MM X 3CM GALAXY G3 MINI (GLM915030, L14163) WAS INSERTED INTO THE MC BUT THE SAME ISSUE OCCURRED. THEREFORE, THE COIL WAS REMOVED THE MC AND ANOTHER G3 MINI GALAXY OF THE SAME SIZE WAS USED AND IMPLANTED AT THE TARGET LESION WITHOUT ANY PROBLEMS. TWO COILS (1.5X3 G3MINI), A COIL (2*8 G3XSFT), A COIL (2*4 G3MINI), A COIL (1.5*2 G3MINI), THREE COILS (3X8 G3), A COIL (2X8 G3XSFT) AND A COIL (4X10 G3) WERE IMPLANTED AND THE PROCEDURE WAS COMPLETED. THE EVENT DID NOT RESULT IN A CLINICALLY SIGNIFICANT PROCEDURAL DELAY. THE CUSTOMER STATES THERE IS NO ADDITIONAL INFORMATION AVAILABLE. BASED ON THE ANALYSIS OF THE DEVICE, THE EMBOLIC COIL OF THE DELTAXSFT10 WAS STRETCHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9213622 ↗
• InjuryMay 16, 2019Entrapment of Device; Migration; Entrapment of Device; Migration

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE TARGETING A RUPTURED 5.5MM X 4.4MM (3MM X 2.5MM NECK) RUPTURED ANEURYSM WITH SUBARACHNOID HEMORRHAGE (SAH) AND ¿NORMAL VESSEL,¿ THE 1.5MM X 3 CM DELTAXSFT 10 COIL (DLX100153 / LOT# UNKNOWN) WAS ONE OF THE FIVE CERENOVUS COILS IMPLANTED IN THE ANEURYSM. THIS COIL WAS SUSPECTED TO HAVE BECOME ENTANGLED WITH THE LAST COIL CHOSEN TO BE USED IN THE CASE, ANOTHER 1.5MM X 3 CM DELTAXSFT 10 COIL (DLX100153 / L10670) THAT HAD BECOME PREMATURELY DETACHED DURING THE ATTEMPT TO INSERT THE IT INTO THE ANEURYSM. THE PREVIOUSLY PLACED 1.5MM X 3 CM DELTAXSFT 10 COIL FOLLOWED THE PREMATURELY DETACHED COIL OUT OF THE ANEURYSM AND MIGRATED OUT INTO THE PROXIMAL A2 SEGMENT OF THE ANTERIOR CEREBRAL ARTERY (ACA), WHERE IT LIKELY CONTRIBUTED TO THE ARTERIAL OCCLUSION AT THE A2 SEGMENT AND WAS SECURED TO THE VESSEL WALL WITH AN UNSPECIFIED STENT. IT WAS REPORTED THAT THERE WAS ENTANGLEMENT BETWEEN THIS COIL AND THE PREMATURELY DETACHED COIL THAT IT FOLLOWED OUT; HOWEVER, PARTS OF THIS COIL REMAINED IN THE ANEURYSM. THE DURATION OF THE ARTERIAL FLOW OBSTRUCTION DUE TO THE EVENT IS NOT CLEAR, BUT IT WAS REPORTED THAT IT COULD H

  Patient problems: Infarction, Cerebral; No Code Available; Obstruction/Occlusion

  MAUDE report 8618231 ↗
• InjuryApr 26, 2019Entrapment of Device; Premature Activation; Activation, Positioning or Separation Problem; Migration; Entrapment of Device; Premature Activation; Activation, Positioning or Separation Problem; Migration

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE OF A RUPTURED ANTERIOR CEREBRAL ARTERY (ACA) ANEURYSM WITH SUBARACHNOID HEMORRHAGE (SAH), THE 1.5MM X 3 CM DELTAXSFT 10 COIL (DLX100153 / L10670) WAS SELECTED AS THE LAST COIL TO BE USED IN THE CASE; IT WAS INSERTED INTO THE MICROCATHETER (UNKNOWN BRAND) AND PARTIALLY DEPLOYED WHEN IT STOPPED MOVING FORWARD. THE COIL COULD NOT BE ADVANCED FORWARD AND IT COULD NOT BE RETRACTED BACK; THE PHYSICIAN DECIDED TO REMOVE THE MICROCATHETER AND ¿LEAVE A LITTLE BIT OF THE COIL OUTSIDE OF THE ANEURYSM.¿ WHILE THE MICROCATHETER WAS BEING RETRIEVED, THE EMBOLIC COIL UNINTENDEDLY DETACHED AND MIGRATED TO THE DISTAL M4 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA). AT THIS TIME, AN UNSPECIFIED COIL FOLLOWED OUT OF THE ANEURYSM AND OBSTRUCTED BLOOD FLOW IN THE A2 SEGMENT OF THE ACA REQUIRING THE PHYSICIAN TO STENT IT TO THE VESSEL WALL. IT WAS REPORTED THAT THE PATIENT HAD UNSPECIFIED POST-PROCEDURE COMPLICATIONS. ADDITIONAL INFORMATION REQUEST IS IN PROGRESS.

  Patient problems: Infarction, Cerebral; No Code Available; Obstruction/Occlusion

  MAUDE report 8558119 ↗
• InjuryMar 4, 2019Migration; Premature Separation; Migration; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE THAT WAS TARGETING THE 4 MM X 4.5 MM X 3.5 MM INTERNAL CAROTID ARTERY ANEURYSM WITH THE PARENT ARTERY DESCRIBED AS ¿SIMPLE ANATOMY,¿ THE PHYSICIAN WAS ADVANCING THE 1.5MM X 3CM DELTAXSFT 10 COIL (DLX100153 / L10630) THROUGH THE SL-10® MICROCATHETER (STRYKER) TO FINISH THE PROCEDURE, WHEN THE COIL BECAME PREMATURELY DETACHED AT THE DETACHMENT ZONE ON THE DEVICE POSITIONING UNIT IN THE MICROCATHETER AND TRAVELED DISTALLY INTO THE NEUROVASCULATURE. IT WAS REPORTED THAT ADEQUATE FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER; THERE WAS NO REPORT OF RESISTANCE BETWEEN THE EMBOLIC COIL AND THE MICROCATHETER PRIOR TO THE REPORTED PREMATURE DETACHMENT, AND THERE WAS NO DAMAGE ON THE MICROCATHETER. IT WAS REPORTED THAT THE DISTAL END OF THE MICROCATHETER WAS IN THE ANEURYSM, BUT THE COIL WAS NOT DEPLOYING CORRECTLY FROM THE DISTAL END OF THE MICROCATHETER. THE PHYSICIAN TRIED TO REPOSITION THE MICROCATHETER AND THE DEVICE POSITIONING UNIT (DPU) BECAME DETACHED FROM THE MICROCOIL AND THE COIL MIGRATED TO THE M3/M4 SEGMENTS. THE COIL DID NOT BECOME SEPARATED INTO TWO OR MORE PIECES; AND THERE WAS NO REDUCTIO

  Patient problems: No Code Available

  MAUDE report 8388451 ↗
• MalfunctionJul 16, 2018Stretched; Stretched

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A DELSTAXSFT COIL (DLX100153/S13537) WAS ATTEMPTED TO BE USED DURING A PROCEDURE, BUT WAS OVERSIZE FOR THE LESION AND COULD NOT BE RESHEATHED. WHEN THE PHYSICIAN ATTEMPTED TO RESHEATH THE DELTAXSFT COIL, THE INTRODUCER DID NOT COVER THE WIRE AND THE COIL COULD NOT BE RESHEATHED AT ALL. THE PHYSICIAN SUSPECTED THAT THE SHEATH WAS DAMAGED DURING PEEL AWAY. IT IS UNKNOWN AS TO HOW THE PROCEDURE WAS COMPLETED. A DCB2 WAS ALSO USED FOR THIS PROCEDURE. THERE WAS NO DAMAGE NOTED TO THE DEVICE PRIOR TO THE PROCEDURE. THE PHYSICIAN DID NOT EXPERIENCE ANY DIFFICULTY WHILE UNSHEATHING THE COIL. THERE WAS NO APPLICATION OF EXCESSIVE FORCE APPLIED TO THE DEVICE. THERE WAS ALSO NO PATIENT INJURY / COMPLICATION REPORTED. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIME. NO VISIBLE DEFECT/DAMAGE WAS NOTED ON THE PRODUCTS PRIOR TO THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE PRODUCT WILL BE RETURNED FOR THE INVESTIGATION. NO FURTHER INFORMATION IS AVAILABLE. NOTE: THIS EVENT W

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7690970 ↗
• MalfunctionOct 20, 2017Kinked; Stretched; Physical Resistance; Kinked; Stretched; Physical Resistance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF THE INFERIOR PETROSAL SINUS, A DELTAXSFT10 1.5MM X 3CM COIL (DLX100153/S13174) WAS IMPEDED IN THE SL-10 MICROCATHETER. THE FIRST AND SECOND COIL (TARGET, STRYKER) WERE USED THEN THE DELTAXSFT10 1.5MM X 3CM WAS OPENED FOR THE THIRD COIL. THE COIL WAS ADVANCED TO THE REVERSE-T, BUT THE COIL DID NOT COME OUT FROM THE DISTAL OF THE MICROCATHETER. THE COIL WAS REPLACED WITH ANOTHER ONE (SAME SIZE) IN CASE OF SUSPICIOUS OF UNRAVELED COIL, AND WAS ADVANCED. EVEN THOUGH THE 2ND MARKER OF THE MICROCATHETER WAS HIDDEN JUST BY THE DISTAL MARKER OF THE GUIDING CATHETER (FUBUKI) AND COULD NOT BE ALIGN THE POSITION OF MARKERS, THE COIL WAS DETACHED SUCCESSFULLY AND THE PROCEDURE WAS COMPLETED. AFTER THE PROCEDURE, THERE WAS POSSIBILITY THAT THE MICROCATHETER HAD STRETCHED BECAUSE THE CATHETER WAS CONSIDERABLY OVERWORKED, BUT IT WAS UNCLEAR. NO UNRAVELED COIL WAS OBSERVED VISUALLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS ALSO NO PATIENT INJURY / COMPLICATION REPORTED. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6964154 ↗