DELTAXSFT DLX100204Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10886704077329), received between Mar 22, 2017 and Feb 19, 2026 — classified as 2 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Stretched” (4 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2026Failure to Advance

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, TWO DELTAFILL10 2MM X 8CM COILS (PRODUCT CODES: DLF100208, LOT NUMBERS 2232554S AND 2232541S) AND A DELTAXSFT10 2MM X 4CM COIL (PRODUCT CODE: DLX100204, LOT NUMBER: 2022553S) COULD NOT BE INSERTED INTO THE ECHELON10, MEDTRONIC MICROCATHETER (MC). ADDITIONAL EVENT INFORMATION INDICATED THAT ANOTHER DELATAFILL AND DELTAXSFT COILS WERE SUCCESSFULLY USED WITH THE MICROCATHETER. THERE WAS NO NEED TO REMOVE OR REPLACE THE MICROCATHETER DURING THE PROCEDURE. THE TARGET VESSEL WAS THE MIDDLE CEREBRAL ARTERY (MCA), AND SPECIFIC ANATOMICAL CHARACTERISTICS¿INCLUDING CALCIFICATION, TORTUOSITY, AND VESSEL DIAMETER¿WERE NOT AVAILABLE. THROUGHOUT THE INTERVENTION, THERE WERE NO OBSERVATIONS OF PHYSICAL DAMAGE TO THE DEVICES, AND NO OBSTRUCTIONS WITHIN THE MICROCATHETER WERE NOTED. A CONTINUOUS FLUSH WAS MAINTAINED FOR THE DURATION OF THE PROCEDURE. BASED ON THE PRODUCT ANALYSIS OF THE RETURNED DEVICE, THE EMBOLIC STENT WAS KINKED AND STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24392872 ↗
• InjuryNov 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE STERLING STUDY, A 67-YEAR-OLD MALE PATIENT (SUBJECT 00971-020), WITH A MEDICAL HISTORY OF CONTROLLED HYPERLIPIDEMIA, CLASS 1 OBESITY (BMI OF 30 TO < 35), CONTROLLED HYPERTENSION AND BEING A CURRENT SMOKER UNDERWENT COIL EMBOLIZATION OF AN UNRUPTURED MIDLINE BASILAR ARTERY ANEURYSM ON (B)(6) 2022. MODIFIED RANKING SCALE (MRS) SCORE WAS 0. PER IMMEDIATE PRE-PROCEDURE DIGITAL SUBTRACTION ANGIOGRAPHY PERFORMED THE ANEURYSM HAD THE FOLLOWING DIMENSIONS: HEIGHT 13MM, DOME 15MM, MAXIMUM ANEURYSM DIAMETER 15MM, NECK SIZE 8.5MM, AND THE DOME-TO-NECK RATIO OF 1.8MM. THE PARENT VESSEL DIAMETER WAS 4.1MM. COIL EMBOLIZATION WAS PERFORMED USING THE FOLLOWING EIGHT (8) CERENOVUS COILS: TWO (2) GALAXY G3 8MM X 24CM (GLY120824/K10393), A GALAXY G3 6MM X 20CM (GLY120620/30490147), A GALAXY G3 6MM X 20CM (GLY120620/ K10607), TWO (2) GALAXY G3 5MM X 15CM (GLY120515/30357953), A GALAXY G3 5MM X 15CM (GLY120515/30422339), A DELTAFILL10 5MM X 15CM (DLF100515/30415692), A DELTAFILL10 5MM X 15CM (DLF100515/30379777), A GALAXY G3 4MM X 12CM (GLY120412/30522183), A DELTAFILL10 2MM X 8CM (DLF100208/30418880), A DELTAFILL10 2MM X 8CM (DLF100208/30407127), TWO DELTAFILL10 2MM X 8CM (DLF100208

  Patient problems: Ruptured Aneurysm

  MAUDE report 15759733 ↗
• MalfunctionJul 6, 2021Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 2MM X 4CM DELTAXSFT 10 COIL (DLX100204 / 30481266) WAS THE 7TH COIL USED IN THE PROCEDURE AND IT WOULD NOT DETACH AFTER THREE DETACHMENT ATTEMPTS. THE COIL WAS SUCCESSFULLY REMOVED FROM THE PATIENT WITH THE COIL STILL ATTACHED TO THE DELIVERY SYSTEM. ANOTHER 2MM X 4CM DELTAXSFT 10 COIL FROM THE SAME LOT WAS USED; THIS REPLACEMENT COIL DETACHED WITHOUT ANY ISSUE USING THE SAME CONCOMITANT SL-10® MICROCATHETER (STRYKER); THE SAME MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. THE LIGHTS ON THE ENPOWER ILLUMINATED WHEN THE POWER BUTTON WAS PRESSED. DURING THE INITIATED DETACHMENT CYCLE, THE DETACHMENT LIGHT ILLUMINATED AND THE AUDIBLE SIGNAL BEEP WAS HEARD. ALL CONNECTION FIT WITHOUT APPLICATION OF EXCESSIVE FORCE. THE REPORTED ISSUE DID NOT RESULT IN ANY DELAY IN THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12125563 ↗
• MalfunctionDec 9, 2019Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE INTRODUCER SHEATH ZIPPER ON THE 2MM X 4CM DELTAXSFT 10 COIL (DLX100204 / L12462) WAS SPLIT. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE PROCEDURE AND THE REPORTED DEVICE ISSUE WERE UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE, THIS FILE WILL BE UPDATED ACCORDINGLY. THE 2MM X 4CM DELTAXSFT 10 COIL WAS RETURNED FOR EVALUATION WHICH REVEALED THAT THE EMBOLIC COIL WAS STRETCHED. BASED ON THE PRODUCT ANALYSIS ON 12/6/2019, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9439297 ↗
• MalfunctionNov 22, 2019Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE COIL EMBOLIZATION TARGETING A BRAIN ANEURYSM, THE 2MM X 4CM DELTAXSFT 10 COIL (DLX100204 / LOT# EITHER L10262 OR L11455) DID NOT DETACH FROM THE DELIVERY WIRE; THE PHYSICIAN RETRACTED THE COIL FROM THE TARGET POSITION. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9364278 ↗
• MalfunctionNov 21, 2019Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE COIL EMBOLIZATION TARGETING A BRAIN ANEURYSM, THE 2MM X 4CM DELTAXSFT 10 COIL (DLX100204 / L11455) DID NOT DETACH FROM THE DELIVERY WIRE; THE PHYSICIAN RETRACTED THE COIL FROM THE TARGET POSITION. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9359434 ↗
• MalfunctionNov 4, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, A 2MM X 4CM DELTAXSFT10 COIL ( DLX100204, L15954) AND A 2MM X 6CM COIL (DLX100206, L15955) COULD NOT PUSH OUT OF THE CATHETER. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE PRODUCT ANALYSIS OF THE DELTAXSFT10 2MM X 4CM, THE EMBOLIC COIL WAS FOUND STRETCHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9271385 ↗
• MalfunctionSep 20, 2018Material Deformation; Material Deformation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A VISCERAL SPLENIC ARTERY ANEURYSM, THE 2MM X 4CM DELTAXSFT10 (DLX100204/S14100) THERMO-MECHANICAL COIL WOULD NOT ADVANCE THROUGH THE INTRODUCER SHEATH. THE COIL WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT. THE SURGERY WAS NOT DELAYED DUE TO THE EVENT. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND A CONSTANT FLUSH WAS MAINTAINED. NO VISIBLE PRODUCT DEFECT/DAMAGE WAS NOTED PRIOR TO AND AFTER THE EVENT. THE PRODUCT WAS PREPPED AND USED ACCORDING TO THE IFU. THERE WAS NO DIFFICULTY EXPERIENCED UNSHEATHING THE COIL. A NEO MEISTER CAS (MEDIKIT) MICROCATHETER AND DCB2 DETACHMENT CONTROL BOX WERE ALSO USED FOR THE CASE. INVESTIGATION OF THE RETURNED PRODUCT REVEALED THAT THE EMBOLIC COIL WAS KINKED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7893911 ↗
• MalfunctionAug 23, 2018Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN ABDOMINAL ARTERY ANEURYSM, THE 2MM X 4CM DELTAXSFT COIL (DLX100204/C40404R) WAS SELECTED FOR USE AS THE FIFTH COIL; HOWEVER, RESISTANCE WAS ENCOUNTERED WHEN THE COIL WAS DELIVERED INTO THE PROWLER LPES MICROCATHETER (UNK CATALOG & LOT) AND THE COIL COULD NOT BE ADVANCED. THE COIL WAS SUBSEQUENTLY REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT OR DELAY. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND A CONSTANT FLUSH WAS MAINTAINED. NO VISIBLE PRODUCT DAMAGE WAS NOTED PRIOR TO THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. A DCB2 DETACHMENT CONTROL BOX WAS ALSO USED FOR THE CASE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7809092 ↗
• MalfunctionMay 4, 2018Positioning Failure; Positioning Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE STENT-GRAFT COIL EMBOLIZATION FOR A TYPE II ENDOLEAK, THE FIRST DELTAXTRASOFT10 2 MM X 4 CM (DLX100204 / S12100) WAS INSERTED INTO THE MICROCATHETER (CARNELIAN MARVEL, TOKAI MEDICAL PRODUCTS) AND CONNECTED TO THE ENPOWER CONTROL CABLE (ECB00018200 / S13941), PRE-DEPLOYMENT ELECTRICAL CHECK WAS SUCCESSFULLY PERFORMED, BUT THE COIL FAILED TO DETACH WHEN THE BUTTON WAS PRESSED ON THE DETACHMENT CONTROL BOX. SEVERAL ATTEMPTS WERE MADE BUT THE COIL DID NOT DETACH. THE ENPOWER CONTROL CABLE WAS REPLACED WITH ANOTHER ENPOWER CONTROL CABLE FROM LOT S13745, BUT THE COIL COULD NOT BE DETACHED EVEN WHEN THE POWER LAMP WAS ILLUMINATED. THE COIL WAS REMOVED; DURING THE COIL REMOVAL, THE MICROCATHETER CAME AWAY ON THE NEAR SIDE. ANOTHER COIL (A GALAXY COIL) WAS USED AND PLACED AT THE FRONT POSITION THAT WAS DIFFERENT FROM THE POSITION ORIGINALLY PLANNED FOR THE DELTAXTRASOFT10 COIL. AFTER THE GALAXY COIL WAS PLACED AT THE FRONT POSITION, ANOTHER VESSEL WAS TARGETED AND A SECOND DELTAXTRASOFT10 2 MM X 4 CM (DLX100204 / S12015) WAS CHOSEN. IT WAS INSERTED INTO THE MICROCATHETER AFTER AN UNEVENTFUL PRE-DEPLOYMENT CHECK WAS PERFORMED. THE BUTTON O

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7488900 ↗
• MalfunctionMay 4, 2018Positioning Failure; Positioning Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE STENT-GRAFT COIL EMBOLIZATION FOR A TYPE II ENDOLEAK, THE DELTAXTRASOFT10 2 MM X 4 CM (DLX100204 / S12100) WAS INSERTED INTO THE MICROCATHETER (CARNELIAN MARVEL, TOKAI MEDICAL PRODUCTS) AND CONNECTED TO THE ENPOWER CONTROL CABLE (ECB00018200 / S13941), PRE-DEPLOYMENT ELECTRICAL CHECK WAS SUCCESSFULLY PERFORMED, BUT THE COIL FAILED TO DETACH WHEN THE BUTTON WAS PRESSED ON THE DETACHMENT CONTROL BOX. SEVERAL ATTEMPTS WERE MADE BUT THE COIL DID NOT DETACH. THE ENPOWER CONTROL CABLE WAS REPLACED WITH ANOTHER ENPOWER CONTROL CABLE FROM LOT S13745, BUT THE COIL COULD NOT BE DETACHED EVEN WHEN THE POWER LAMP WAS ILLUMINATED. THE COIL WAS REMOVED; DURING THE COIL REMOVAL, THE MICROCATHETER CAME AWAY ON THE NEAR SIDE. ANOTHER COIL (A GALAXY COIL) WAS USED AND PLACED AT THE FRONT POSITION THAT WAS DIFFERENT FROM THE POSITION ORIGINALLY PLANNED FOR THE DELTAXTRASOFT10 COIL. THE PHYSICIAN COMMENTED THAT THE VESSEL WAS VERY STEEP WHICH RESULTED IN DIFFICULTY IN ADVANCING THE COIL DELIVERY SYSTEM TO THE MIDDLE PORTION. IT WAS ADVANCED BY FORCIBLY PUSHING THE CATHETER TIP; THE COIL DELIVERY SYSTEM BECAME KINKED IN THE FRONT OF THE HUB AND WAS L

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7488894 ↗
• MalfunctionFeb 26, 2018Kinked; Stretched; Kinked; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A PRE-TUMOR COIL EMBOLIZATION OF A LEFT MIDDLE MENINGEAL ARTERY (MMA) ANEURYSM, THE PHYSICIAN ATTEMPTED TO DEPLOY THE DELTAXSFT10 2 MM X 6 CM (DLX100206/C40691) AND DELTAXSFT10 2 MM X 4 CM (DLX100204/C40595) THERMO-MECHANICAL COILS IN SALINE PRIOR TO INSERTING INTO THE MICROCATHETER; HOWEVER, THE COILS CAME OUT OF THE SIDE OF THE SHEATH INSTEAD OF THE TIP. THE COILS WERE REPLACED WITH A DELTAXSFT10 2.5 MM X 4 CM (DLX100254, C40597) THERMO-MECHANICAL COIL. THE COIL WAS INSERTED INTO THE MICROCATHETER WITHOUT ANY ISSUE, BUT STRONG RESISTANCE WAS FELT WHEN THE COIL WAS PLACED. THE COIL WAS NOT ABLE TO BE PUSHED OR PULLED IN THE COIL INTRODUCER. THE COIL WAS SUBSEQUENTLY REPLACED WITH A GALAXY COIL. THERE WAS NO REPORT OF PATIENT INJURY. DUE TO THESE TWO EVENTS, THE PROCEDURE WAS DELAYED 40 MINUTES. THE EMBOLIZATION WAS STARTED FOR THE NUTRIENT VESSELS OF THE LT-MMA. THE PATIENT¿S VESSEL WAS MILDLY TORTUROUS AND NOT CALCIFIED. A CARNELIAN MARVEL (TOKAI MEDICAL PRODUCTS) MICROCATHETER AND DCB02 DETACHMENT CONTROL BOX WERE ALSO USED FOR THIS PROCEDURE. THE PRODUCTS WERE STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCOR

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7296492 ↗
• InjurySep 21, 2017Stretched; Device Operates Differently Than Expected; Stretched; Device Operates Differently Than Expected

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A DELTAXSFT COIL (DLX100204/S11999) WAS STRETCHED IN THE COIL MASS DURING A PROCEDURE. THE DELTAXSFT COIL (COMPLAINT PRODUCT) WAS SMOOTHLY ADVANCED INTO AN ANEURYSM AND THEN RETRACTED BACK INTO THE MICROCATHETER. WHEN THE PHYSICIAN RE-ADVANCED IT A LOT OF RESISTANCE WAS FELT. THE PHYSICIAN TRIED TO PULL IT BACK INTO THE MICROCATHETER AND ALSO HAD RESISTANCE AS THE MICROCATHETER HAD ¿LOCKED UP¿. THE COIL WAS STUCK IN THE COIL MASS. THE DOCTOR ENDED UP CUTTING THE COIL PUSHER AND SHEATH, THE MICROCATHETER IN AN ATTEMPT TO SNARE IT. THE SNARE WOULD NOT ADVANCE. HE THEN HELD DISTAL END OF THE WIRE AND TRIED PUSHING THE MICROCATHETER BACK OVER THE COIL. AT THIS TIME, IT EASILY ADVANCED AND THE PHYSICIAN WAS ABLE TO PULL THE COIL OUT; THE COIL WAS STRETCHED. THE PHYSICIAN WAS ABLE TO FINISH THE CASE WITH NO PATIENT COMPLICATIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6883672 ↗
• MalfunctionMar 22, 2017Positioning Failure; Physical Resistance; Positioning Failure; Physical Resistance

  THE CONTACT FROM THE FACILITY REPORTED THAT THERE WAS RESISTANCE WHEN ADVANCING THE DELTAXSFT COIL (DLX100204/C41703) THROUGH THE END OF THE EXCELSIOR SL-10 MICROCATHETER. THE DOCTOR WAS COILING A 6MMX5MM UNRUPTURED ANTERIOR COMMUNICATING ARTERY ANEURYSM. AFTER HE SUCCESSFULLY PLACED THE EXCELSIOR SL-10 MICROCATHETER HE DECIDED THAT A 6X15 CASHMERE WOULD BE AN APPROPRIATE FIRST COIL. AFTER SUCCESSFULLY PLACING THAT COIL HE SUBSEQUENTLY PLACED THE FOLLOWING COILS WITHOUT ISSUE: ONE CASHMERE 3X6, TWO ULTIPAQ 2X3, AND ONE ULTIPAQ 2X2. HE THEN DECIDED THAT HE WOULD LIKE TO USE OUR DELTAXSFT 10 2X4 COIL (COMPLAINT PRODUCT) TO FINISH. THE DOCTOR PREPARED THE COIL PER THE IFU AND BEGAN TO ADVANCE IT THROUGH THE MICROCATHETER WITHOUT ISSUE. WHEN THE COIL REACHED THE END OF THE SL-10 THE DOCTOR SAID HE COULD FEEL A GREAT DEAL OF ¿DRAG¿ AND WAS UNABLE TO ADVANCE THE COIL OUT OF THE MICROCATHETER. AFTER REPOSITIONING THE MICROCATHETER TWICE, HE WAS STILL UNABLE TO ADVANCE THE COIL. HE THEN APPLIED ¿A GOOD DEAL OF FORCE¿ TO THE PUSHER WIRE AND THE COIL ADVANCED AND WAS PLACED INTO THE ANEURYSM. THE DOCTOR THEN PRESSED THE DETACH BUTTON AND BEGAN TO PULL THE DELIVERY WIRE OUT. AN ENPOWER CONNEC

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6424743 ↗