DELTAXSFTRecalls & reported problems across all models

We found 13 models of DELTAXSFT by Cerenovus, Inc. in the FDA's device registry (GUDID). Together they are named in 130 adverse event reports in the FDA's MAUDE database, received between Feb 16, 2017 and Sep 17, 2026 — classified as 1 death, 12 injuries, 117 malfunctions.

The most frequently reported specific device problem is “Stretched” (34 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported DELTAXSFT problems

DELTAXSFT models

13 models, most reported first. Each model has its own page with its reports, recalls and device details.

• DELTAXSFT DLX100206

  Device, Vascular, for Promoting Embolization
  39 reports
• DELTAXSFT DLX100306

  DEVICE, NEUROVASCULAR EMBOLIZATION
  21 reports
• DELTAXSFT DLX100204

  Device, Vascular, for Promoting Embolization
  14 reports
• DELTAXSFT DLX100153

  Device, Vascular, for Promoting Embolization
  13 reports
• DELTAXSFT DLX100152

  Device, Vascular, for Promoting Embolization
  1 death11 reports
• DELTAXSFT DLX100254

  DEVICE, NEUROVASCULAR EMBOLIZATION
  8 reports
• DELTAXSFT DLX100151

  DEVICE, NEUROVASCULAR EMBOLIZATION
  6 reports
• DELTAXSFT DLX100256

  Device, Vascular, for Promoting Embolization
  6 reports
• DELTAXSFT DLX100202

  Device, Vascular, for Promoting Embolization
  5 reports
• DELTAXSFT DLX100408

  DEVICE, NEUROVASCULAR EMBOLIZATION
  3 reports
• DELTAXSFT DLX100203

  Device, Vascular, for Promoting Embolization
  2 reports
• DELTAXSFT DLX100304

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• DELTAXSFT DLX100406

  Device, Vascular, for Promoting Embolization
  1 report

Recent DELTAXSFT adverse event reports

The 15 most recent reports across all models, 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 ↗
• MalfunctionMay 28, 2026Separation Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION, A DELTAXSFT10 3MM X 6CM COIL (PRODUCT CODE: DLX100306, LOT NUMBER: 2022554S) COULD NOT BE DEPLOYED. EVEN WITH A SECOND RELEASE DEVICE. THERE WAS NO PATIENT HARM. THERE WAS NO SIGNIFICANT DELAY. ADDITIONAL EVENT INFORMATION RECEIVED ON 22-MAY-2026 CONFIRMED THAT THE COIL JUST COULDN¿T DETACH UPON SYSTEM ACTIVATION. THE COIL WAS IN THE RIGHT POSITION. THERE WAS NO COIL HERNIATION. THE COIL DID NOT PROTRUDE INTO THE PARENT VESSEL. THE PROCEDURE WAS COMPLETED. THERE WAS NO ALLEGATION OF PATIENT INJURY DUE TO AN ALLEGED PRODUCT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25317413 ↗
• 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 ↗
• 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 ↗
• InjuryNov 18, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT TWO DELTAXSFT10 3MM X 6CM (DLX100306/ 31188524) MICRO-COILS WERE USED FOR AN ENDOVASCULAR EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE USER REPORTED COIL IMPEDIMENT IN THE MICROCATHETER FOR BOTH COILS. THE EVENTS RESULTED IN A 25-MINUTE PROCEDURAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE EVENT WAS INITIALLY REPORTED AS SUCH, ¿CUSTOMER HAS ANOTHER COMPLAINT, AGAIN COILS GOT STUCK IN THE CATHETER (SL-10) OR COULD NOT BE INSERTED. BEFORE THE COIL GOT STUCK, THE PREVIOUS COILS COULD EASILY BE PUSHED THROUGH THE SAME CATHETER. COIL AND CATHETER WILL BE SENT IN FOR EXAMINATION.¿ ON 07-NOV-2024, ADDITIONAL INFORMATION WAS RECEIVED. SUMMARY: PER THE INFORMATION, THE PATIENT IS A 66-YEAR-OLD CAUCASIAN FEMALE WITH A MEDICAL HISTORY OF DEPRESSION AND MIGRAINE. THE TARGET VESSEL WAS THE MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION THE INFORMATION INDICATED THAT ¿MICROCATHETERS WERE CONTINUOUSLY FLUSHED WITH HEPARINIZED SALINE AT FULL SPEED ALL THE TIME.¿ THE SL-10 MICROCATHETER WAS REMOVED AND REPLACED BY AN ECHELON-10 MICROCATHETER. RELEVANT ANATOMICAL INFORMATION WAS NOTED AS ¿NO RELEVANT TORTUOSITY, MCA 2.5MM, NO CALCIFICATIO

  Patient problems: Thromboembolism

  MAUDE report 20708319 ↗
• MalfunctionSep 12, 2024Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A DELTAXSFT10 4MM X 6CM COIL (DLX100406, 31131286) COULD NOT BE PUSHED THROUGH A SL-10 MICROCATHETER (MC). THE COILS BEFORE AND AFTER COULD BE PUSHED THROUGH THE SAME CATHETER INTO THE ANEURYSM WITHOUT ANY PROBLEMS. THERE WAS A 10-MINUTE PROCEDURAL DELAYS DUE TO THE EVENT, THE DELAY WAS NOT CLINICALLY SIGNIFICANT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ADDITIONAL EVENT INFORMATION RECEIVED INDICATED THAT THE RESISTANCE WAS FELT MID TO DISTAL OF THE MICROCATHETER. THERE WAS DAMAGE NOTED ON THE DEVICE. THERE WAS NOTHING NOTED TO BE OBSTRUCTING THE MICROCATHETER. A CONTINUOUS FLUSH WAS MAINTAINED. THE INTRODUCER WAS FLUSHED UNTIL LIQUID WAS VISIBLE AT THE DISTAL END OF THE SLIT IN THE CLEAR TUBE. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE RHV DURING DEVICE ADVANCEMENT. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20201370 ↗
• MalfunctionMay 7, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A DELTAXSFT10 4MM X 8CM COIL (DLX100408, 30784459) DID NOT DETACH. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19259186 ↗
• MalfunctionApr 17, 2024Break; Difficult to Remove; Premature Separation; Break; Difficult to Remove; Premature Separation

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A DELTAXSFT10 2MM X 6CM COIL (DLX100206, 30921357) COULD NOT BE REMOVED FROM HOOP / STRONG RESISTANCE OCCURRED, SO PHYSICIAN DID NOT PULL ANY FURTHER. OTHER CNV COILS WERE USED TO FINISH THE PROCEDURE. BASED ON ADDITIONAL INFORMATION RECEIVED ON 10-APR-2024, THE COIL WAS SEPARATED FROM DPU, DPU WIRE APPEARED STRETCHED. THE REMAINDER OF THE COIL WILL BE RETURNED FOR INSPECTION. THERE WAS NO PATIENT INJURY AS THE DEVICE WAS NOT CLINICALLY USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19126925 ↗
• MalfunctionDec 21, 2023Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING COIL EMBOLIZATION TO THE RIGHT RIGHT ANTERIOR COMMUNICATING ARTERY, , A DELTAXSFT10 3MM X 6CM COIL (DLX100306, 30498375) WAS ADVANCED INTO THE MICROCATHETER AND STOPPED BEFORE REACHING DETACHMENT ZONE. THE MICROCATHETER (MC) WAS AN ECHELON 10. ADDITIONAL COILS WERE PLACED WITH NO ISSUES. NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE RESISTANCE HAPPENED IN THE DISTAL PART OF THE MICROCATHETER. A DELTAFILL COIL WAS USED PRIOR TO THE RESISTANCE AND SEVERAL STRYKER COILS AFTER. THE MC WAS NOT REMOVED, AND THEY CONTINUE USING IT. THERE WERE NO NOTED ANATOMY DIFFICULTIES. NO, DAMAGE VISIBLE ON THE DEVICE. THERE WAS NOTHING NOTED TO BE OBSTRUCTING THE MICROCATHETER. A CONTINUOUS FLUSH ON THE MICROCATHETER WAS MAINTAINED. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE RHV DURING DEVICE ADVANCEMENT. BASED ON THE PRODUCT ANALYSIS, THE EMBOLIC COIL WAS FOUND STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18373943 ↗
• MalfunctionSep 27, 2023Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A DELTAXSFT10 3MM X 6CM COIL (DLX100306, 30921363) DID NOT DETACH. OTHER COILS WERE USED BEFORE AND AFTER WITHOUT ANY PROBLEM. THERE WERE NO PROCEDURAL DELAYS DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17825445 ↗
• 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 ↗
• 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 17656950 ↗
• 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 ↗
• MalfunctionMay 25, 2022Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF THE CAROTID ARTERY, A 3MM X 6CM DELTAXSFT10 COIL (DLX100306, 30481268) WAS ATTEMPTED TO BE PLACED AND WOULD ONLY ADVANCE HALFWAY INTO THE ECHELON 10 MICROCATHETER (MC). IT WAS NOT NECESSARY TO REMOVE OR REPLACE THE MC. NEITHER THE COIL OR THE MC APPEARED TO BE DAMAGED. NOTHING WAS OBSTRUCTING THE MICROCATHETER. THE PROCEDURE WAS COMPLETED BY USING A COMPETITOR¿S COIL. THERE WAS NO PATIENT INJURY REPORTED. BASED ON THE DEVICE ANALYSIS OF THE PRODUCT RECEIVED, THE EMBOLIC COIL WAS FOUND SLIGHTLY STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14498213 ↗
• 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 ↗

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