DELTAXSFT DLX100254Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886704077275), received between Sep 15, 2017 and Jun 4, 2021 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Kinked” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2021Failure to Advance; Failure to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 2.5MM X 4CM DELTAXSFT 10 COIL (DLX100254 / L12180) WAS NOT WORKING IN THE INTRODUCER SHEATH. 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 COMPLAINT DEVICE WAS RETURNED FOR EVALUATION. DURING THE MICROSCOPIC INSPECTION OF THE RETURNED DEVICE, THE EMBOLIC COIL WAS OBSERVED MECHANICALLY DETACHED AND IN STRETCHED CONDITION. BASED ON THE PRODUCT ANALYSIS ON 03 JUNE 2021, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11939962 ↗
• MalfunctionNov 13, 2018Separation Failure; Separation Failure

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A TRANSVENOUS COIL EMBOLIZATION OF A CAROTID-CAVERNOUS FISTULA, THE 2.5MM X 4CM DELTAXSFT10 (DLX100254/S13589) THERMO-MECHANICAL COIL WAS DELIVERED TO THE TARGET LESION AND THE ¿DETACH¿ BUTTON WAS PRESSED, BUT THE COIL FAILED TO DETACH EVEN THOUGH THE GREEN ¿SYSTEM READY¿ LIGHT WAS ILLUMINATED. THE COIL WAS REPLACED WITH A 2.5MM G3 COIL AND 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 TERUMO SHEATH INTRODUCER, A CHIKAI (ASAHI INTECC) GUIDEWIRE, A 6F FUBUKI (ASAHI INTECC) GUIDING CATHETER, A SL-10 (STRYKER) MICROCATHETER, AN ENPOWER CONTROL CABLE, AND AN ENPOWER DCB2 DETACHMENT CONTROL BOX WERE ALSO USED FOR THE CASE. THE PRODUCT WILL BE RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8065325 ↗
• MalfunctionJun 25, 2018Kinked; Stretched; Kinked; Stretched

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A DELTAXSFT COIL (DLX100254/L10065) WAS USED DURING A PROCEDURE AND IT WAS IMPOSSIBLE TO INTRODUCE THE COIL IN ITS SHEATH. NO FURTHER INFORMATION IS AVAILABLE. NOTE: THIS EVENT WAS DEEMED REPORTABLE AS A RESULT OF THE DEVICE INVESTIGATION FINDINGS.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7636573 ↗
• MalfunctionMar 1, 2018Kinked; Kinked

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, THE 2 MM X 2.5 CM MICRUSFRAME (MFR100202/L10128) AND THE 2.5 MM X 4 CM DELTAXSFT (DLX100254/L10065) THERMO-MECHANICAL COILS FAILED TO RESHEATHE AS EXPECTED DURING THE CASE. BOTH COILS WERE DEPLOYED INSIDE THE ANEURYSM; HOWEVER, THE PHYSICIAN DECIDED THAT HE DID NOT LIKE THE POSITION AND ATTEMPTED TO RESHEATHE THE COILS. THE COILS WERE SUBSEQUENTLY REPLACED WITH NO ADVERSE OUTCOME TO THE PATIENT. ACCORDING TO THE STAFF, THE PHYSICIAN FOLLOWED THE INSTRUCTIONS FOR USE (IFU). THE PHYSICIAN HAD TRADITIONALLY FLUSHED ON THE BACK TABLE BEFORE THE SIDE HOLES WERE ADDED. HOWEVER, THE PHYSICIAN DID NOT DO THIS FOR THIS CASE. THERE WAS A CONTINUOUS FLUSH THROUGH THE MICROCATHETER WHILE THE COILS WERE BEING ADVANCED. THE PRODUCTS WILL BE RETURNED FOR ANALYSIS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7307447 ↗
• MalfunctionFeb 26, 2018Kinked; Physical Resistance; Kinked; Physical Resistance

  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 7296489 ↗
• MalfunctionFeb 20, 2018Kinked; Kinked

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN UNRUPTURED CEREBRAL ANEURYSM AT THE ANTERIOR COMMUNICATING ARTERY, TWO 2.5 MM X 4 CM DELTAXSFT10 THERMO-MECHANICAL COILS (DLX100254/S12101) WERE FLUSHED AND INSERTED INTO THE HEADWAY 10 (TERUMO) MICROCATHETER FROM THE SHEATH BUT GOT STUCK IN THE SHEATH. THE COILS WERE SUBSEQUENTLY REPLACED WITH A COMPETITOR PRODUCT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUE. THE EVENT DID NOT RESULT IN A PROCEDURAL DELAY. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO THE PATIENT. THE PATIENT¿S VESSEL WAS MODERATELY TORTUROUS. IT IS UNKNOWN IF THE VESSEL WAS CALCIFIED. A SYNCHORO/CHIKAI 14 (ASAHI INTECC) GUIDEWIRE, A FUBUKI, (ASAHI INTECC) GUIDE CATHETER, A HEADWAY 10 (TERUMO) MICROCATHETER, AND A SCEPTER (SYORYU) BALLOON CATHETER WERE ALSO USED FOR THE CASE. THE PRODUCTS WERE 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 REPORTED EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. REPORTEDLY, THE PHYSICIAN DID NOT APPLY F

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7282451 ↗
• MalfunctionNov 18, 2017Stretched; Impedance Problem; Stretched; Impedance Problem

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A DELTAXTRASOFT COIL (DLX100254/S12932) ENCOUNTERED RESISTANCE WITH THE SHEATH DURING A COIL EMBOLIZATION PROCEDURE OF A BASILAR TOP ANEURYSM. THE DISTAL TIP OF THE SHEATH INTRODUCER WAS INSERTED INTO A Y-CONNECTOR PER THE IFU, AND THE DELTAXTRASOFT COIL (COMPLAINT PRODUCT) WAS ATTEMPTED TO BE INSERTED; HOWEVER, RESISTANCE WAS FELT. THE COIL WAS REMOVED FROM THE SHEATH AND REPLACED WITH A NEW ONE. THE PATIENT WAS A (B)(6)-YEAR-OLD MALE WHOSE VESSEL WAS MODERATELY TORTUROUS AND MODERATELY CALCIFIED. A GUIDING CATHETER (CHIKAI, ASAHI INTECC) AND A MICROCATHETER (SL 10, STRYKER) WERE ALSO USED FOR THIS PROCEDURE. 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 IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIME. NO VISIBLE DEFECT/DAMAGE WAS NOTED ON THE PRODUCTS PRIOR TO AND AFTER THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICRO CATHETER. THE PRODUCT WILL BE RETURNED FOR THE INVESTIGATION. NO FURTHER I

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7043790 ↗
• MalfunctionSep 15, 2017Physical Resistance; Physical Resistance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF AN UNRUPTURED ANEURYSM, THERE WAS RESISTANCE BETWEEN A DELTAXTRASOFT (DLX100254, S11984) AND A HEADWAY 17 MICROCATHETER, AND DURING COIL RESHEATHING, THE SHEATH INTRODUCER WAS DAMAGED AND THE COIL COULD NOT BE RE-SHEATHED. THE MICRO CATHETER WAS APPROACHED TO THE LESION AS STEAM-SHAPED. ¿THE ONLY INFLOW GOT CLOGGED TIGHTLY WHEN THE COILS (MICRUSFRAMES5X17, MICRUFRAMEC4X8, DELTAXSFT3X6, DELTAXSFT3X6, DELTAXSFT2.5X4) WAS INSERTED¿ , SO THE PHYSICIAN TRIED TO RE-SHEATH THE DELTAXTRASOFT (COMPLAINT PRODUCT), BUT THE SHEATH INTRODUCER GOT DAMAGED AND COULD NOT BE RE-SHEATHED. AFTER THAT, THE MICRO CATHETER WAS REINSERTED, AND THE COIL WAS REPLACED WITH ANOTHER ONE (SAME SIZE) AND ADDITIONAL 6 COILS WERE PLACED IN THE LESION. 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 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 DETA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6869446 ↗