DELTAXSFT DLX100203Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886704077312), received between Feb 24, 2017 and Jun 5, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Kinked” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2018Kinked; Kinked

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE TO TREAT A GASTROINTESTINAL HEMORRHAGE CASE, THE MICROCATHETER WAS FLUSHED AND THE DELTAXSFT10 2 MM X 3 CM (DLX100203 / S13388) WAS INSERTED INTO THE HUB OF THE INTRODUCER BUT THE COIL COULD NOT BE ADVANCED THROUGH THE INTRODUCER. THE INTRODUCER WAS REMOVED ONCE AND FLUSHED BEFORE THE PHYSICIAN ATTEMPTED TO INSERT THE COIL AND ADVANCE IT THROUGH THE INTRODUCER; THE COIL COULD NOT BE ADVANCED AND BECAME STUCK IN THE INTRODUCER TIP. THE COIL WAS REMOVED AND REPLACED. IT WAS CONFIRMED THAT THE PRESCORE AREA OF THE INTRODUCER WAS NOT OPENED AND THE COIL AND THE DEVICE POSITIONING UNIT (DPU) WAS NOT EXPOSED. THE COIL AND THE DPU DID NOT PROTRUDE FROM THE INTRODUCER. THE TARGET SITE AND VESSEL CHARACTERISTIC WAS NOT KNOWN. AFTER THE COIL WAS REPLACED, THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUE OR DELAY. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION; THE PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED ON THE PRODUCT PRIOR TO TH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7569932 ↗
• InjuryFeb 24, 2017Positioning Failure; Premature Activation; Physical Resistance; Positioning Failure; Premature Activation; Physical Resistance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING AN ELECTIVE RECOILING PROCEDURE OF THE 7 MM X 7 MM ANTERIOR COMMUNICATING ARTERY ANEURYSM WITH A 3 MM NECK, A DELTAXSFT COIL (DLX100203/ S12014) FAILED TO DETACH, AND DURING ATTEMPTED RETRIEVAL, BECAME ENTANGLED WITH PREVIOUS COILS, DETACHED AND PROLAPSED OUT OF THE ANEURYSM. THE PROLAPSED COIL WAS SECURED TO THE VESSEL WALL BY A STENT; HOWEVER, DURING ATTEMPT TO ADVANCE THE ENTERPRISE STENT (ENF401612/ 10621542) THROUGH A PROWLER SELECT PLUS MICROCATHETER (606S255X/ 17610383) FRICTION WAS FELT. THERE WAS NO REPORT OF PATIENT INJURY DUE TO THE EVENTS, AND THE PROCEDURE WAS DELAYED 10 MINUTES TO IMPLANT THE ENTERPRISE. THERE WERE INITIALLY TWO SPECTRA COILS ADVANCED AND DEPLOYED WITHOUT INCIDENT (GLY120510/ S11510 AND DLX100254/ C41705). THE THIRD COIL (COMPLAINT PRODUCT) WAS ADVANCED INTO POSITION SUCCESSFULLY WITH NO RESISTANCE DURING ADVANCEMENT THROUGH THE SL 10 MICROCATHETER. DURING THE FIRST AND ONLY ATTEMPTED DETACHMENT, THE COIL DID NOT DETACH USING THE NEW SPECTRA BOX WITH THE ORANGE PLACARD (CATALOG/LOT UNK). THE PHYSICIAN ATTEMPTED TO RETRIEVE THE COIL; HOWEVER, IT BECAME ENTANGLED WITH PREVIOUSLY IMPLANTED COILS AND DETACH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6356144 ↗