HydroSoft 3D 7110-0208-3D-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00816777025401), received between Nov 15, 2019 and Nov 12, 2025 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryNov 12, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THE PHYSICIAN WAS PERFORMING AN L ACOMM EMBOLIZATION CASE. TN COILS#1-10 WERE SUCCESSFULLY DEPLOYED WITHOUT ISSUE WITH HEADWAY DUO#1. THE PHYSICIAN INSERTED AN ARISTOTLE 14 GUIDEWIRE, AFTER USING THE GUIDEWIRE SEVERAL TIMES TO RE-POSITION DURING THE CASE, WITH HEADWAY DUO#1 AFTER COIL#10 WAS DEPLOYED TO RE-POSITION ONCE AGAIN. THE ARISTOTLE 14 WOULD NOT ADVANCE INTO THE HEADWAY DUO#1 (B)(4). THE ARISTOTLE 14 WAS REMOVED, AND A SYNCHRO SOFT GUIDEWIRE WAS USED WITHOUT ISSUE TO RE-POSITION. PROCEDURE CONTINUED AND THEN COIL#11 WHICH WOULD NOT ADVANCE INTO THE HUB OF THE HEADWAY DUO #1, TN COIL#11 WAS SET ASIDE AND A NEW HEADWAY DUO#2 WAS OPENED AND CASE CONTINUED WITH COIL#11 BEING INSERTED WITHOUT ISSUE. TN COIL#12 WAS INSERTED INTO HEADWAY DUO#2 AND WOULD NOT ADVANCE. COIL#12 WAS SET ASIDE, AND A NEW COIL WAS CHOSEN. TN COIL#13 WOULD ALSO NOT ADVANCE INTO HEADWAY DUO#2. BOTH HEADWAY DUO#2 AND COIL#13 WERE SET ASIDE FOR RETURN. HEADWAY DUO#3 WAS OPENED AND TN COIL#14 AND #15 INSERTED WITHOUT ISSUE. TN COIL#16 WOULD NOT ADVANCE IN HEADWAY DUO#3 (B)(4). TN COIL#17 OPENED AND DEPLOYED WITHOUT ISSUE. TN COIL#18 ADVANCED INTO HEADWAY DUO#3 WITHOUT ISSUE BUT WOULD NOT FULLY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23539137 ↗
• MalfunctionOct 29, 2025Premature Separation; Premature Separation

  NO ADDITIONAL INCIDENT INFORMATION WAS RECEIVED. HOWEVER, IT WAS REPORTED THAT THE HOSPITAL DID NOT SAVE THE COIL AND MICROCATHETER AND WAS ONLY PROVIDED THE COIL PUSHER BODYCOIL. PLEASE SEE H6 & H11.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23411684 ↗
• InjuryJan 8, 2025Unraveled Material; Detachment of Device or Device Component; Unraveled Material; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Stroke/CVA

  MAUDE report 21103813 ↗
• MalfunctionMar 29, 2022Unraveled Material; Separation Failure

  DURING A COIL EMBOLIZATION OF A MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM, A 2MM X 8MM HYDROSOFT COIL BY MICROVENTION WAS BEING USED IN THE BRAIN AND AS IT WAS TRYING TO BE DETACHED IT WAS NOT WORKING. COIL WAS THEN REMOVED FROM THE HEAD. WHEN THE CATHETER THE COIL WAS INSIDE WAS REMOVED AND THE COIL WAS TAKEN OUT, IT UNRAVELED AND STILL WOULD NOT DETACH.

  Patient problems: Insufficient Information

  MAUDE report 13938044 ↗
• InjuryJan 8, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT COIL EMBOLIZATION TREATMENT WAS INITIALLY PERFORMED ON A MIDDLE MENINGEAL ARTERY ON (B)(6) 2019. APPROXIMATELY FOUR MONTHS LATER ON (B)(6) 2019, A FOLLOW-UP CTA DEMONSTRATED A METAL WIRE IN THE INTERNAL CAROTID ARTERY (ICA). A SECOND PROCEDURE WAS PERFORMED ON (B)(6) 2019 TO REMOVE THE WIRE FROM THE ICA WITH A STENT RETRIEVER. THE PATIENT'S CURRENT STATUS IS REPORTED TO BE "NORMAL."

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9567167 ↗
• MalfunctionNov 15, 2019Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING EMBOLIZATION OF A FISTULA OF THE SIGMOID SINUS, AN EMBOLIZATION COIL IMPLANT COULD NOT BE RETRACTED INTO THE MICROCATHETER. THE COIL DETACHED PREMATURELY IN THE MICROCATHETER AND WAS PUSHED INTO THE TREATMENT AREA. NO PATIENT INJURY OR INTERVENTION WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9330238 ↗