HydroSoft 3D 7110-0256-3D-A2Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00816777025432), received between Sep 12, 2018 and Nov 7, 2024 — classified as 5 injuries, 1 malfunction.

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

• InjuryNov 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION WAS PROVIDED, PLEASE SEE H6 & H11.

  Patient problems: Aneurysm expansion

  MAUDE report 20631233 ↗
• InjuryJul 17, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PLACEMENT OF AN EMBOLIZATION COIL IN AN ANEURYSM, THE COIL UNEXPECTEDLY DETACHED IN THE VESSEL. THE DETACHED COIL SEGMENT WAS RETRIEVED FROM THE PATIENT WITH A COMANECI DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10292688 ↗
• InjuryJun 19, 2020Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING TREATMENT OF AN ACOM ANEURYSM, THE EMBOLIZATION COIL WAS REPOSITIONED TWICE. DURING THE 3RD ATTEMPT TO WITHDRAW THE COIL, THE COIL STRETCHED AND THEN DETACHED, LEAVING A 5-6CM REMNANT IN A PORTION OF THE A1 SEGMENT AND THE PARENT INTERNAL CAROTID ARTERY. AFTER AN EXCHANGE OF MICROCATHETERS, A STENTRIEVER WAS USED TO CAPTURE THE ENTIRE DETACHED COIL SEGMENT FROM THE PATIENT. THE ANEURYSM WAS SUCCESSFULLY TREATED WITH SUBSEQUENT COILS. THERE WAS NO REPORTED PATIENT INJURY. THE PATIENT IS CURRENTLY REPORTED TO BE STABLE AND DOING WELL POST-PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10176114 ↗
• MalfunctionJun 9, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PLACEMENT OF AN EMBOLIZATION COIL INTO A SMALL ANEURYSM, THE MICROCATHETER SLIPPED INTO THE PARENT ARTERY. THE MICROCATHETER WAS TRACKED OVER THE COIL TO RE-ACCESS THE ANEURYSM. WHILE TRYING TO ADVANCE THE LAST LOOP IN THE ANEURYSM, THE COIL DETACHED IN THE MICROCATHETER. THE COIL WAS PUSHED INTO THE ANEURYSM WITH 50/50 CONTRAST/SALINE USING A 3ML SYRINGE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10131627 ↗
• InjuryJun 5, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING EMBOLIZATION OF A PCOM ANEURYSM, THE COIL WAS BEING USED AS A GUIDEWIRE TO GAIN ACCESS TO THE ANEURYSM. DURING THIS MANIPULATION, THE COIL DETACHED AND OVER HALF OF THE COIL WAS IN THE PARENT VESSEL. THE COIL WAS RETRIEVED WITH A STENTRIEVER AND AN ASPIRATION CATHETER. THERE WAS NO REPORTED SYMPTOMS OR INJURIES RELATED TO THE COILING OR RETRIEVAL OF THE COIL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8672190 ↗
• InjurySep 12, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A BALLOON-ASSISTED COILING PROCEDURE WAS PERFORMED ON A PATIENT WITH A RECURRENT BASILAR TIP SACCULAR ANEURYSM. AFTER DELIVERY OF A BALLOON CATHETER INTO THE POSTERIOR CEREBRAL ARTERY, TWO COILS WERE SUCCESSFULLY PLACED IN THE ANEURYSM. SUBSEQUENTLY, A COIL LOOP WAS NOTED TO PROJECT AT THE BASILAR BIFURCATION, MORE TOWARDS THE ORIGIN OF THE RIGHT P1 ARTERY. THE BALLOON WAS INFLATED MULTIPLE TIMES, WHICH REPOSITIONED THE COIL MASS AND CENTRALIZED THE COIL LOOP AT THE BASILAR BIFURCATION. BOTH POSTERIOR CEREBRAL ARTERIES WERE PATENT. THE DECISION WAS MADE TO STOP TREATMENT AT THAT POINT AND MAINTAIN THE PATIENT ON DUAL ANTIPLATELET THERAPY FOR 3 MONTHS. THE PATIENT AWOKE FROM GENERAL ANESTHESIA NEUROLOGICALLY INTACT AND WAS REPORTED TO BE STABLE WITH NO NEW NEUROLOGICAL DEFICITS UPON HOSPITAL DISCHARGE. THE PATIENT IS ENROLLED IN A POST-MARKET CLINICAL TRIAL AND IS BEING MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7871434 ↗