MICRUSPHERE SSR180927-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00878528009917), received between Feb 21, 2017 and Mar 14, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Stretched” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 14, 2023Stretched; Premature Separation; Stretched; Premature Separation

  AS REPORTED BY THE FIELD, DURING A DISTAL POSTERIOR CEREBRAL ARTERY ANEURYSM (PCA) MEASURING AT APPROXIMATELY 20 MM IN SIZE, A MICROSPHERE XL 9MMX27CM COIL (SSR18092720, L14899) WAS ADVANCED THROUGH A HEADWAY DUO 156 CM MICROCATHETER (MC) AND STRETCHED TO THE POINT THAT THE COIL DETACHED INSIDE THE MICROCATHETER. THE PHYSICIAN ATTEMPTED TO USE A COIL PUSHER WIRE TO ADVANCE THE COIL THROUGH THE MICROCATHETER INTO THE ANEURYSM UNSUCCESSFULLY. ULTIMATELY, THE DECISION WAS MADE TO TAKE OUT THE MICROCATHETER. FORTUNATELY, THE ENTIRE COIL WAS REMOVED FROM THE BODY. A STRYKER XT17 WAS USED TO REASSESS THE ANEURYSM AND FINISHED COILING WITH 2 TARGET COILS. THIS IS CONSIDERED A VERY COMPLICATED CASE DUE TO THE LOCATION OF THE ANEURYSM. EITHER PRODUCT WAS NOT ALTERED AFTER REMOVAL, FROM THE PATIENT¿S BODY. THIS DID RESULT IN THE DELAY OF PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16536907 ↗
• MalfunctionJul 17, 2017Premature Activation; Stretched; Premature Activation; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, A MICRUSPHERE COIL (SSR18092720/P11729) WAS ADVANCED THROUGH AN ECHELON MICROCATHETER HOWEVER THE COIL WAS STUCK INSIDE THE MICROCATHETER AT THE DISTAL END. THE COIL WAS REMOVED ALONG WITH THE MICROCATHETER. PATIENT WAS NOT EFFECTED BUT THE SURGERY WAS DELAYED BY 10 MINUTES AS THEY WERE REQUIRED TO OPEN ANOTHER COIL AND MICROCATHETER. THERE WERE NO DAMAGES NOTED ON THE COMPLAINT COIL OR THE MICROCATHETER PRIOR TO USE OR UPON REMOVAL. THE COMPLAINT COIL AND THE MICROCATHETER ARE AVAILABLE FOR INVESTIGATION. UPON RECEIVED THE DEVICE FOR INVESTIGATION, ADDITIONAL UNREPORTED DAMAGE WAS FOUND. THE CORE WIRE WAS KINKED, THE EMBOLIC COIL WAS MECHANICALLY DETACHED AND THE PROXIMAL END OF THE COIL WAS STRETCHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6716828 ↗
• MalfunctionFeb 21, 2017Stretched; Stretched

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING AN ANEURYSM COILING PROCEDURE OF AN ANTERIOR COMMUNICATING ARTERY ANEURYSM, A MICROSPHERE COIL (SSR18092720/C10005) BECAME STUCK IN THE MID PORTION OF A COMPETITOR'S MICROCATHETER DURING INSERTION AND WAS STRETCHED WHEN IT WAS REMOVED. THE COIL WAS REMOVED FROM THE CATHETER AND WAS STILL ATTACHED TO THE DELIVERY SYSTEM. THIS WAS THE FIRST COIL ATTEMPTED TO BE DEPLOYED THROUGH THE MICROCATHETER. THERE WERE NO KINKS FOUND ON THE MICROCATHETER. THERE WERE NO DAMAGES NOTED TO THE COIL PRIOR TO USE. IT WAS REPORTED THAT THE COMPLAINT PRODUCT WILL BE RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6345774 ↗