MICRUSPHERE SSR100714-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00878528009825), received between Aug 14, 2018 and Apr 26, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Stretched” (2 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.

• MalfunctionApr 26, 2024Fracture; Fracture

  AS REPORTED BY THE FIELD, THIS WAS A COIL EMBOLIZATION TO A LEFT ANTERIOR COMMUNICATING ARTERY ANEURYSM (ACOMM) WITH HIGH TORTUOSITY. THE PHYSICIAN ATTEMPTED TO COIL ANEURYSM INITIALLY WITH ONLY COILS. FIRST COIL WAS A UNIFORM 7MM X 30 CM (FCX100730, 31127140). THIS SPECIFIC ANEURYSM HAD A LEDGE TOWARDS THE NECK OF THE ANEURYSM THAT CAUSED A HEADWAY DUO 156CM MICROCATHETER (MC) TO BECOME UNSTABLE. BECAUSE OF THE LEDGE, BECAUSE OF THE FORCE NEEDED TO ADVANCE THE COIL INTO THE ANEURYSM, THE COIL FRACTURED AT THE JUNCTION OF THE COIL AND THE PUSHER WIRE. THE 5 FR SOFIA WAS ADVANCED AND THE COIL WAS TAKEN OUT WITH THE MICROCATHETER AS A UNIT. THE ENTIRE COIL WAS REMOVED. NEW MICROCATHETER WAS USED TO RE-ACCESS THE ANEURYSM. THE SECOND COIL, A UNIFORM 7MM X 13.9 CM (FCX100713, 31098464) WAS ADVANCED INTO THE ANEURYSM WITHOUT ANY ISSUE. ATTEMPTED TO DETACH COIL WITH MECHANICAL DETACHMENT HANDLE (MDH1, 102109430) UNSUCCESSFULLY. THE MANUAL BREAK WAS USED CORRECTLY AND THAT WAS UNSUCCESSFUL AS WELL. THAT COIL WAS REMOVED WITHOUT ANY ISSUES. A MICRUSPHERE XL 7MMX14CM COIL (SSR10071420, 30529251) WAS USED AT THIS POINT WITH THE SAME MICROCATHETER IN PLACE. THAT COIL FRACTURED AS WELL DUE TO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19197119 ↗
• MalfunctionMay 24, 2019Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 7MM X 14CM MICRUSPHERE XL 10 COIL (SSR10071420 / P11270) COULD NOT BE ADVANCED INTO THE MICROCATHETER. 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 PRODUCT WAS RETURNED FOR EVALUATION WHICH REVEALED THAT THE 7MM X 14CM MICRUSPHERE XL 10 COIL WAS IN A STRETCHED CONDITION. BASED ON THE PRODUCT ANALYSIS COMPLETED ON 5/24/2019, THIS EVENT HAS BEEN DEEMED MDR REPORTABLE AS A ¿MALFUNCTION.¿

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8642749 ↗
• MalfunctionAug 14, 2018Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A CAROTID-CAVERNOUS FISTULA (CCF), THE 7 MM X 14 CM MICRUSPHERE XL (SSR10071420/S10032) THERMO-MECHANICAL COIL DELIVERY SYSTEM WAS ADVANCED THROUGH THE ECHELON 10 (MEDTRONIC) MICROCATHETER BUT STRONG RESISTANCE WAS ENCOUNTERED AT THE MIDSHAFT OF THE CATHETER. THE COIL DELIVERY SYSTEM BECAME STUCK AND COULD NO LONGER BE ADVANCED. THE COIL WAS REMOVED FROM THE MICROCATHETER. WHEN THE COIL WAS REMOVED, THE EMBOLIC COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM, BUT THE USER NOTED THAT THE EMBOLIC COIL WAS STRETCHED. THE SAME MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE SURGERY WAS NOT DELAYED DUE TO THE EVENT. PRIOR TO THIS COIL, TWO COILS WERE ADVANCED THROUGH THE SAME MICROCATHETER WITHOUT RESISTANCE. THE COIL DELIVERY SYSTEM WAS PREPPED WITHOUT ANY DIFFICULTY. THE USER DID NOT FASTEN THE ROTATING HEMOSTATIC VALVE (RHV) TOO TIGHTLY AROUND THE INTRODUCER. THE USER CONTINUOUSLY VERIFIED THAT THE INTRODUCER TIP AND MICROCATHETER HUB REMAINED ALIGNED. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. WHEN THE UNUSUAL FRICTION O

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7782105 ↗