MICRUSPHERE SSR100620-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00878528009955), received between Dec 7, 2017 and Nov 28, 2022 — classified as 1 injury, 4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 28, 2022Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE WITH THE BASILAR ARTERY AS THE PARENT VESSEL, THERE WERE ISSUES DETACHING TWO (2) SEPARATE COILS, A 6MM X 20CM MICRUSPHERE XL 10 (SSR10062020 / 30397660) AND A 5MM X 12CM CASHMERE 14 (SRC14051220 / 30422249) WITH THE ENPOWER CONTROL CABLE (ECB00018200 / 30798739). IT WAS REPORTED THAT THE COIL WAS PARTIALLY DETACHED DURING THE INITIAL CYCLE OF THE ENPOWER CABLE AND BOX. WHEN THE PHYSICIAN PULLED BACK ON THE DELIVERY WIRE, A PORTION OF THE COIL WAS PULLED BACK INTO THE PARENT VESSEL. BOTH TIMES, THE PORTION OF THE COIL WAS PUSHED BACK INTO THE ANEURYSM AND ANOTHER DETACHMENT CYCLE OF THE CABLE WAS PERFORMED SUCCESSFULLY. AFTER THE SECOND OCCURRENCE WITH THE DETACHMENT ISSUE, THE ENPOWER CABLE WAS REPLACED WITH A NEW ONE AND THE REST OF THE COILS USED WAS UNEVENTFUL. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15875016 ↗
• MalfunctionNov 20, 2020Fracture; Stretched; Fracture; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE THE PUSHER WIRE OF THE 6MM X 20CM MICRUSPHERE XL 10 STRETCH RESISTANT COIL (SSR10062020 / K10209) WOULD NOT ADVANCE THROUGH THE ROTATING HEMOSTASIS VALVE (RHV) INTO THE HUB OF THE CONCOMITANT MICROCATHETER (BRAND UNKNOWN). THE INTRODUCER SHEATH WAS INSERTED INTO THE HUB OF THE MICROCATHETER CORRECTLY. AS THE PHYSICIAN WAS PUSHING THE COIL FORWARD, THE WIRE HERNIATED THROUGH THE INTRODUCER SHEATH. THE COIL WAS REMOVED FROM THE RHV AND ANOTHER COIL OF DIFFERENT SIZE AND TYPE WAS USED WITHOUT ANY SIGNIFICANT DIFFICULTY. THE POSITION OF THE MICROCATHETER REMAINED INSIDE THE ANEURYSM. THE SAME MICROCATHETER WAS USED DURING THE ENTIRE CASE. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT OUTCOME AND THERE WAS NO SIGNIFICANT DELAY IN THE ANEURYSM TREATMENT PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE CAUSE OF THE RESISTANCE WAS NOT KNOWN. THE COMPLAINT DEVICE DID NOT APPEAR TO HAVE DAMAGE WHEN IT WAS REMOVED FROM THE PACKAGE. THERE WAS NOTHING NOTED TO BE OBSTRUCTING THE MICROCATHETER. PRIOR TO THE ISSUE ENCOUNTERED WITH THE COMPLAINT COIL, TWO OTHER COILS (A 6MMX12CM MICRUSPHERE XL 10 STRETCH RESISTANT COIL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10880756 ↗
• MalfunctionApr 6, 2018Kinked; Premature Activation; Stretched; Kinked; Premature Activation; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE OF THE DISTAL ANTERIOR CEREBRAL ARTERY ANEURYSM, THE PHYSICIAN LOADED THE MICROSPHERE XL 6MM X 20CM COIL (SSR10062020 / S13730) INTO THE PROWLER MICROCATHETER AND DEPLOYED TWO LOOPS INSIDE THE ANEURYSM BUT WITHDREW THE COIL FOR RE-DEPLOYMENT DUE TO THE UNSATISFACTORY POSITION IN THE ANEURYSM. THE PHYSICIAN ATTEMPTED TO RE-DEPLOY THE COIL BUT FOUND THAT THE COIL HAD DETACHED IN THE MICROCATHETER WHEN IT WAS BEING WITHDRAWN. THE MICROCATHETER WAS REMOVED; ANOTHER MICROCATHETER AND ANOTHER COIL WAS USED. THERE WAS NO REPORT OF PATIENT INJURY OR ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7404163 ↗
• InjuryJan 5, 2018Positioning Failure; Positioning Failure

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A MICRUSPHERE XL COIL (B)(4) WAS USED DURING A COIL EMBOLIZATION PROCEDURE AND THE COIL COULD NOT BE DETACHED. AFTER POSITIONING THE COIL IN THE ANEURYSM, SEVERAL ATTEMPTS WERE MADE TO RELEASE THE COIL, BUT WERE UNSUCCESSFUL. THE CABLES WERE EXCHANGED THREE TIMES, HOWEVER, THE ISSUE WAS NOT RESOLVED. THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THE COIL AND REPLACE IT WITH ANOTHER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7169187 ↗
• MalfunctionDec 7, 2017Kinked; Premature Activation; Stretched; Kinked; Premature Activation; Stretched

  AT A HEALTHCARE FACILITY, A USED MICRUSPHERE XL COIL (SSR10062020/ C31091) WAS FOUND ON THE SHELF AND HAD BEEN SITTING THERE FOR UP TO A YEAR; HOWEVER, THE FACILITY DID NOT KNOW WHAT THE ACTUAL COMPLAINT HAD BEEN. DURING PRODUCT ANALYSIS, IT WAS FOUND THAT THE COIL WAS STRETCHED, DETACHED AND KINKED. THE SALES REPRESENTATIVE INFORMED THE CUSTOMER ABOUT THE IMPORTANCE OF REPORTING ANY COMPLAINTS AS SOON AS POSSIBLE TO JOHNSON AND JOHNSON. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7094924 ↗