MICRUSPHERE SSR100720-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00878528009924), received between Oct 3, 2016 and Oct 30, 2018 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Difficult To Position” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2018Material Deformation; Material Deformation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN ANTERIOR COMMUNICATING ARTERY ANEURYSM, THE USER ENCOUNTERED RESISTANCE WHILE ADVANCING THE 6MM X 26CM PRESIDIO 10 CERE (PC410062630/C35483), 7MM X 30CM PRESIDIO 10 CERE (PC410073030/S10163), AND THE 7MM X 20CM MICRUSPHERE XL (SSR10072020/S13782) THROUGH THE PROXIMAL SHAFT OF THE PROWLER SELECT PLUS (606S255X/17674174) MICROCATHETER. THE ISSUE REQUIRED THAT THE COILS BE REMOVED AND REPLACED. THE SAME MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE PROCEDURAL DELAY WAS LESS THAN 30 MINUTES. THE DEVICES WERE PREPPED AND USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. NO VISIBLE PRODUCT DAMAGE WAS NOTED PRIOR TO THE EVENT. THE CONCOMITANT MICROCATHETER DID NOT KINK OR BEND AT ANY TIME. A 10MM X 34CM PRESIDIO COIL AND COMPETITOR COILS WERE USED SUCCESSFULLY WITH THE CONCOMITANT MICROCATHETER PRIOR TO AND FOLLOWING THE ENCOUNTERED RESISTANCE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE DISTAL PORTION OF THE 6MM X 26CM PRESIDIO EMBOLIC COIL WAS KINKED, THE DISTAL PORTION

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8019899 ↗
• MalfunctionAug 15, 2017Difficult To Position; Physical Resistance; Material Protrusion/Extrusion; Difficult To Position; Physical Resistance; Material Protrusion/Extrusion

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF AN ANTERIOR COMMUNICATING ARTERY ANEURYSM, THE MICROSPHERE XL (SSR10072020/ S10848) KICKED BACK THE ECHELON 10 CATHETER (INNER DIAMETER 0.017) AND PROTRUDED INTO THE PARENT VESSEL DURING DEPLOYMENT OF THE LAST LOOP, AND WHEN ATTEMPTING TO RE-DEPLOY THE COIL, IT COULD NOT ENTER THE MICROCATHETER HUB DUE TO STIFF RESISTANCE. THERE HAD NOT BEEN RESISTANCE WHEN THE COIL WAS INITIALLY IMPLANTED AND WITHDRAWN FROM THE MICROCATHETER. THE PHYSICIAN REMOVED THE COIL AND DEPLOYED A COMPETITOR COIL TO COMPLETE THE PROCEDURE USING THE SAME MICROCATHETER. A CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. THERE WAS NO PATIENT INJURY OR PROCEDURE DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6794212 ↗
• MalfunctionJan 16, 2017Positioning Failure; Positioning Failure

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A MICRUSPHERE XL 7MMX20CM (SSR10072020/LOT UNK) FAILED TO DETACH DURING AN ANEURYSM COILING PROCEDURE. THE DOCTOR TRIED TO DEPLOY THE MICRUSPHERE XL 7MMX20CM (COMPLAINT PRODUCT) THROUGH THE MICROCATHETER AND AFTER DEPLOYING THE COIL, ATTACHED THE CONNECTING CABLE AND PRESSED THE DETACHMENT BUTTON; HOWEVER, THE COIL DID NOT DETACH AFTER 5 ATTEMPTS. THE COIL WAS STILL ATTACHED FROM THE DELIVERY SYSTEM WHEN IT WAS REMOVED FROM THE PATIENT. THERE WAS NO CHANGE TO THE PATIENT'S BLOOD FLOW AND NO CHANGE IN THE PATIENT'S CONDITION. REPORTEDLY, THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. PREVIOUSLY, DURING THE SAME CASE, THE DOCTOR DEPLOYED A MICRUSPHERE 15 MMX40 CM AND IT DETACHED PERFECTLY WITH THE SAME CABLE AND DETACHMENT BOX. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY DEPLOYING TWO MORE MEDTRONIC AXIOM COILS. THE DEVICE IS BEING RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6253584 ↗
• MalfunctionOct 3, 2016Material Separation; Failure to Advance; Material Separation; Failure to Advance

  THE CONTACT FROM THE FACILITY REPORTED THAT THE MICRUSPHERE COIL (SSR10072020/C28801) COIL GOT STUCK IN THE PROXIMAL SHAFT OF THE ECHELON 10 MICROCATHETER (DETAILS UNKNOWN.) THE DEVICE WAS REMOVED WITHOUT REMOVING THE MICROCATHETER. THE DEVICE DID NOT KINK OR BEND AT ANY TIME PRIOR TO THE RESISTANCE/FRICTION. THE MICROCATHETER DID NOT KINK OR BEND AT ANY TIME. THERE WERE NO DAMAGES TO THE DEVICE WHEN IT WAS REMOVED FROM THE PATIENT. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE CATHETER. AXIUM COILS (DETAILS UNKNOWN) WERE ADVANCED THROUGH THE MICROCATHETER PRIOR TO THE MICRUSPHERE COIL BECOMING STUCK. THERE WAS NO SIGNIFICANT CLINICAL DELAY TO THE PROCEDURE AS A RESULT OF THE ISSUE. THE PROCEDURE WAS CONTINUED WITH OTHER COMPETITOR PRODUCTS (DETAILS UNKNOWN.) FAILURE ANALYSIS LATER DISCOVERED THAT THE RETURNED COIL WAS STRETCHED AND SEVERED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5994455 ↗