MICRUSPHERE SSR181540-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00878528009986), received between Dec 21, 2016 and May 16, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Detachment Of Device Component” (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.

• MalfunctionMay 16, 2022Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE ON A MALE PATIENT, THE MICROSPHERE XL 15MM X 40CM COIL (SSR18154020, L14750) PRESENTED TECHNICAL PROBLEMS AND THERE WAS NO PROGRESSION WITHIN THE MICROCATHETER, MAKING ITS USE IMPOSSIBLE FOR THE TREATMENT OF THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL WAS FOUND STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14408476 ↗
• MalfunctionAug 8, 2018Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF AN ANTERIOR COMMUNICATING ARTERY ANEURYSM, STRONG RESISTANCE WAS ENCOUNTERED WHILE INSERTING THE 15 MM X 40 CM MICRUSPHERE XL (SSR18154020/S12632) THERMO-MECHANICAL COIL INTO THE PROWLER LPES MICROCATHETER (UNK CATALOG AND LOT) AND THE EMBOLIC COIL STRETCHED PRIOR TO DEPLOYMENT. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE MICRUSPHERE COIL WILL BE RETURNED FOR EVALUATION. IT WAS NOT REPORTED WHETHER THE PROWLER MICROCATHETER WOULD BE RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7763745 ↗
• MalfunctionMar 10, 2017Premature Activation; Physical Resistance; Premature Activation; Physical Resistance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, A MICRUSPHERE XL COIL (SSR18154020/ P10990) COULD NOT BE PUSHED INTO THE UNSPECIFIED MICROCATHETER. INFORMATION FROM THE PRODUCT ANALYSIS ON 3/2/2017 REVEALED THAT THE COIL WAS MECHANICALLY DETACHED FROM THE DEVICE POSITION UNIT (DPU).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6394848 ↗
• MalfunctionDec 21, 2016Detachment Of Device Component; Device Operates Differently Than Expected; Detachment Of Device Component; Device Operates Differently Than Expected

  IT WAS REPORTED BY THE CONTACT AT THE USER FACILITY THAT DURING A COIL EMBOLIZATION PROCEDURE THE FIRST COIL USED A MICRUSPHERE XL 15MM X 40 CM ((B)(4)) COIL COULD NOT BE DETECTED BY THE DETACHMENT BOX. THE GREEN LED LIGHT DID NOT ILLUMINATE WHEN THE CONNECTING CABLE WAS CONNECTED TO THE HUB OF THE COIL. ALL THE CONNECTIONS WERE CHECKED AFTER WHICH THE CONNECTING CABLE WAS CHANGED, HOWEVER THE LIGHT STILL DID NOT ILLUMINATE. A PRE-DEPLOYMENT ELECTRICAL CHECK WAS NOT PERFORMED WITH THE COMPLAINT COIL. THE COMPLAINT COIL WAS REMOVED AND WAS STILL ATTACHED TO THE DELIVERY SYSTEM; NO DAMAGES WERE NOTED ON THE COMPLAINT COIL. A NEW COIL WAS USED INSTEAD. THREE COILS WERE THEN USED WITHOUT ISSUES. PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED WITH ALL THE COILS USED AFTER THE COMPLAINT COIL. THE SAME CONNECTING CABLE AND DETACHMENT CONTROL BOX WAS USED WITH THE SUBSEQUENT COILS. THERE WERE NO INTRA OR POST PROCEDURAL COMPLICATIONS OR SURGICAL DELAYS RELATED TO DEVICE OR REPORTED EVENT. THE PROCEDURE WAS COIL EMBOLIZATION OF A PARTIALLY THROMBOSED GIANT TOP INTERNAL CAROTID ARTERY ANEURYSM IN A (B)(6) YEAR OLD FEMALE PATIENT WHOSE VESSELS WERE SEVERELY TORTUOUS. IT WAS INITIALLY REPORTED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6192658 ↗