MICRUSPHERE SPH100600-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00878528003564), received between Oct 17, 2017 and Jul 23, 2018 — 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.

• MalfunctionJul 23, 2018Stretched; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE, THE MICROSPHERE 10 PLATINUM COIL 6MM X 11.9CM (B)(4) WAS FOUND STRETCHED. THE COIL WAS WITHDRAWN AND ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT INJURY OR CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7712910 ↗
• MalfunctionMar 13, 2018Stretched; Stretched

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A MICRUSPHERE 6MM X 11.0CM COIL (SPH10060020/C27844) HAD STRETCHED DURING AN ANEURYSM COILING PROCEDURE. THE PHYSICIAN ADVANCED THE COIL WITHOUT ANY ISSUES, BUT REALIZED IT WAS TOO BIG FOR THE ANEURYSM AND REMOVED IT. WHEN THE COIL WAS REMOVED, THE PHYSICIAN NOTICED THAT PART OF THE COIL WAS STRETCHED AT THE PROXIMAL PORTION. THE PATIENT'S OUTCOME WAS FINE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT'S VESSEL CHARACTERISTICS WERE STANDARD. THERE WAS NO DELAY IN PROCEDURE AS A RESULT OF THE REPORTED EVENT AND NO MEDICAL INTERVENTION WAS REQUIRED TO THE PATIENT. A SCEPTER BALLOON CATHETER XC, 7F 10CM TERUMO SHEATH, 6F ENVOY MPD 100CM, PROWLER SL10, HEADLINER GUIDEWIRE .012, AND A SYNCHRO STANDARD WIRE .014 WERE ALSO USED DURING THE PROCEDURE. THERE WAS NO DAMAGE NOTED TO THE COIL, COIL DELIVERY SYSTEM, OR COIL DETACHMENT SYSTEM PRIOR TO THE PROCEDURE. THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN IT WAS REMOVED FROM THE PATIENT. THERE WERE NO KINKS OR BENDS NOTED TO THE MICROCATHETER THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. IT WAS NOTED THAT THE SCEPTER BALLOON CATHETER XC MAY HAVE HAD A LEAK AS IT WAS N

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7333969 ↗
• MalfunctionOct 17, 2017Stretched; Stretched

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A MICRUSPHERE COIL (SPH10060020/C22165) STRETCHED DURING A PROCEDURE. ANOTHER ONE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6954281 ↗