ORBIT GALAXY ENPOWER XTRASOFT 641CX0306Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10878528008948), received between May 17, 2017 and Jan 24, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Stretched” (5 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 18, 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.

• MalfunctionJan 24, 2022Stretched; Stretched

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 3X6 ORBIT GALAXY ENPOWER XTRASOFT COIL (641CX0306, UNKNOWN LOT) BECAME STRETCHED INSIDE THE UNSPECIFIED MICROCATHETER (MC) WHILE DEPLOYING IN THE ANEURYSM. THE SURGERY WAS DELAYED DUE TO THE REPORTED EVENT BY 10 MINUTES. THE MICROCATHETER WAS REMOVED FROM THE SITE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13333224 ↗
• MalfunctionAug 19, 2019Stretched; Premature Separation; Stretched; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE, THE 3MM X 6CM G2 STRETCH RESISTANT COMPLEX XTRASOFT COIL (641CX0306 / S14414) BECAME PREMATURELY DETACHED WITHIN THE PROWLER SELECT LPES MICROCATHETER. THE PHYSICIAN WAS ABLE TO REMOVE BOTH THE COIL AND THE MICROCATHETER FROM THE PATIENT¿S ARTERY WITHOUT CAUSING ANY DAMAGE. THE REPORTED EVENT DID RESULT IN A 15-MINUTE DELAY; THE PROCEDURE WAS REPORTED AS SUCCESSFULLY COMPLETED WITHOUT ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8908466 ↗
• MalfunctionOct 30, 2018Stretched; Premature Separation; Stretched; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PROCEDURE WHILE THE G2 STRETCH RESISTANT COMPLEX XTRASOFT COIL 3MM X 6CM (641CX0306 / P11685) WAS BEING ADVANCED THROUGH THE MICROCATHETER, THE COIL WAS MET WITH GREAT RESISTANCE. WHEN THE COIL WAS REMOVED, IT WAS STRETCHED. ANOTHER COIL WAS USED TO CONTINUE WITH THE PROCEDURE. THERE WAS NO REPORT OF ANY PATIENT CONSEQUENCE OR ADVERSE EVENT ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8020048 ↗
• MalfunctionMay 2, 2018Stretched; Physical Resistance; Stretched; Physical Resistance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION AN ANTERIOR COMMUNICATING ARTERY ANEURYSM, THE PHYSICIAN ENCOUNTERED STRONG RESISTANCE WHILE PUSHING THE 3X6 G2 COMPLEX XTRASOFT (641CX0306/P10435) THERMO-MECHANICAL COIL DELIVERY SYSTEM THROUGH THE MIDSHAFT OF THE ECHELON 10 (MEDTRONIC) MICROCATHETER. THE COIL GOT STUCK AND COULD NO LONGER ADVANCE. THE ISSUE REQUIRED THAT THE COIL AND MICROCATHETER BE REMOVED AS A UNIT. THE COIL WAS NOTED TO BE STRETCHED UPON REMOVAL FROM THE MICROCATHETER. THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN REMOVED FROM THE MICROCATHETER. THE COIL WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORT OF CONSEQUENCE OR IMPACT TO THE PATIENT. THE SURGERY WAS DELAYED 10 MINUTES DUE TO THE EVENT. NO VISIBLE PRODUCT DAMAGE WAS NOTED PRIOR TO THE EVENT. THE COIL WAS PREPPED AND HANDLED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) GUIDELINES. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THERE WAS NO RESISTANCE ENCOUNTERED BETWEEN THE GUIDEWIRE AND THE MICROCATHETER WHEN ACCESSING THE TARGET SITE. PRIOR TO THIS COIL, TWO COILS WENT THROUGH THE SAME MICROCATHETER WITHOUT RESISTANCE. T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7479167 ↗
• MalfunctionMay 17, 2017Stretched; Stretched

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A G2 CMPLX XS COIL (641CX0306/P11684) GOT STUCK IN THE MID PORTION OF THE MICROCATHETER (ECHELON 10, MEDTRONIC PRODUCT) AND FOUND TO BE STRETCHED WHEN IT WAS REMOVED FROM THE MICROCATHETER DURING AN ICA TERMINUS ANEURYSM COILING PROCEDURE. THE COIL WAS STILL ATTACHED TO THE DELIVERY SYSTEM WHEN IT WAS REMOVED FROM THE PATIENT. REPORTEDLY, A GALAXY G2 COIL 2.5X3.5 WAS SUCCESSFULLY USED WITH THE MICROCATHETER PRIOR TO THIS EVENT. ONLY THE G2 CMPLX XS COIL (COMPLAINT PRODUCT) WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS DELAYED ABOUT 10 MINUTES AND WAS COMPLETED WITH OTHER COILS. THE PATIENT¿S STATUS POST PROCEDURE WAS WELL. THE PATIENT WAS A (B)(6) MALE; THE ANEURYSM WAS 2.8 WIDE, 2.2 LONG, WITH A 1.6 NECK. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, NOR WAS ANY ADDITIONAL INTERVENTION REQUIRED. AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE CATHETER. THE DEVICE IS BEING RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6573307 ↗