ORBIT GALAXYRecalls & reported problems across all models

We found 26 models of ORBIT GALAXY by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 225 adverse event reports in the FDA's MAUDE database, received between Sep 13, 2016 and Jul 31, 2026 — classified as 1 death, 24 injuries, 200 malfunctions.

The most frequently reported specific device problem is “Stretched” (55 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported ORBIT GALAXY problems

ORBIT GALAXY models

26 models, most reported first. Each model has its own page with its reports, recalls and device details.

• ORBIT GALAXY 640CR0725

  DEVICE, NEUROVASCULAR EMBOLIZATION
  28 reports
• ORBIT GALAXY 640CF0412

  Device, Vascular, for Promoting Embolization
  25 reports
• ORBIT GALAXY 640CF0515

  Device, Vascular, for Promoting Embolization
  24 reports
• ORBIT GALAXY 640CF0620

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 death20 reports
• ORBIT GALAXY 640CR0830

  Device, Vascular, for Promoting Embolization
  20 reports
• ORBIT GALAXY 640CF0510

  DEVICE, NEUROVASCULAR EMBOLIZATION
  18 reports
• ORBIT GALAXY 640CF0615

  Device, Vascular, for Promoting Embolization
  12 reports
• ORBIT GALAXY 640CR0930

  DEVICE, NEUROVASCULAR EMBOLIZATION
  11 reports
• ORBIT GALAXY 640CF0410

  Device, Vascular, for Promoting Embolization
  10 reports
• ORBIT GALAXY 640CF0721

  DEVICE, NEUROVASCULAR EMBOLIZATION
  9 reports
• ORBIT GALAXY 640CF0824

  DEVICE, NEUROVASCULAR EMBOLIZATION
  8 reports
• ORBIT GALAXY 640CF0925

  Device, Vascular, for Promoting Embolization
  7 reports
• ORBIT GALAXY 640CF0306

  Device, Vascular, for Promoting Embolization
  6 reports
• ORBIT GALAXY 640CF1030

  DEVICE, NEUROVASCULAR EMBOLIZATION
  6 reports
• ORBIT GALAXY 640CR0620

  Device, Vascular, for Promoting Embolization
  6 reports
• ORBIT GALAXY 640CF0308

  Device, Vascular, for Promoting Embolization
  5 reports
• ORBIT GALAXY 640CF0201

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• ORBIT GALAXY 640CF0505

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• ORBIT GALAXY 640CF0610

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• ORBIT GALAXY 640CF0715

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• ORBIT GALAXY 640CF0815

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• ORBIT GALAXY 640CF1230

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• ORBIT GALAXY 640CR1030

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• ORBIT GALAXY 640CR1430

  DEVICE, NEUROVASCULAR EMBOLIZATION
  1 report
• ORBIT GALAXY 640CR1630

  Device, Vascular, for Promoting Embolization
  1 report
• ORBIT GALAXY 640CR2030

  Device, Vascular, for Promoting Embolization
  1 report

Recent ORBIT GALAXY adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJul 31, 2026Separation Failure

  The healthcare professional reported that during an endovascular embolization procedure, the 8mm x 30cm Complex Frame ((b)(4)) was impeded in the introducer sheath and could not be inserted into the associated microcatheter. The physician found that the proximal end of the introducer broke into two pieces; the physician then switched to a second coil to pack the aneurysm and successfully detached. A third coil, 8mm x 15cm Orbit Galaxy Complex Fill ((b)(4)) was used to pack the aneurysm, and it was found that the third coil was unable to be detached. The physician retracted the coil and replaced it with a fourth coil to complete the procedure using the original microcatheter. The procedure was prolonged by about 10 minutes. There was no report of any negative patient impact.On 24-Jul-2026, additional information was received. Per the information, the procedure was targeting the internal carotid artery. The third coil was still attached to the delivery system when it was removed. The syringe was filled with saline from a dedicated source. Before attempting to deploy the third coil, the syringe had previously exceeded the Green Zone/position 3. With the attempt to deploy the third coi

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50100851 ↗
• MalfunctionJun 25, 2026Separation Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, A COMPETITIVE MICROCATHETER (MC) WAS IN PLACE AN ORBIT GALAXY COIL (PRODUCT CODE: 640CF0505, LOT NUMBER: 31204208) WAS DELIVERED TO TARGET SITE. THE COIL WAS PACKED IN THE ANEURYSM AND TRIED TO DETACH, BUT THE COIL WAS UNABLE TO DETACH. THE DOCTOR ONLY RETRACTED THE COIL ALONE AND SWITCHED TO A SECOND COIL, ANOTHER ORBIT GALAXY (PRODUCT CODE: 640CF0510, LOT NUMBER: 31211764) AND TRIED TO DETACH IT, BUT THE SECOND COIL WAS ALSO UNABLE TO DETACH. THE DOCTOR ONLY RETRACTED THE SECOND COIL ALONE AND SWITCHED TO A THIRD COIL TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 24-JUN-2026 INDICATED THAT A PRE-DEPLOYMENT ELECTRICAL TESTING WAS NOT PERFORMED. THE SAME DCB AND CONTROL CABLES WERE NOT USED WITH THE SUBSEQUENT COILS. THE COILS WERE ATTACHED TO THE COIL DELIVERY SYSTEMS WHEN REMOVED FROM THE PATIENT. THE COILS WERE NOT STRETCHED OR DAMAGED WHEN REMOVED FROM THE PATIENT. THERE WAS NO PROCEDURE PROLONGATION/DELAY DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25623147 ↗
• MalfunctionJun 25, 2026Separation Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, A COMPETITIVE MICROCATHETER (MC) WAS IN PLACE AN ORBIT GALAXY COIL (PRODUCT CODE: 640CF0505, LOT NUMBER: 31204208) WAS DELIVERED TO TARGET SITE. THE COIL WAS PACKED IN THE ANEURYSM AND TRIED TO DETACH, BUT THE COIL WAS UNABLE TO DETACH. THE DOCTOR ONLY RETRACTED THE COIL ALONE AND SWITCHED TO A SECOND COIL, ANOTHER ORBIT GALAXY (PRODUCT CODE: 640CF0510, LOT NUMBER: 31211764) AND TRIED TO DETACH IT, BUT THE SECOND COIL WAS ALSO UNABLE TO DETACH. THE DOCTOR ONLY RETRACTED THE SECOND COIL ALONE AND SWITCHED TO A THIRD COIL TO COMPLETE THE SURGERY. THE MICROCATHETER WAS NOT REPLACED. THERE WAS NO PATIENT INJURY REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 24-JUN-2026 INDICATED THAT A PRE-DEPLOYMENT ELECTRICAL TESTING WAS NOT PERFORMED. THE SAME DCB AND CONTROL CABLES WERE NOT USED WITH THE SUBSEQUENT COILS. THE COILS WERE ATTACHED TO THE COIL DELIVERY SYSTEMS WHEN REMOVED FROM THE PATIENT. THE COILS WERE NOT STRETCHED OR DAMAGED WHEN REMOVED FROM THE PATIENT. THERE WAS NO PROCEDURE PROLONGATION/DELAY DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25623086 ↗
• MalfunctionApr 3, 2026Fracture; Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED DURING A PROCEDURE ON (B)(6) 2026, THE 7MM X 25CM ORBIT GALAXY COMPLEX FRAME COIL (640CR0725 / 31557207) ENCOUNTERED A LOT OF RESISTANCE DURING ITS DEPLOYMENT. THE PUSHER WIRE BROKE WHILE THE COIL WAS BEING PUSHED. THE COIL WAS REMOVED AND REPLACED WITH A NEW COIL OF A DIFFERENT SIZE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY DELAY AND WITHOUT ANY NEGATIVE IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24780971 ↗
• MalfunctionApr 2, 2026Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED ENDOVASCULAR EMBOLIZATION PROCEDURE ON (B)(6) 2026, THE MICROCATHETER WAS IN PLACE AND THE 8MM X 24CM ORBIT GALAXY COMPLEX FILL (640CF0824 / 31651278) WAS DELIVERED TO THE TARGET SITE. THE COIL FILLED THE ANEURYSM, AND THE PHYSICIAN TRIED TO DETACH THE COIL, BUT THE COIL WAS UNABLE TO BE DETACHED. THE PHYSICIAN RETRACTED ONLY THE COIL AND REPLACED IT WITH A SECOND COIL, A 2.5MM X 5CM ORBIT GALAXY COMPLEX XTRASOFT (640CX2505 / 31661861). THE SECOND COIL ENCOUNTERED THE SAME ISSUE; IT WAS UNABLE TO BE DETACHED. THE PHYSICIAN RETRACTED THE COIL AND REPLACED IT WITH A THIRD COIL FROM ANOTHER MANUFACTURER TO COMPLETE THE PROCEDURE USING THE ORIGINAL MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE IMPACT ON THE PATIENT. ON (B)(6) 2026, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PROCEDURE WAS A STENT-ASSISTED COIL EMBOLIZATION OF AN ANEURYSM ON THE INTERNAL CAROTID ARTERY. THE COILS WERE NOT STRETCHED WHEN THEY WERE REMOVED; THEY WERE STILL ATTACHED TO THE DELIVERY SYSTEMS. THERE WAS NO INTERRUPTION OF BLOOD FLOW. THE SYRINGE WAS FILLED WITH SALINE FROM A DEDICATED SOURCE. THE SAME SYRINGE WAS USED WIT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24767327 ↗
• MalfunctionMar 30, 2026Crack

  A HEALTHCARE PROFESSIONAL REPORTED THAT THE SHAFT OF AN ORBIT GALAXY (PRODUCT CODE: 640CF0510, LOT NUMBER: UNKNOWN) BROKE. THERE WAS NO PATIENT INJURIES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24714309 ↗
• MalfunctionMar 23, 2026Separation Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION, A MICROCATHETER (COMPETITOR¿S BRAND) WAS IN PLACE AND AN ORBIT GALAXY COIL (PRODUCT CODE: 640CF0615, LOT NUMBER: 31638655) WAS DELIVERED TO THE TARGET SITE. THE COIL WAS DEPLOYED WITHIN THE ANEURYSM. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL; HOWEVER, THE COIL DID NOT DETACH. THE PHYSICIAN RETRACTED ONLY THE COIL AND REPLACED IT WITH A NEW COIL TO COMPLETE THE PROCEDURE. THE MICROCATHETER (MC) WAS NOT REPLACED. NO PATIENT INJURY WAS REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 17-MAR-2026 INDICATED THAT A TRUFILL DCS SYRINGE WAS USED. THE SAME SYRINGE WAS USED TO DETACH SUBSEQUENT COILS. THE SAME SYRINGE DID NOT PREVIOUSLY EXCEEDED THE GREEN ZONE/POSITION 3. AFTER THE COIL DID NOT DETACH AT THE SYRINGE GREEN ZONE, IT WAS ATTEMPTED TO DEPLOY THE COIL AT THE SYRINGE RED ALTERNATIVE DETACHMENT ZONE. PRIOR TO ATTEMPTING TO DETACH, IT WAS VERIFIED UNDER FLUORO THAT THERE WAS NO STRESS AGAINST THE MICROCATHETER OR DELIVERY TUBE. THE SYRINGE PRESSURIZED AS INTENDED. THERE WAS NO NECK REMODELING UTILIZED. IT WAS NOT NECESSARY TO REMOVE THE MICROCATHETER. THE COIL WAS STILL ATTACHED TO THE COIL DELIVERY SYSTEM WHEN R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24664590 ↗
• MalfunctionFeb 10, 2026Stretched; Separation Failure

  DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE ON (B)(6) 2025, THE MICROCATHETER (UNSPECIFIED BRAND) WAS IN PLACE AND THE 8MM X 24CM ORBIT GALAXY COMPLEX FILL (640CF0824 / 31234521) WAS DELIVERED TO THE TARGET SITE. THE COIL FILLED THE ANEURYSM, AND THE PHYSICIAN TRIED TO DETACH THE COIL, BUT THE COIL WAS UNABLE TO BE DETACHED. THE PHYSICIAN RETRACTED THE COIL AND REPLACED IT WITH A SECOND COIL, A 6MM X 10CM ORBIT GALAXY COMPLEX FILL (640CF0610 / 31226101). THE SECOND COIL ENCOUNTERED THE SAME ISSUE; UNABLE TO BE DETACHED. THE PHYSICIAN RETRACTED THE SECOND COIL AND REPLACED IT WITH A THIRD COIL FROM ANOTHER MANUFACTURER AND COMPLETED THE PROCEDURE USING THE ORIGINAL MICROCATHETER. THE PROCEDURE WAS PROLONGED BY ABOUT 15 MINUTES. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 09-FEB-2026, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE TARGET VESSEL OF THE PROCEDURE WAS THE POSTERIOR CEREBRAL ARTERY. PER THE INFORMATION, BOTH COILS WERE STRETCHED WHEN THEY WERE REMOVED; BOTH WERE STILL ATTACHED TO THE DELIVERY SYSTEMS. THERE WAS NO EVIDENCE OF OBSTRUCTED / REDUCTION OF BLOOD FLOW DUE TO THE REPORTED ISSUE. THE SYRINGE WAS FILLED WITH SALINE FROM A DED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24306510 ↗
• MalfunctionFeb 10, 2026Stretched; Separation Failure

  DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE ON (B)(6) 2025, THE MICROCATHETER (UNSPECIFIED BRAND) WAS IN PLACE AND THE 8MM X 24CM ORBIT GALAXY COMPLEX FILL (640CF0824 / 31234521) WAS DELIVERED TO THE TARGET SITE. THE COIL FILLED THE ANEURYSM, AND THE PHYSICIAN TRIED TO DETACH THE COIL, BUT THE COIL WAS UNABLE TO BE DETACHED. THE PHYSICIAN RETRACTED THE COIL AND REPLACED IT WITH A SECOND COIL, A 6MM X 10CM ORBIT GALAXY COMPLEX FILL (640CF0610 / 31226101). THE SECOND COIL ENCOUNTERED THE SAME ISSUE; UNABLE TO BE DETACHED. THE PHYSICIAN RETRACTED THE SECOND COIL AND REPLACED IT WITH A THIRD COIL FROM ANOTHER MANUFACTURER AND COMPLETED THE PROCEDURE USING THE ORIGINAL MICROCATHETER. THE PROCEDURE WAS PROLONGED BY ABOUT 15 MINUTES. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON (B)(6) 2026, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE TARGET VESSEL OF THE PROCEDURE WAS THE POSTERIOR CEREBRAL ARTERY. PER THE INFORMATION, BOTH COILS WERE STRETCHED WHEN THEY WERE REMOVED; BOTH WERE STILL ATTACHED TO THE DELIVERY SYSTEMS. THERE WAS NO EVIDENCE OF OBSTRUCTED / REDUCTION OF BLOOD FLOW DUE TO THE REPORTED ISSUE. THE SYRINGE WAS FILLED WITH SALINE FROM A DED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24306504 ↗
• MalfunctionFeb 5, 2026Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION, THE PHYSICIAN ATTEMPTED TO ADVANCE A ORBIT GALAXY COIL (PRODUCT CODE: 640CF0510, LOT NUMBER: 31606031) THROUGH A MICROCATHETER (NON COMPANY BRAND). THE COIL BECAME IMPEDED AT THE PROXIMAL END OF THE MICROCATHETER (MC) AND COULD NOT BE ADVANCED FURTHER. THE PHYSICIAN THEN RETRACTED THE COIL WITHOUT RESISTANCE, REMOVED IT FROM THE SYSTEM, AND REPLACED IT WITH A NEW COIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE REPLACEMENT COIL. THE MICROCATHETER REMAINED IN USE AND WAS NOT EXCHANGED. NO PATIENT INJURY OR ADVERSE CLINICAL IMPACT WAS REPORTED. ADDITIONAL EVENT INFORMATION RECEIVED ON 04-JAN-2026 INDICATED THAT THE EVENT DID NOT RESULT IN ANY UNDUE PROCEDURAL DELAY THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT. THE MICROCATHETER WAS A SL-10. A SYNCHRO MICRO GUIDE WIRE WAS SUCCESSFULLY USED WITH THE MICROCATHETER PRIOR TO OR AFTER THE ENCOUNTERED RESISTANCE. THE TARGET VESSEL WAS THE C7 SEGMENT (COMMUNICATING SEGMENT) OF THE INTERNAL CAROTID ARTERY. THE VESSEL WAS RELATIVELY TORTUOUS. THE DEVICE DID NOT APPEAR DAMAGED AT ANY TIME. A CONTINUOUS FLUSH WAS MAINTAINED. THE TIP OF THE INTRODUCER WAS FIRMLY INSTAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24269323 ↗
• MalfunctionFeb 2, 2026Stretched; Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT THIS WAS A COIL EMBOLIZATION, AFTER AN ORBIT GALAXY COIL (PRODUCT CODE: 640CR0725, LOT NUMBER: 31540290) PARTIALLY PASSED A NON-J&J MICROCATHETER, THE COIL WAS IMPEDED IN THE MICROCATHETER TIP AND COULD NOT ADVANCE ANY MORE. THE DOCTOR REMOVED THE COIL AND MICROCATHETER (MC) FROM THE PATIENT AND FOUND THE COIL WAS UNRAVELED/STRETCHED. THE DOCTOR SWITCHED TO A NEW COIL TO COMPLETE THE SURGERY WITH THE ORIGINAL MICROCATHETER. THE SURGERY WAS PROLONGED BY ABOUT 10 MINUTES. IT WAS REPORTED THAT BEFORE THE PROCEDURE, THE DEVICE OUTER PACKAGING AND THE DEVICE WERE INSPECTED AND FOUND IN GOOD CONDITION. ADDITIONAL EVENT INFORMATION RECEIVED ON 02-FEB-2026 INDICATED THAT THEY WERE ABLE TO TORQUE THE DEVICE. THERE WAS NO EVIDENCE OF PHYSICAL MATERIAL WITHIN THE DEVICE. A SL-10 MICROCATHETER WAS USED. THE MICROCATHETER DID NOT KINK/BENT. THERE WAS NO EXCESSIVE FORCE USED WITH THE DEVICES. THE 10 MINIUTES PROCEDURAL DELAY DID NOT RESULT IN A PATIENT ADVERSE CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24240241 ↗
• MalfunctionJan 28, 2026Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION, A 12X30 ORBIT GALAXY COIL (PRODUCT CODE 640CF1230, LOT NUMBER 31613399) WAS DELIVERED TO TARGET SITE. THE COIL WAS FILLED IN THE ANEURYSM AND TRIED TO DETACH, BUT THE COIL WAS UNABLE TO DETACH. THE DOCTOR ONLY RETRACTED THE COIL ALONE AND SWITCHED A NEW ONE TO COMPLETE THE SURGERY. THE NON J&J MICROCATHETER (MC) WAS NOT REPLACED. ADDITIONAL EVENT INFORMATION RECEIVED ON 15-JAN-2026 INDICATED THAT THE SYRINGE USED WAS A JOHNSON & JOHNSON PRODUCT. THE SAME SYRINGE WAS USED TO DETACH SUBSEQUENT COILS. THE SAME SYRINGE WAS PREVIOUSLY EXCEEDED THE GREEN ZONE/POSITION 3. AFTER THE COIL DID NOT DETACH AT THE SYRINGE GREEN ZONE, IT WAS ATTEMPTED TO DEPLOY THE COIL AT THE SYRINGE RED ALTERNATIVE DETACHMENT ZONE. PRIOR TO ATTEMPTING TO DETACH, IT WAS VERIFIED UNDER FLUORO THAT THERE WAS NO STRESS AGAINST THE MICROCATHETER OR DELIVERY TUBE. THE SYRINGE PRESSURIZED AS INTENDED. NECK REMODELING WAS UTILIZED WITH A STENT. THE COIL WAS STILL ATTACHED TO THE COIL DELIVERY SYSTEM WHEN REMOVED FROM THE PATIENT. THERE WERE NO PROCEDURE DELAYS/PROLONGATION DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24199347 ↗
• MalfunctionJan 20, 2026Failure to Advance

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION, AN ORBIT GALAXY COIL (PRODUCT CODE: 640CR0930, LOT NUMBER: 31359782) WAS IMPEDED IN THE INTRODUCER AND COULD NOT BE PUSHED INTO A NON-J&J MICROCATHETER (MC). THE PHYSICIAN ONLY RETRACTED THE COIL ALONE AND SWITCHED TO A NEW NON-J&J COIL TO COMPLETE THE PROCEDURE. THE MICROCATHETER WAS NOT REPLACED. NO PATIENT INJURIES NOR CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE EVENT DID NOT RESULT IN ANY UNDUE PROCEDURAL DELAY THAT COULD BE CONSIDERED CLINICALLY SIGNIFICANT. A RUIKANGTONG 17 SYSTEM MICROCATHETER WAS USED. THE DEVICES DID NOT APPEAR PHYSICALLY DAMAGED AT ANY TIME. NOTHING WAS NOTED TO BE OBSTRUCTING THE INTRODUCER. A CONTINUOUS FLUSH WAS MAINTAINED. BASED ON THE PRODUCT ANALYSIS OF THE DEVICE RECEIVED, THE COIL IS NOTED TO BE MECHANICALLY DETACHED FROM THE DELIVERY SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24121371 ↗
• MalfunctionJan 13, 2026Difficult to Advance

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PROCEDURE, THE 5MM X 15CM ORBIT GALAXY COMPLEX FILL COIL (640CF0515/31613390) ENCOUNTERED A LOT OF RESISTANCE AND BECAME BENT AND THE DELIVERY WIRE ¿GOT BROKEN.¿ IT WAS ALSO REPORTED THAT THE 10MM X 30CM ORBIT GALAXY COMPLEX FILL COIL (640CF1030/31467308) ENCOUNTERED RESISTANCE DURING THE COIL ADVANCEMENT. THE 132CM EMBOVAC 71 ASPIRATION CATHETER (IC71132CA/31411520) GOT STUCK IN THE HOOP. THE PROCEDURE WAS DELAYED BY 15 MINUTES. IT WAS SUCCESSFULLY COMPLETED BY USING ¿ANOTHER CATHETER AND COILS.¿ THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. BASED ON THE EVENT DESCRIPTION, THE ISSUE REPORTED WITH THE 5MM X 15CM ORBIT GALAXY COMPLEX FILL COIL (640CF0515/31613390) MEETS USFDA REPORTING CRITERIA A CLASSIFICATION OF ¿MALFUNCTION.¿ THE COMPLAINT DEVICES WERE RETURNED FOR EVALUATION AND ANALYSIS. BASED ON THE RESULT OF THE PRODUCT ANALYSIS COMPLETED ON 09-JAN-2026, THE REPORTED ISSUE RELATED TO THE 10MM X 30CM ORBIT GALAXY COMPLEX FILL COIL (640CF1030/31467308) MEETS USFDA REPORTING CRITERIA UNDER 21 CFR 803 AS A "MALFUNCTION."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24063816 ↗
• MalfunctionDec 18, 2025Break; Break

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR EMBOLIZATION PROCEDURE, THE 5MM X 15CM ORBIT GALAXY COMPLEX FILL COIL (640CF0515 / 31748453) WAS USED AND THE COIL HYPO TUBE BROKE. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY NEGATIVE PATIENT IMPACT AND WITHOUT ANY DELAY IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23846296 ↗

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