MReyeRecalls & reported problems across all models
Cook Incorporated · 13 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 21
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls
- 0
We found 13 models of MReye by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 21 adverse event reports in the FDA's MAUDE database, received between May 18, 2016 and May 8, 2024 — classified as 9 injuries, 12 malfunctions.
The most frequently reported specific device problem is “Material Separation” (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. 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
Reports received per month, all models
Most reported MReye problems
Device problems
- Adverse Event Without Identified Device or Use Problem7
- Material Separation5
- Stretched4
- Difficult to Advance3
- Entrapment of Device3
- Improper or Incorrect Procedure or Method2
- Migration2
- Activation, Positioning or Separation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- No Known Impact Or Consequence To Patient6
- Foreign Body Reaction5
- No Code Available2
- Swelling/ Edema2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Chest Pain1
- Embolism/Embolus1
MReye models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MReye G42408Device, Vascular, for Promoting Embolization3 reports
- MReye G42423Device, Vascular, for Promoting Embolization3 reports
- MReye G20055Device, Vascular, for Promoting Embolization2 reports
- MReye G20098Device, Vascular, for Promoting Embolization2 reports
- MReye G20948Device, Vascular, for Promoting Embolization2 reports
- MReye G42454Device, Vascular, for Promoting Embolization2 reports
- MReye G19908Device, Vascular, for Promoting Embolization1 report
- MReye G19949Device, Vascular, for Promoting Embolization1 report
- MReye G20151Device, Vascular, for Promoting Embolization1 report
- MReye G20291Device, Vascular, for Promoting Embolization1 report
- MReye G42409Device, Vascular, for Promoting Embolization1 report
- MReye G42414Device, Vascular, for Promoting Embolization1 report
- MReye G42419Device, Vascular, for Promoting Embolization1 report
Recent MReye adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 8, 2024Material Separation; Unraveled Material; Material Separation; Unraveled Material
IT WAS REPORTED THAT A MREYE EMBOLIZATION COIL BROKE DURING USE. THE COIL BROKE DURING THE PLACEMENT OF THE ANGIOGRAM CATHETER. THE BROKEN COIL WAS REMOVED USING A "TRAP". ADDITIONALLY, A PHOTO OF THE COIL WAS PROVIDED WHICH SHOWS ELONGATION AND SEPARATION OF THE COIL. THE PROCEDURE WAS COMPLETED BY USING ANOTHER NEW DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19269530 ↗MalfunctionApr 30, 2024Material Separation; Material Separation
IT WAS REPORTED THAT A 'MREYE EMBOLIZATION COIL' SEPARATED DURING AN EMBOLIZATION PROCEDURE IN THE FUNDUS OF STOMACH. OTHER COILS WERE DEPLOYED IMMEDIATELY TO COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19217217 ↗MalfunctionApr 30, 2024Material Separation; Material Separation
IT WAS REPORTED THAT A 'MREYE EMBOLIZATION COIL' SEPARATED DURING AN EMBOLIZATION PROCEDURE IN THE FUNDUS OF THE STOMACH. OTHER COILS WERE DEPLOYED IMMEDIATELY TO COMPLETE THE PROCEDURE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19217084 ↗InjuryMar 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: High Blood Pressure/ Hypertension; Hypersensitivity/Allergic reaction; Rash; Swelling/ Edema
MAUDE report 18987794 ↗MalfunctionNov 3, 2023Entrapment of Device; Improper or Incorrect Procedure or Method; Difficult to Advance; Entrapment of Device; Improper or Incorrect Procedure or Method; Difficult to Advance
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18067906 ↗MalfunctionOct 19, 2023Entrapment of Device; Improper or Incorrect Procedure or Method; Difficult to Advance; Entrapment of Device; Improper or Incorrect Procedure or Method; Difficult to Advance
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17970024 ↗InjuryFeb 17, 2023Difficult to Advance; Migration; Difficult to Advance; Migration
IT WAS REPORTED THAT A MREYE EMBOLIZATION COIL MIGRATED. THE DEVICE WAS REQUIRED FOR EMBOLIZATION OF A SEQUESTER ARTERY. DURING THE PROCEDURE, THE USER PLACED TWO UNKNOWN COILS. WHEN ATTEMPTING TO PLACE A THIRD, MREYE COIL, THE COIL WOULD NOT ADVANCE OUT OF THE CATHETER. UPON ATTEMPTED REMOVAL, THE MREYE COIL EMBOLIZED THE RIGHT ILIAC ARTERY. AS A RESULT, THE PATIENT EXPERIENCED "BORDERLINE COMPARTMENT SYNDROME" AND A "POSSIBLE TROPHIC PROBLEM". THE FOLLOWING DAY, AN ARTERIOTOMY SURGERY WAS REQUIRED TO REMOVE THE COIL FROM THE RIGHT ILIAC ARTERY. THE PATIENT ALSO REQUIRED AN EXTENDED STAY IN THE "ITE". NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Embolism/Embolus; Reduced Blood Flow
MAUDE report 16399533 ↗MalfunctionJan 18, 2022Migration; Migration
IN ADDITIONAL INFORMATION RECEIVED ON 04MAR2022, IT WAS REPORTED THAT THE ANATOMICAL TARGET VESSEL WAS THE LEFT HYPOGASTRIC VEIN, 9MM. ONE YEAR LATER, THE PATIENT WAS HOSPITALIZED WITH CHEST PAIN AND INCIDENTAL COIL IN A PULMONARY ARTERY BRANCH. COIL MIGRATION WAS ORIGINALLY DISCOVERED ON 24DEC2021. EVALUATION BY INTERVENTIONAL RADIOLOGY FOR POSSIBLE RETRIEVAL WAS DONE AT THE FACILITY, BUT WAS DECLINED BY THE PATIENT. THE PATIENT BELIEVES THAT THEIR CHEST PAIN AND RECURRENT LEG SWELLING RESULTED FROM THIS EMBOLIZATION AND IS SEEKING A SECOND OPINION FOR RETRIEVAL. NO ANTICOAGULATION MEDICATIONS ARE BEING USED BY THE PATIENT.
Patient problems: Chest Pain; No Clinical Signs, Symptoms or Conditions; Swelling/ Edema
MAUDE report 13285434 ↗MalfunctionSep 15, 2020Material Separation; Material Separation
IT WAS REPORTED AN UNKNOWN PATIENT REQUIRED PLACEMENT OF AN MREYE EMBOLIZATION COIL FOR A COIL EMBOLIZATION OF A COLLATERAL VESSEL OF THE PULMONARY ARTERY. AFTER PLACING THE COIL, THE OPERATOR NOTICED THE COIL WAS SEPARATED. ONE FRAGMENT WAS PLACED IN THE COLLATERAL VESSEL AND THE OTHER REMAINED INSIDE THE CATHETER. THE FRAGMENT IN THE COLLATERAL VESSELS "SEEMED TO EMBOLIZE THE COLLATERAL VESSELS" SO IT WAS DETERMINED THE PROCEDURE WAS COMPLETED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10535431 ↗InjuryMay 6, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Foreign Body In Patient
MAUDE report 8583227 ↗MalfunctionJun 21, 2018Stretched
THE COMPLAINANT REPORTED THAT THE MREYE EMBOLIZATION COIL COULD NOT EXIT FROM THE END OF THE CATHETER. THE CATHETER AND THE COIL WERE REMOVED FROM THE PATIENT'S BODY, AND OTHER COIL SIZES WERE USED TO COMPLETE THE PROCEDURE. IT WAS FURTHER NOTED THAT THE COIL WAS STRETCHED APPROXIMATELY 6CM (CENTIMETERS), MEASURING 4MM (MILLIMETERS) FROM THE DISTAL OR NON-WELDED END OF THE COIL. THERE WERE NO REPORTED SERIOUS INJURIES TO THE PATIENT AS A RESULT OF THE PRODUCT PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7625242 ↗MalfunctionJun 21, 2018Stretched
THE COMPLAINANT REPORTED THAT THE MREYE EMBOLIZATION COIL COULD NOT EXIT FROM THE END OF THE CATHETER. THE CATHETER AND THE COIL WERE REMOVED FROM THE PATIENT'S BODY, AND OTHER COIL SIZES WERE USED TO COMPLETE THE PROCEDURE. IT WAS FURTHER NOTED THAT THE COIL WAS STRETCHED. THERE WERE NO REPORTED SERIOUS INJURIES TO THE PATIENT AS A RESULT OF THE PRODUCT PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7625144 ↗MalfunctionJun 21, 2018Entrapment of Device; Stretched; Failure to Advance
THE COMPLAINANT REPORTED THAT THE MREYE EMBOLIZATION COIL GOT STUCK IN ANOTHER MANUFACTURER'S CATHETER DURING ADVANCEMENT AND COULD NOT BE PUSHED INTO THE VESSEL. IT WAS FURTHER NOTED THAT THE COIL WAS "SEVERELY" STRETCHED WITH APPROXIMATELY 55CM (CENTIMETERS) OF THE STRETCHED COIL EXITING THE DISTAL END OF THE CATHETER. THERE WERE NO REPORTED SERIOUS INJURIES TO THE PATIENT AS A RESULT OF THE PRODUCT PROBLEM.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7624778 ↗MalfunctionJun 20, 2018Stretched; Structural Problem; Activation, Positioning or Separation Problem
IT WAS REPORTED THAT THE EMBOLIZATION COIL HAD DEPLOYMENT ISSUES AND IT CURLED NEAR THE HUB-LUMEN CONNECTION. FURTHERMORE, IT WAS NOTED THAT THE COIL WAS STRETCHED AT THE NON-WELDED END. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7622323 ↗InjuryMay 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED DURING A PDA CLOSURE, THE MREYE EMBOLIZATION COIL WAS DEPLOYED AND IT MIGRATED TO THE RIGHT PULMONARY ARTERY. THE COIL WAS RETRIEVED VIA SNARE BUT UPON REMOVAL IT MIGRATED AGAIN TO THE LEFT PULMONARY ARTERY. THE COIL WAS AGAIN SNARED AND RETRIEVED FROM THE PATIENT¿S BODY. AS REPORTED, THE DEVICE DID NOT MALFUNCTION AND THIS WAS A RARE PATIENT ANOMALY. THE PATIENT WAS DISCHARGED IN STABLE CONDITION AND DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.
Patient problems: No Code Available; No Known Impact Or Consequence To Patient
MAUDE report 7525359 ↗
Other Cook Incorporated products
All Cook Incorporated devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page