MicroNester G26988Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00827002269880), received between Apr 18, 2017 and Jan 9, 2025 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2025Material Separation; Unraveled Material; Material Separation; Unraveled Material

  IT WAS REPORTED A NESTER PLATINUM EMBOLIZATION MICROCOIL SEPARATED AND DEPLOYED TO AN INCORRECT LOCATION DURING AN EMBOLIZATION PROCEDURE ON AN UNKNOWN PATIENT. THE ENTIRE COIL BECAME STUCK AND SPLIT INTO TWO PARTS WITHIN THE MICROCATHETER. ONE LINEAR PORTION OF THE COIL DEPLOYED IN THE TARGET VESSEL, AND THE SECOND PORTION DEPLOYED WITHIN THE AORTA DUE TO THE LOSS OF COIL PUSHABILITY. THE DEPLOYED TWO PART COIL WAS REMOVED FROM THE PATIENT WITH A SNARE. THE PROCEDURE WAS COMPLETED USING THE SAME MICROCATHETER AND THREE SIMILAR COOK NESTER MICROCOILS. 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 21112749 ↗
• MalfunctionOct 24, 2024Separation Failure; Difficult to Advance; Separation Failure; Difficult to Advance

  IT WAS REPORTED THAT A NESTER PLATINUM EMBOLIZATION MICROCOIL WAS DIFFICULT TO DEPLOY DURING AN EMBOLIZATION OF AN ABDOMINAL ARTERY IN A PATIENT OF UNKNOWN AGE AND GENDER. THE DOCTOR USED A PUSHER STYLET TO ADVANCE THE COIL INTO A MICROCATHETER. SUBSEQUENTLY, A 0.016-INCH GUIDEWIRE WAS USED TO FURTHER PUSH THE COIL TO THE TARGET LESION. RESISTANCE WAS ENCOUNTERED WHILE ADVANCING; HOWEVER, THE COIL AND WIRE WERE STILL ABLE TO ADVANCE. FOLLOWING ATTEMPTED DEPLOYMENT OF THE COIL FROM MICROCATHETER TIP, THE WIRE WAS WITHDRAWN. IT WAS FOUND THAT THE COIL AND WIRE WERE STUCK TOGETHER, RESULTING IN REMOVAL OF THE ENTIRE DEVICE INCLUDING MICROCATHETER, GUIDEWIRE AND THE COIL FROM THE PATIENT. ALTERNATIVE COOK COILS WERE USED TO COMPLETE THE PROCEDURE, AND THEY WERE FUNCTIONING WELL. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. IT WAS CONFIRMED BY THE USER THAT THE CATHETER WAS FLUSHED PRIOR TO EACH COIL DEPLOYMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20523970 ↗
• MalfunctionSep 24, 2020Entrapment of Device; Material Separation; Stretched; Difficult to Advance; Entrapment of Device; Material Separation; Stretched; 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 Known Impact Or Consequence To Patient

  MAUDE report 10583440 ↗
• MalfunctionJun 21, 2018Sticking; Stretched

  THE COMPLAINANT REPORTED THAT THE NESTER PLATINUM EMBOLIZATION MICROCOIL WAS STUCK INSIDE OF THE MICROCATHETER. IT WAS FURTHER NOTED THAT THE DISTAL 15CM (CENTIMETERS) OF THE CATHETER WAS STRETCHED. A NEW MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE, AND 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 7625014 ↗
• InjuryApr 18, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER STATED THAT A PATIENT UNDERWENT A SPLENIC EMBOLIZATION PROCEDURE ON AN UNSPECIFIED DATE TO CONTROL BLEEDING FOLLOWING AN ACCIDENT. THE PATIENT DEVELOPED A SKIN RASH / ALLERGIC REACTION AND LOW GRADE FEVER A FEW WEEKS FOLLOWING THE PROCEDURE. THE PATIENT WAS PRESCRIBED EUCERIN AND HYDROCORTISONE CREAM FOR CONTACT DERMATITIS. THE HOSPITAL LINENS WERE CHANGED TO HYPOALLERGENIC. THE RASH AND FEVER CONTINUED FOR THREE MORE DAYS SPREADING TO THE PATIENT'S CHEST, SHOULDERS AND ARMS. THE PATIENT RETURNED TO THE EMERGENCY ROOM AND WAS TREATED WITH INTRAVENOUS PREDNISONE AND BENADRYL AND WAS ALSO GIVEN A PRESCRIPTION FOR THE SAME FOR SEVERAL MORE DAYS. THE RASH CLEARED UP. THE PATIENT THEN DEVELOPED HIVES IN RANDOM SPOTS AND A PIMPLE-LIKE BUMPY RASH AND ITCHING ON THE HANDS, WRIST, HIPS, GROIN, ANKLE, CALVES AND FEET. THE PATIENT WAS SEEN BY AN ALLERGIST ON (B)(6) 2017 AND PRESCRIBED LEVOCETIRIZINE TABLETS AND PERMETHRIN CREAM; THERE WAS NO RELIEF FROM EITHER MEDICATION. ON (B)(6) 2017 THE PATIENT'S PRIMARY CARE PHYSICIAN PRESCRIBED METHYLPREDNISOLONE TABLETS WHICH WAS TAKEN FOR FOUR DAYS. THE PATIENT HAS SHOWN IMPROVEMENT, HOWEVER, WAITING TO SEE HOW THE PATIENT WILL REACT WHEN

  Patient problems: Foreign Body Reaction

  MAUDE report 6500623 ↗
• InjuryApr 18, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REPORTER STATED THAT A PATIENT UNDERWENT A SPLENIC EMBOLIZATION PROCEDURE ON AN UNSPECIFIED DATE TO CONTROL BLEEDING FOLLOWING AN ACCIDENT. THE PATIENT DEVELOPED A SKIN RASH / ALLERGIC REACTION AND LOW GRADE FEVER A FEW WEEKS FOLLOWING THE PROCEDURE. THE PATIENT WAS PRESCRIBED EUCERIN AND HYDROCORTISONE CREAM FOR CONTACT DERMATITIS. THE HOSPITAL LINENS WERE CHANGED TO HYPOALLERGENIC. THE RASH AND FEVER CONTINUED FOR THREE MORE DAYS SPREADING TO THE PATIENT'S CHEST, SHOULDERS AND ARMS. THE PATIENT RETURNED TO THE EMERGENCY ROOM AND WAS TREATED WITH INTRAVENOUS PREDNISONE AND BENADRYL AND WAS ALSO GIVEN A PRESCRIPTION FOR THE SAME FOR SEVERAL MORE DAYS. THE RASH CLEARED UP. THE PATIENT THEN DEVELOPED HIVES IN RANDOM SPOTS AND A PIMPLE-LIKE BUMPY RASH AND ITCHING ON THE HANDS, WRIST, HIPS, GROIN, ANKLE, CALVES AND FEET. THE PATIENT WAS SEEN BY AN ALLERGIST ON (B)(6) 2017 AND PRESCRIBED LEVOCETIRIZINE TABLETS AND PERMETHRIN CREAM; THERE WAS NO RELIEF FROM EITHER MEDICATION. ON (B)(6) 2017 THE PATIENT'S PRIMARY CARE PHYSICIAN PRESCRIBED METHYLPREDNISOLONE TABLETS WHICH WAS TAKEN FOR FOUR DAYS. THE PATIENT HAS SHOWN IMPROVEMENT, HOWEVER, WAITING TO SEE HOW THE PATIENT WILL REACT WHEN

  Patient problems: Foreign Body Reaction

  MAUDE report 6500614 ↗