MicroNester G26989Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00827002269897), received between Aug 10, 2016 and Jan 2, 2025 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2025Entrapment of Device; Difficult to Advance; Entrapment of Device; Difficult to Advance

  NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21058787 ↗
• MalfunctionApr 13, 2022Stretched; Failure to Advance; Stretched; Failure to Advance

  IT WAS REPORTED A NESTER PLATINUM EMBOLIZATION MICROCOIL WAS DIFFICULT TO ADVANCE AND STRETCHED. THE COIL WAS BEING USED TO EMBOLIZE A SPLENIC ARTERY ANEURYSM IN A PATIENT WITH VERY TORTUOUS ANATOMY. THE COIL WAS LOADED WITHOUT DIFFICULTY AND ADVANCED THROUGH A 2.7 FR MICROCATHETER. DURING ADVANCEMENT, RESISTANCE WAS NOTED. THE COIL WOULD NOT ADVANCE PASSED A "TIGHT FLEXION POINT" IN THE PATIENT'S ANATOMY AND AT THE HOOK OF A COAXIAL CATHETER. WHEN THE WIRE WAS REMOVED, THE COIL CAME BACK TO THE HUB WITH THE WIRE. THE PHYSICIAN THEN TRIED TO ADVANCE THE COIL AGAIN WITH A DIFFERENT WIRE. THE COIL WAS NOTED TO LOOK STRETCHED UNDER FLUOROSCOPY. THE COIL WAS EVENTUALLY ABLE TO BE DEPLOYED USING A SALINE FLUSH AND THE CASE WAS COMPLETED WITH NO ISSUES. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14106398 ↗
• MalfunctionDec 10, 2019Unraveled Material; Unraveled Material

  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 9446525 ↗
• InjuryMay 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED ON (B)(6) 2017 A PATIENT THAT UNDERWENT GONADAL VEIN EMBOLISATION (LEFT SIDE VARICOCELE) WAS SUFFERING FROM LOCALIZED PAIN AT THE SURGICAL SITE. ON (B)(6) 2018, THE PATIENT REPORTED HE STILL HAD COMPLICATION/PAIN IN THE SURGICAL AREA. AT THIS TIME, THE PATIENT¿S MEDICAL TEAM DETERMINED HE DEVELOPED AN ALLERGIC REACTION TO THE IMPLANTED COILS/FIBERS. THE TEAM STATED THEY ARE PLANNING TO REMOVE THE COILS AND/OR HIS GONADAL VEIN WITH ASSOCIATED OR AFFECTED ORGANS. ON (B)(6) 2018, SPECIFIC DEVICES, LOTS AND QUANTITIES OF THE IMPLANTED COILS WERE REPORTED. AS REPORTED, A TOTAL OF 33 VARIOUS COOK INC. COILS AND AN UNSPECIFIED AMOUNT OF COMPETITOR COILS WERE IMPLANTED TWO MONTHS BEFORE (B)(6) 2017. THE FOLLOWING MEDWATCH REPORTS ARE FOR COILS IMPLANTED IN THIS SAID PATIENT. MEDWATCH 1820334-2018-01398 ¿ LOT 7423636 ¿ QUANTITY 5 DEVICES; MEDWATCH 1820334-2018-01399 ¿ LOT 7292138 ¿ QUANTITY 4 DEVICES; MEDWATCH 1820334-2018-01400 ¿ LOT 7815839 ¿ QUANTITY 3 DEVICES; MEDWATCH 1820334-2018-03888 ¿ LOT 7858778 ¿ QUANTITY 6 DEVICES; MEDWATCH 1820334-2018-01389 ¿ LOT 7698119 ¿ QUANTITY 7 DEVICES; MEDWATCH 1820334-2018-01390 ¿ LOT 7262416 ¿ QUANTITY 8 DEVICES.

  Patient problems: Foreign Body Reaction

  MAUDE report 7506634 ↗
• MalfunctionSep 8, 2017Material Deformation; Material Deformation

  AN INTERNATIONAL CUSTOMER REPORTED THAT COIL EMBOLIZATION WAS PERFORMED TO TREAT A TYPE II ENDOLEAK. THE CUSTOMER ATTEMPTED TO ADVANCE A NESTER PLATINUM EMBOLIZATION MICROCOIL INTO THE CATHETER, HOWEVER IT GOT STUCK AT THE HUB OF THE CATHETER. DEFORMATION OF THE COIL WAS OBSERVED AND ALSO THERE WAS A HAIR-SHAPED METAL PIECE ASSOCIATED THEREWITH. ANOTHER COIL WAS USED INSTEAD TO COMPLETE THE PROCEDURE. THERE HAS BEEN NO ADVERSE EFFECT TO THE PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6851902 ↗
• 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 6500643 ↗
• InjuryAug 10, 2016Break; Break

  A GOOSENECK SNARE WAS BEING USED TO RETRIEVE A MALPOSITIONED COIL DURING AN ARTERIOVENOUS (AV) FISTULA PROCEDURE AND THE COIL REPORTEDLY CAME APART INTO TWO PIECES. THE INNER PART OF THE COIL REMAINED STRAIGHT AND THE OUTER PART OF THE COIL CORRECTLY COILED. BOTH PIECES OF THE COIL WERE ABLE TO BE RETRIEVED USING THE GOOSENECK SNARE. A SECOND COIL WAS PLACED AND AGAIN, A GOOSENECK SNARE WAS BEING USED TO RETRIEVE THE COIL AS IT WAS MALPOSITIONED. THE EXACT SAME EVENT OCCURRED WITH THE SECOND SNARE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 5865855 ↗