Nester G26995Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00827002269958), received between Apr 6, 2017 and Jan 25, 2021 — classified as 6 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJan 25, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

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

  Patient problems: Nerve Damage; No Code Available; Pain

  MAUDE report 11223136 ↗
• MalfunctionNov 1, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED A NESTER PLATINUM EMBOLIZATION COIL WAS INSPECTED PRIOR TO USE. AN UNIDENTIFIED PARTICLE WAS OBSERVED INSIDE THE SEALED, PRIMARY PACKAGING. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

  Patient problems: No Patient Involvement

  MAUDE report 9266127 ↗
• InjuryApr 16, 2019Unraveled Material; Unraveled Material

  IT WAS REPORTED A NESTER PLATINUM EMBOLIZATION COIL USED IN A (B)(6) FEMALE FOR OVARIAN VEIN EMBOLIZATION. REPORT STATES AS THE LAST COIL WAS DEPLOYED, COIL WOULD ADVANCE FURTHER AND WAS NOTED TO HAVE UNRAVELED (ELONGATED) IN THE RENAL VEIN. THE COIL WAS RETRIEVED SUCCESSFULLY IN A SECOND PROCEDURE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

  Patient problems: No Code Available

  MAUDE report 8520184 ↗
• MalfunctionAug 9, 2018Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT DURING A FISTULOGRAM WITH COILING PROCEDURE, A NESTER PLATINUM EMBOLIZATION COIL UNRAVELED INSIDE THE CATHETER. THE PHYSICIAN ATTEMPTED TO FLUSH THE COIL OUT, BUT IT WOULD NOT LEAVE THE CATHETER. AT THAT POINT, THE PHYSICIAN PULLED THE DEVICE, INSTALLED A NEW SYSTEM AND COMPLETED THE PROCEDURE SUCCESSFULLY. 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 7766738 ↗
• MalfunctionJun 20, 2018Entrapment of Device; Structural Problem; Failure to Advance

  THE COMPLAINANT REPORTED THAT THE EMBOLIZATION COIL BECAME STUCK WHEN ADVANCING IT THROUGH THE CATHETER. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. FURTHERMORE, IT WAS NOTED THAT THE COIL WAS STRETCHED THROUGHOUT THE LENGTH OF THE COIL. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7622862 ↗
• MalfunctionDec 4, 2017Unraveled Material; Unraveled Material

  THE INTERNATIONAL CUSTOMER REPORTED THAT THE COIL BECAME ELONGATED DURING AN UNSPECIFIED PROCEDURE. A PRELIMINARY INVESTIGATION OF THE RETURNED DEVICE REVEALED THAT THE COIL HAD UNRAVELED. THE OPERATOR REPORTED THAT THE DEVICE WAS USED IN COMPLIANCE WITH THE INSTRUCTIONS FOR USE (IFU). THE COILS WERE REPORTED TO BE "LOOKING OUT FROM THE ANEURYSM" AND WERE RETRACTED WITH RETRIEVAL FORCEPS CAUSING THE COILS TO BECOME ELONGATED. THE PROCEDURE WAS RESTARTED. THE CUSTOMER CONFIRMED NO PATIENT ADVERSE EVENTS RESULTED FROM THE ISSUE. THE INVESTIGATION OF THE COMPLAINT PRODUCT IS STILL ONGOING. THIS EVENT IS RELATED TO MDR #1820334-2017-04201.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7081835 ↗
• InjuryJul 1, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  PER FDA MW5069779: "REMOVAL OF COOK MEDICAL NESTER COILS AFTER ADVERSE ALLERGIC REACTION AND MIGRATION TO THE RENAL VEIN. SURGICAL OPINION UPON REMOVAL WAS THAT THESE COILS WERE RELEASED TOO CLOSE TO THE RENAL VEIN. PT WAS IMPLANTED WITH COILS TO TREAT "PAIN" REPORTED TO HIS PHYSICIAN. THE PHYSICIAN ADVISED THAT HE BELIEVED THE PT. TO HAVE VARICOCELE AND REQUIRED EMBOLIZATION AS A TREATMENT. AFTER IMPLANTATION, THE PT EXPERIENCED ELEVATED EOSINOPHILS, INCREASED DISCOMFORT IN THE TREATED AREA. RAPID DECREASE OF TOTAL TESTOSTERONE (BELOW NORMAL RANGE OF 300), POOR LIVER FUNCTION. PT HAD NO PREVIOUS MEDICAL HISTORY OF THESE ISSUES PRIOR TO IMPLANTATION, ADDITIONALLY, THE PT WAS UNABLE TO PERFORM BASIC TASKS THAT HE PREVIOUSLY HAD NO ISSUES PERFORMING (SUCH AS DRIVING A MANUAL TRANSMISSION VEHICLE). THE PT HAD THE COILS REMOVED ON (B)(6) 2017 BY DR. WHO WAS ABLE TO SUCCESSFULLY REMOVE THE COILS." THIS IS ONE OF SIX MEDWATCH REPORTS BEING SUBMITTED AS THE CUSTOMER REPORTED TWO SEPARATE EVENTS INVOLVING THREE DIFFERENT PRODUCT LOT NUMBERS. REFERENCE MDR NUMBERS: 1820334-2017-01607, 1820334-2017-01608, 1820334-2017-01609, 1820334-2017-01610, 1820334-2017-01611, 1820334-2017-01612 THE SAME

  Patient problems: No Code Available

  MAUDE report 6683454 ↗
• InjuryJul 1, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  PER FDA MW5069779: ¿REMOVAL OF COOK MEDICAL NESTER COILS AFTER ADVERSE ALLERGIC REACTION AND MIGRATION TO THE RENAL VEIN. SURGICAL OPINION UPON REMOVAL WAS THAT THESE COILS WERE RELEASED TOO CLOSE TO THE RENAL VEIN. PT WAS IMPLANTED WITH COILS TO TREAT ¿PAIN¿ REPORTED TO HIS PHYSICIAN. THE PHYSICIAN ADVISED THAT HE BELIEVED THE PT. TO HAVE VARICOCELE AND REQUIRED EMBOLIZATION AS A TREATMENT. AFTER IMPLANTATION, THE PT EXPERIENCED ELEVATED EOSINOPHILS, INCREASED DISCOMFORT IN THE TREATED AREA. RAPID DECREASE OF TOTAL TESTOSTERONE (BELOW NORMAL RANGE OF 300), POOR LIVER FUNCTION. PT HAD NO PREVIOUS MEDICAL HISTORY OF THESE ISSUES PRIOR TO IMPLANTATION, ADDITIONALLY, THE PT WAS UNABLE TO PERFORM BASIC TASKS THAT HE PREVIOUSLY HAD NO ISSUES PERFORMING (SUCH AS DRIVING A MANUAL TRANSMISSION VEHICLE). THE PT HAD THE COILS REMOVED ON (B)(6) 2017 BY DR. WHO WAS ABLE TO SUCCESSFULLY REMOVE THE COILS.¿ THIS IS ONE OF SIX MEDWATCH REPORTS BEING SUBMITTED AS THE CUSTOMER REPORTED TWO SEPARATE EVENTS INVOLVING THREE DIFFERENT PRODUCT LOT NUMBERS. REFERENCE MDR NUMBERS: 1820334-2017-01607, 1820334-2017-01608, 1820334-2017-01609, 1820334-2017-01610, 1820334-2017-01611, 1820334-2017-01612 THE SAME

  Patient problems: No Code Available

  MAUDE report 6683452 ↗
• InjuryJul 1, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER FDA MW5069779: "REMOVAL OF COOK MEDICAL NESTER COILS AFTER ADVERSE ALLERGIC REACTION AND MIGRATION TO THE RENAL VEIN. SURGICAL OPINION UPON REMOVAL WAS THAT THESE COILS WERE RELEASED TOO CLOSE TO THE RENAL VEIN. PT WAS IMPLANTED WITH COILS TO TREAT "PAIN" REPORTED TO HIS PHYSICIAN. THE PHYSICIAN ADVISED THAT HE BELIEVED THE PT. TO HAVE VARICOCELE AND REQUIRED EMBOLIZATION AS A TREATMENT. AFTER IMPLANTATION, THE PT EXPERIENCED ELEVATED EOSINOPHILS, INCREASED DISCOMFORT IN THE TREATED AREA. RAPID DECREASE OF TOTAL TESTOSTERONE (BELOW NORMAL RANGE OF 300), POOR LIVER FUNCTION. PT HAD NO PREVIOUS MEDICAL HISTORY OF THESE ISSUES PRIOR TO IMPLANTATION, ADDITIONALLY, THE PT WAS UNABLE TO PERFORM BASIC TASKS THAT HE PREVIOUSLY HAD NO ISSUES PERFORMING (SUCH AS DRIVING A MANUAL TRANSMISSION VEHICLE). THE PT HAD THE COILS REMOVED ON (B)(6) 2017 BY DR. WHO WAS ABLE TO SUCCESSFULLY REMOVE THE COILS." THIS IS ONE OF SIX MEDWATCH REPORTS BEING SUBMITTED AS THE CUSTOMER REPORTED TWO SEPARATE EVENTS INVOLVING THREE DIFFERENT PRODUCT LOT NUMBERS. REFERENCE MDR NUMBERS: 1820334-2017-01607, 1820334-2017-01608, 1820334-2017-01609, 1820334-2017-01610, 1820334-2017-01611, 1820334-2017-01612. THE SAM

  Patient problems: No Code Available; Reaction

  MAUDE report 6683449 ↗
• InjuryJul 1, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PER FDA MW5069779: ¿REMOVAL OF COOK MEDICAL NESTER COILS AFTER ADVERSE ALLERGIC REACTION AND MIGRATION TO THE RENAL VEIN. SURGICAL OPINION UPON REMOVAL WAS THAT THESE COILS WERE RELEASED TOO CLOSE TO THE RENAL VEIN. PT WAS IMPLANTED WITH COILS TO TREAT ¿PAIN¿ REPORTED TO HIS PHYSICIAN. THE PHYSICIAN ADVISED THAT HE BELIEVED THE PT. TO HAVE VARICOCELE AND REQUIRED EMBOLIZATION AS A TREATMENT. AFTER IMPLANTATION, THE PT EXPERIENCED ELEVATED EOSINOPHILS, INCREASED DISCOMFORT IN THE TREATED AREA. RAPID DECREASE OF TOTAL TESTOSTERONE (BELOW NORMAL RANGE OF 300), POOR LIVER FUNCTION. PT HAD NO PREVIOUS MEDICAL HISTORY OF THESE ISSUES PRIOR TO IMPLANTATION, ADDITIONALLY, THE PT WAS UNABLE TO PERFORM BASIC TASKS THAT HE PREVIOUSLY HAD NO ISSUES PERFORMING (SUCH AS DRIVING A MANUAL TRANSMISSION VEHICLE). THE PT HAD THE COILS REMOVED ON (B)(6) 2017 BY DR. WHO WAS ABLE TO SUCCESSFULLY REMOVE THE COILS.¿ THIS IS ONE OF SIX MEDWATCH REPORTS BEING SUBMITTED AS THE CUSTOMER REPORTED TWO SEPARATE EVENTS INVOLVING THREE DIFFERENT PRODUCT LOT NUMBERS. REFERENCE MDR NUMBERS: 1820334-2017-01607, 1820334-2017-01608, 1820334-2017-01609, 1820334-2017-01610, 1820334-2017-01611, 1820334-2017-01612 THE SAME

  Patient problems: No Code Available; Reaction

  MAUDE report 6683448 ↗
• MalfunctionApr 6, 2017Material Frayed; Material Frayed

  CUSTOMER REPORTED THAT A PATIENT WAS UNDERGOING AN ABDOMINAL AORTIC ANEURYSM REPAIR OF THE LEFT HYPOGASTRIC USING NESTER PLATINUM EMBOLIZATION COILS. THE COIL SHREDDED BUT WAS PROTECTED IN THE SHEATH. NOTHING REMAINED INSIDE OF THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6463769 ↗