NesterRecalls & reported problems across all models
Cook Incorporated · 38 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Nester model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 71
- Deaths reported
- 0
- Injuries reported
- 35
- Recalls
- 1
We found 38 models of Nester by Cook Incorporated in the FDA's device registry (GUDID). Together they are named in 71 adverse event reports in the FDA's MAUDE database, received between Apr 6, 2016 and Apr 6, 2026 — classified as 35 injuries, 36 malfunctions.
The most frequently reported specific device problem is “Unraveled Material” (15 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
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
Nester recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- May 5, 2022Open, Classified
The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.
Z-1241-2022 · Root cause: Under Investigation by firm · names 12 of these models · Recall details · FDA record ↗
Most reported Nester problems
Device problems
- Unraveled Material15
- Difficult to Advance12
- Migration12
- Adverse Event Without Identified Device or Use Problem8
- Entrapment of Device8
- Failure to Advance7
- Migration or Expulsion of Device7
- Inadequacy of Device Shape and/or Size5
Patient problems
- No Clinical Signs, Symptoms or Conditions27
- No Code Available14
- Patient Problem/Medical Problem10
- No Known Impact Or Consequence To Patient8
- Pain7
- Insufficient Information6
- Nerve Damage4
- Autoimmune Disorder3
Nester models
38 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Nester G47333Device, Vascular, for Promoting Embolization1 recall1 report
- Nester G47331Device, Vascular, for Promoting Embolization1 recall0 reports
- Nester G47332Device, Vascular, for Promoting Embolization1 recall0 reports
- Nester G47334Device, Vascular, for Promoting Embolization1 recall0 reports
- Nester G47335Device, Vascular, for Promoting Embolization1 recall0 reports
- Nester G47337Device, Vascular, for Promoting Embolization1 recall0 reports
- Nester G47338Device, Vascular, for Promoting Embolization1 recall0 reports
- Nester G47339Device, Vascular, for Promoting Embolization1 recall0 reports
- Nester G47340Device, Vascular, for Promoting Embolization1 recall0 reports
- Nester G47341Device, Vascular, for Promoting Embolization1 recall0 reports
- Nester G47342Device, Vascular, for Promoting Embolization1 recall0 reports
- Nester G47344Device, Vascular, for Promoting Embolization1 recall0 reports
- Nester G26992Device, Vascular, for Promoting Embolization15 reports
- Nester G26995Device, Vascular, for Promoting Embolization11 reports
- Nester G26991Device, Vascular, for Promoting Embolization4 reports
- Nester G52751Device, Vascular, for Promoting Embolization4 reports
- Nester G26993Device, Vascular, for Promoting Embolization3 reports
- Nester G26994Device, Vascular, for Promoting Embolization3 reports
- Nester G47352Device, Vascular, for Promoting Embolization3 reports
- Nester G52752Device, Vascular, for Promoting Embolization3 reports
- Nester G52756Device, Vascular, for Promoting Embolization3 reports
- Nester G47327Device, Vascular, for Promoting Embolization2 reports
- Nester G47329Device, Vascular, for Promoting Embolization2 reports
- Nester G47345Device, Vascular, for Promoting Embolization2 reports
- Nester G47355Device, Vascular, for Promoting Embolization2 reports
- Nester G23523Device, Vascular, for Promoting Embolization1 report
- Nester G23525Device, Vascular, for Promoting Embolization1 report
- Nester G23532Device, Vascular, for Promoting Embolization1 report
- Nester G47325Device, Vascular, for Promoting Embolization1 report
- Nester G47346Device, Vascular, for Promoting Embolization1 report
- Nester G47357Device, Vascular, for Promoting Embolization1 report
- Nester G47365Device, Vascular, for Promoting Embolization1 report
- Nester G47372Device, Vascular, for Promoting Embolization1 report
- Nester G47375Device, Vascular, for Promoting Embolization1 report
- Nester G52742Device, Vascular, for Promoting Embolization1 report
- Nester G52743Device, Vascular, for Promoting Embolization1 report
- Nester G52747Device, Vascular, for Promoting Embolization1 report
- Nester G52754Device, Vascular, for Promoting Embolization1 report
Recent Nester adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionApr 6, 2026Expulsion
IT WAS REPORTED THAT A NESTER PLATINUM EMBOLIZATION COIL ERODED THROUGH A VESSEL WALL. THE COIL WAS PLACED ON AN UNKNOWN DATE DURING A BRTO [BALLOON-OCCLUDED RETROGRADE TRANSVENOUS OBLITERATION] PROCEDURE FOR THE TREATMENT OF GASTRIC VARICES. THE TARGET SITE WAS A GASTRIC VARIX WHICH, "BASED ON THE COIL SIZE, WAS ESTIMATED TO BE =18 MM. HOWEVER, IT WAS SOFT AND HAD AN IRREGULAR, NODULAR APPEARANCE, SUGGESTIVE OF A CONGLOMERATION OF VARICES." ACCORDING TO THE USER, NO RESISTANCE OR OTHER ISSUES WERE NOTED UPON DEPLOYMENT OF THE COIL. SEVERAL MONTHS AFTER THE COIL PLACEMENT, ENDOSCOPY REVEALED THAT THE COIL HAD PROTRUDED INTO THE STOMACH. THE PATIENT IS CURRENTLY UNDER OBSERVATION. THE TREATMENT TEAM IS CONSIDERING WHETHER THE COIL SHOULD BE CUT AND IS CONSIDERING POSSIBLE COMPLICATIONS THAT COULD OCCUR RELATED TO ITS EXPOSURE IN THE STOMACH. NO PATIENT SYMPTOMS ARE PRESENT AT THIS TIME. ON (B)(6) 2026, THE COOK SALES REPRESENTATIVE VISITED THE PHYSICIAN AND REVIEWED PHOTOGRAPHS, WHICH SHOWED APPROXIMATELY 5 TO 7 CM OF COIL PROTRUDING FROM TWO LOCATIONS. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. AN ADDITIONAL COIL
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24793073 ↗MalfunctionApr 6, 2026Expulsion
IT WAS REPORTED THAT A NESTER PLATINUM EMBOLIZATION COIL ERODED THROUGH A VESSEL WALL. THE COIL WAS PLACED ON AN UNKNOWN DATE DURING A BRTO [BALLOON-OCCLUDED RETROGRADE TRANSVENOUS OBLITERATION] PROCEDURE FOR THE TREATMENT OF GASTRIC VARICES. THE TARGET SITE WAS A GASTRIC VARIX WHICH, "BASED ON THE COIL SIZE, WAS ESTIMATED TO BE =18 MM. HOWEVER, IT WAS SOFT AND HAD AN IRREGULAR, NODULAR APPEARANCE, SUGGESTIVE OF A CONGLOMERATION OF VARICES." ACCORDING TO THE USER, NO RESISTANCE OR OTHER ISSUES WERE NOTED UPON DEPLOYMENT OF THE COIL. SEVERAL MONTHS AFTER THE COIL PLACEMENT, ENDOSCOPY REVEALED THAT THE COIL HAD PROTRUDED INTO THE STOMACH. THE PATIENT IS CURRENTLY UNDER OBSERVATION. THE TREATMENT TEAM IS CONSIDERING WHETHER THE COIL SHOULD BE CUT AND IS CONSIDERING POSSIBLE COMPLICATIONS THAT COULD OCCUR RELATED TO ITS EXPOSURE IN THE STOMACH. NO PATIENT SYMPTOMS ARE PRESENT AT THIS TIME. ON 31MAR2026, THE COOK SALES REPRESENTATIVE VISITED THE PHYSICIAN AND REVIEWED PHOTOGRAPHS, WHICH SHOWED APPROXIMATELY 5 TO 7CM OF COIL PROTRUDING FROM TWO LOCATIONS. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. AN ADDITIONAL COIL FOR
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24793056 ↗MalfunctionFeb 24, 2026Unraveled Material
IT WAS REPORTED THAT THE NESTER PLATINUM EMBOLIZATION COIL UNRAVELED. UPON RELEASE OF THE NESTER COIL DURING AN UNKNOWN EMBOLIZATION PROCEDURE FOR AN UNKNOWN PATIENT, THE COIL "DID NOT UNWIND COMPLETELY AND BECAME FRAYED (APPARENTLY SPLIT LENGTHWISE). IN ADDITION, SEVERAL KNOTS FORMED, PARTICULARLY IN THE PROBE, WHERE THEY REMAINED STUCK. THE FURTHER THE PROBE WAS WITHDRAWN, THE MORE THE COIL STRETCHED." THE DEVICE WAS EXCHANGED FOR AN UNKNOWN NEW DEVICE. THE DEVICE WAS NOT RETAINED IN THE PATIENT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24427826 ↗MalfunctionOct 7, 2024Unraveled Material; Unraveled Material
ADDITIONAL INFORMATION WAS PROVIDED ON 10OCT2024. THE DAMAGE TO THE COIL WAS DISCOVERED DURING THE PLACEMENT PROCEDURE. THE DAMAGE TO THE COIL WAS DESCRIBED AS "ACCIDENTLY DELIVER IN THE CATHETER - (ELONGATED)." THE COIL WAS REMOVED FROM THE PATIENT BY REMOVING THE CATHETER AND COIL OFF OF THE WIRE GUIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20384488 ↗MalfunctionApr 24, 2024Unraveled Material; Unraveled Material
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19174421 ↗MalfunctionJan 17, 2024Entrapment of Device; Unraveled Material; Difficult to Advance; Entrapment of Device; Unraveled Material; Difficult to Advance
IT WAS REPORTED THAT A NESTER PLATINUM EMBOLIZATION MICROCOIL ELONGATED. DURING ADVANCEMENT OF THE COIL INTO THE VESSEL, THE COIL BECAME LODGED IN THE CATHETER. THE CATHETER AND COIL WERE REMOVED FROM THE PATIENT, AND PULLING OF THE COIL WAS NOTED. THE REMOVED COIL APPEARED EXTENDED AND UNCOILED. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18527959 ↗MalfunctionJan 12, 2024
DEVICE WAS DAMAGED AND NOT PLACED IN PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18502132 ↗MalfunctionDec 4, 2023Unraveled Material; Malposition of Device; Unraveled Material; Malposition of Device
IT WAS REPORTED THAT A NESTER PLATINUM EMBOLIZATION COIL UNRAVELED. DURING THE PROCEDURE, THE COIL WAS "MAL-DEPLOYED" AND PROTRUDED INTO THE RENAL VEIN. WHEN THE COIL WAS RETRIEVED, IT UNRAVELED AND ELONGATED. A PROVIDED PHOTO SHOWS THE REPORTED FAILURE. 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 18260908 ↗MalfunctionAug 30, 2023Difficult to Advance; Difficult to Advance
IN ADDITIONAL INFORMATION RECEIVED ON 31AUG2023, IT WAS CONFIRMED THAT THE CATHETER WAS FLUSHED WITH SALINE PRIOR TO COIL INSERTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17652940 ↗MalfunctionApr 18, 2023Inadequacy of Device Shape and/or Size; Migration; Inadequacy of Device Shape and/or Size; Migration
IT WAS REPORTED THERE WAS INCIDENT INVOLVING A NESTER PLATINUM EMBOLIZATION COIL. AFTER THE NESTER COIL WAS DEPLOYED IN AN UNKNOWN PATIENT, THE NESTER COIL WOULD NOT COIL, BUT REMAINED MORE STRAIGHT. AS A RESULT, THE PHYSICIAN DEPLOYED A STENT TO KEEP THE COIL IN PLACE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16765553 ↗MalfunctionMar 30, 2023Material Separation; Material Separation
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 16644135 ↗MalfunctionJan 16, 2023Entrapment 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 Clinical Signs, Symptoms or Conditions
MAUDE report 16174278 ↗InjuryNov 2, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT A NESTER PLATINUM EMBOLIZATION MICROCOIL DID NOT FORM PROPERLY IN THE 8MM VESSEL OF AN UNKNOWN MALE PATIENT DURING EMBOLIZATION PROCEDURE FOR A SPLENIC BLEED. AS THE PHYSICIAN PLACED THE COIL INTO THE PATIENT, IT DID NOT FORM INTO A COIL. ANOTHER COIL WAS USED BUT EXHIBITED THE SAME FAILURE. THE DEVICE WAS THEN REMOVED AND REPLACED WITH A THIRD LIKE DEVICE TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE CUSTOMER NOTED THAT THE COIL SIZES WERE 14X12 AND EITHER 14X4 OR 14X10 FOR THE OTHER. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS. THE DEVICE WAS REPORTED TO BE DISCARDED BY THE FACILITY. THIS REPORT CAPTURES ONE INSTANCE OF THE 14X4 OR 14X10 COIL NOT FORMING CORRECTLY. THE SECOND OCCURRENCE IS REFERENCED IN A REPORT WITH PATIENT IDENTIFIER: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15715755 ↗InjuryNov 2, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size
IT WAS REPORTED THAT A NESTER PLATINUM EMBOLIZATION MICROCOIL DID NOT FORM PROPERLY IN THE 8MM VESSEL OF AN UNKNOWN MALE PATIENT DURING EMBOLIZATION PROCEDURE FOR A SPLENIC BLEED. AS THE PHYSICIAN PLACED THE COIL INTO THE PATIENT, IT DID NOT FORM INTO A COIL. ANOTHER COIL WAS USED BUT EXHIBITED THE SAME FAILURE. THE DEVICE WAS THEN REMOVED AND REPLACED WITH A THIRD LIKE DEVICE TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE CUSTOMER NOTED THAT THE COIL SIZES WERE 14X12 AND EITHER 14X4 OR 14X10 FOR THE OTHER. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS. THE DEVICE WAS REPORTED TO BE DISCARDED BY THE FACILITY. THIS REPORT CAPTURES ONE INSTANCE OF THE 14X12 COIL NOT FORMING CORRECTLY. THE SECOND OCCURRENCE IS REFERENCED IN A REPORT WITH PATIENT IDENTIFIER: (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15714861 ↗MalfunctionOct 19, 2022Entrapment of Device; Difficult to Advance; Entrapment of Device; 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 15633150 ↗
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.
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