Retracta G34204Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10827002342047), received between Feb 29, 2016 and Aug 18, 2023 — classified as 3 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Separation” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 18, 2023Separation Failure; Difficult or Delayed Separation; Separation Failure; Difficult or Delayed Separation

  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 17573209 ↗
• InjuryMay 11, 2023Material Separation; Difficult or Delayed Separation; Material Separation; Difficult or Delayed Separation

  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 16914528 ↗
• InjuryMay 11, 2023Material Separation; Difficult or Delayed Separation; Material Separation; Difficult or Delayed Separation

  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 16912841 ↗
• MalfunctionJan 2, 2020Separation Failure; Separation Failure

  IT WAS REPORTED A MALE PATIENT REQUIRED PLACEMENT OF A RETRACTA DETACHABLE EMBOLIZATION COIL DURING A PERCUTANEOUS EMBOLIZATION PROCEDURE FOR A PSEUDOANEURYSM OF A HEPATIC ARTERY. AFTER THE COIL WAS ADVANCED IN A 5.0 FR KMP BEACON TIP CATHETER, "THE COILS WOULD NOT DETACHED FORM THE WIRE." THE OPERATOR SUCCESSFULLY COMPLETED THE PROCEDURE USING A COMBINATION OF NESTER COILS AND COILS OF ANOTHER MANUFACTURER. 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 9537773 ↗
• MalfunctionJan 2, 2020Separation Failure; Separation Failure

  IT WAS REPORTED A MALE PATIENT REQUIRED PLACEMENT OF A RETRACTA DETACHABLE EMBOLIZATION COIL DURING A PERCUTANEOUS EMBOLIZATION PROCEDURE FOR A PSEUDOANEURYSM OF A HEPATIC ARTERY. AFTER THE COIL WAS ADVANCED IN A 5.0 FR KMP BEACON TIP CATHETER, "THE COILS WOULD NOT DETACHED FORM THE WIRE." THIS FAILURE OCCURRED WITH TWO DEVICES OF THIS LOT. THE OPERATOR SUCCESSFULLY COMPLETED THE PROCEDURE USING A COMBINATION OF NESTER COILS AND COILS OF ANOTHER MANUFACTURER. 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 9537753 ↗
• MalfunctionJun 20, 2018Break; Positioning Failure; Mechanics Altered

  THE COMPLAINANT REPORTED THAT PRIOR TO PATIENT CONTACT, THE EMBOLIZATION COIL WAS STRAIGHT AND COULD NOT BE CONFIGURED OR DEPLOYED. IT WAS FURTHER NOTED THAT THE PROXIMAL END OF THE HUB WAS BROKEN OFF. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION WAS NOT PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7623176 ↗
• MalfunctionMay 5, 2017Break; Break

  CUSTOMER REPORTED THAT A PATIENT WAS UNDERGOING AN EMBOLIZATION OF THE INTERNAL ILIAC (HYPOGASTRIC) ARTERY WITH A RETRACTA DETACHABLE EMBOLIZATION COIL PRIOR TO REPAIR OF AN ABDOMINAL AORTIC ANEURYSM (AAA). THE PHYSICIAN REPORTED THAT THE COIL BROKE "A FEW CENTIMETERS" PROXIMAL TO THE ATTACHMENT ZONE. THE DISTAL END OF THE BROKEN WIRE WITH ATTACHED COIL REMAINED AS DEPLOYED IN-SITU WITHIN THE HYPOGASTRIC ARTERY. THE PHYSICIAN DEPLOYED THE RETRACTA DETACHABLE EMBOLIZATION COIL THROUGH A 6FR BALKIN SHEATH WITHOUT THE USE OF A CATHETER. THE PHYSICIAN WAS SUCCESSFUL IN OCCLUDING / EMBOLIZING THE ENTIRE HYPOGASTRIC ARTERY AND PROCEEDED TO COVER IT WITH THE INTENDED GORE ENDOVASCULAR AAA LIMB. THE PROCEDURE WAS COMPLETED UNEVENTFULLY. THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6547515 ↗
• InjuryFeb 29, 2016Material Separation

  INITIAL INFORMATION PROVIDED BY THE REPORTER STATES: DURING THE PROCEDURE, TWO RETRACTA DETACHABLE EMBOLIZATION COILS HAD BEEN PLACED AND AN ATTEMPT WAS MADE TO PLACE A THIRD RETRACTA DETACHABLE EMBOLIZATION COIL. DURING DEPLOYMENT IT WAS NOTED THAT THE THIRD COIL WOULD NOT SEPARATE. IT APPEARED THAT THE WIRE WAS SPUN CLOCKWISE AND COUNTER CLOCKWISE. A SLITHER OF THE RETRACTA WIRE WAS STILL ATTACHED TO THE COIL. NEW INFORMATION RECEIVED ON (B)(6) 2016 DETERMINED REPORTABILITY: UPON REVIEWING IMAGES PROVIDED BY THE REP, IT WAS CONFIRMED THAT THE DEVICE HAD SEPARATED AND A SEGMENT WAS LEFT IN THE PATIENT. A SMALL SLITHER OF WIRE REMAINED ATTACHED TO THE COIL. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 5466341 ↗