Retracta G34197Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10827002341972), received between May 13, 2018 and Apr 30, 2026 — classified as 2 injuries, 10 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2026Difficult or Delayed Separation

  THE FOLLOWING EVENT REGARDING RETRACTA DETACHABLE EMBOLIZATION COILS WAS REPORTED VIE THE LITERATURE ARTICLE: NASSAR, M.; HOLT, M.; AFIFI, A.M.; NAZZAL, M. AN UNCOMMON COMPLICATION OF COIL EMBOLIZATION: COIL DEPLOYMENT SYSTEM MALFUNCTION LEADING TO RETAINED INTRA-AORTIC WIRE. J. VASC. SURG. CASES INNOV. TECH. 2026, 12, HTTPS://DOI.ORG/10.1016/J.JVSCIT.2026.102155. CASE REPORT "A 52-YEAR-OLD WOMAN WITH A PAST MEDICAL HISTORY OF NOONAN SYNDROME AND HYPERLIPIDEMIA WHO WAS ADMITTED OWING TO LETHARGY AND ACUTE KIDNEY INJURY. NOONAN SYNDROME IS A GENETIC DISORDER THAT IS ASSOCIATED WITH SHORT STATURE, CHARACTERISTIC FACIES, AND HEART DEFECTS; SOME PATIENTS HAVE COAGULATION DEFECTS. THE PATIENT SUBSEQUENTLY DEVELOPED SHORTNESS OF BREATH AND MELENA, WHICH WAS ATTRIBUTED TO UPPER GI BLEEDING. IN ADDITION, SHE WAS FOUND TO HAVE SUBMASSIVE PULMONARY EMBOLISM WITH RIGHT HEART STRAIN. IT IS UNCLEAR WHETHER THERE WAS A CONTRIBUTION OF THE PATIENT¿S HISTORY OF NOONAN SYN-DROME TO HER COAGULOPATHY, BUT IT DOES RAISE SUSPICION. THE PATIENT WAS TAKEN TO THE ENDOVASCULAR SUITE FOR ENDOSCOPIC EVALUATION AND INTERVENTION FOR THE GI BLEED AND CATHETER-DIRECTED MECHANICAL THROMBECTOMY OF THE PULMONARY AR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25046317 ↗
• MalfunctionJan 2, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT A RETRACTA DETACHABLE EMBOLIZATION COIL HAD "COME OFF" THE CATHETER. THE PHYSICIAN USED ANOTHER DEVICE TO COMPETE THE PROCEDURE. 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 21057825 ↗
• MalfunctionOct 10, 2024Entrapment of Device; Difficult or Delayed Separation; Entrapment of Device; 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20423066 ↗
• MalfunctionJun 6, 2024Premature Separation; Premature Separation

  IT WAS REPORTED THAT A RETRACTA DETACHABLE EMBOLIZATION COIL DEPLOYED PREMATURELY DURING PREPARATION. THE COMPLAINT DEVICE WAS DISPOSED BY THE USER FACILITY. 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 19477168 ↗
• MalfunctionOct 20, 2023Premature Separation; Premature Separation

  IN ADDITIONAL INFORMATION, IT WAS REPORTED THE CATHETER WAS FLUSHED PRIOR TO EACH COIL DEPLOYMENT. THE PHYSICIAN IS UNSURE WHAT CAUSED THE CATHETER TO PREMATURELY DEPLOY. HE NOTED WHEN HE USES THE REPORTED CATHETER WITH THE RETRACTA COIL, THE COIL DOES NOT DEPLOY CORRECTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17977155 ↗
• MalfunctionDec 1, 2022Unraveled Material; Separation Failure; Unraveled Material; Separation Failure

  IN ADDITIONAL INFORMATION RECEIVED ON (B)(6). 2022, IT WAS REPORTED THAT THE PROBLEM OCCURRED WHEN ATTEMPTING TO RELEASE THE COIL FROM THE DELIVERY WIRE. A REPLACEMENT DEVICE WAS NOT USED DURING THE PROCEDURE. THE COIL WAS TO BE RELEASED BETWEEN THE INFERIOR VENA CAVA AND THE MESENTERIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15896997 ↗
• InjuryApr 12, 2022Material Separation; Material Separation

  IT WAS REPORTED THE DELIVERY WIRE OF A RETRACTA DETACHABLE EMBOLIZATION COIL SEPARATED. THE DEVICE WAS REQUIRED FOR USE DURING A FISTULA GRAM WAS TO BE PLACED IN THE BRACHIAL VEIN. DURING THE PROCEDURE, WHEN THE USER ATTEMPTED TO DETACH THE COIL, THE DELIVERY WIRE BROKE. THE USER ATTEMPTED TO GRASP THE WIRE FRAGMENT BUT WAS UNSUCCESSFUL. AS A RESULT, THE PATIENT REQUIRED A CUT-DOWN PROCEDURE TO SUCCESSFULLY REMOVED THE WIRE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT. IT SHOULD BE NOTED THIS WAS THE ONLY COIL PLACED. THE PHYSICIAN DID NOT FLUSH THE CATHETER BEFORE COIL DEPLOYMENT. THE TORQUE DEVICE WAS USED DURING DEPLOYMENT. THE COIL JUNCTION WAS WITHIN THE TIP OF THE CATHETER DURING DEPLOYMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 14088163 ↗
• MalfunctionJul 13, 2020Stretched; Unraveled Material; Difficult or Delayed Separation; Stretched; Unraveled Material; 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: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10268005 ↗
• InjuryJul 22, 2019Material Separation; Separation Failure; Material Separation; Separation Failure

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

  Patient problems: No Code Available

  MAUDE report 8813160 ↗
• MalfunctionJun 21, 2018Difficult to Remove; Retraction Problem; Stretched

  IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO DETACH THE RETRACTA EMBOLIZATION COIL WHEN AN ATTEMPT WAS MADE TO DEPLOY IT, AND IT WAS THEN REMOVED SUCCESSFULLY. IT WAS FURTHER NOTED THAT A SECTION OF THE COIL WAS ELONGATED. THERE WAS NO REPORTED IMPACT TO THE PATIENT AS A RESULT OF THE PRODUCT ISSUE. ADDITIONAL INFORMATION WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7626888 ↗
• MalfunctionJun 21, 2018Entrapment of Device; Stretched; Failure to Advance

  THE COMPLAINANT REPORTED THAT THE RETRACTA EMBOLIZATION COIL WAS STUCK AT THE JUNCTION OF THE TIP OF THE CATHETER AND WOULD NOT ADVANCE THROUGH IT. FURTHERMORE, IT WAS NOTED THAT THE COIL WAS STRETCHED ON THE END OF THE END 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 7626463 ↗
• MalfunctionMay 13, 2018Break; Break

  IT WAS REPORTED DURING A COIL IMPLANTATION, THE DELIVERY WIRE ON A RETRACTA DETACHABLE EMBOLIZATION COIL BROKE. THIS BREAKAGE OCCURRED WHEN THE DOCTOR ATTEMPTED TO DEPLOY THE COIL BY TURNING THE GUIDE CARRIER, HOWEVER, THE COIL WAS WOUND WITH PART OF THE GUIDE. AS RESISTANCE WAS FELT, THE DOCTOR FORCEFULLY PULLED ON THE DEVICE, WHICH MADE THE COIL DEPLOY AND WIRE BREAK. 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 7509704 ↗