Retracta G34190Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10827002341903), received between Jun 20, 2018 and Jan 2, 2024 — classified as 7 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2024Premature Separation; Premature Separation

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

  Patient problems: Insufficient Information

  MAUDE report 18430954 ↗
• MalfunctionApr 11, 2023Separation Failure; Separation Failure

  IT WAS REPORTED, THAT A RETRACTA DETACHABLE EMBOLIZATION COIL WAS UNABLE TO BE DEPLOYED DURING AN UNKNOWN PROCEDURE, IN AN UNKNOWN PATIENT. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED. BUT IT UNAVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16717977 ↗
• MalfunctionJan 18, 2022Migration; Migration

  IT WAS REPORTED AN UNKNOWN PATIENT HAD RETRACTA DETACHABLE EMBOLIZATION COILS AND MREYE EMBOLIZATION COILS PLACED. FOURTEEN MONTHS AFTER PLACEMENT, THE PATIENT UNDERWENT A SCAN AND IT WAS DISCOVERED THE COILS MIGRATED TO THE PULMONARY ARTERY. THE PATIENT IS ASYMPTOMATIC. ADDITIONAL INFORMATION INCLUDING EVENT DETAILS AND FURTHER PATIENT INFORMATION AND OUTCOME HAVE BEEN REQUESTED, BUT ARE CURRENTLY UNKNOWN. THE REPORTS WITH THE FOLLOWING PATIENT IDENTIFIERS CAPTURE THE COILS INVOLVED IN THIS INCIDENT: (B)(6) (THIS REPORT).

  Patient problems: Chest Pain; No Clinical Signs, Symptoms or Conditions; Swelling/ Edema

  MAUDE report 13285482 ↗
• MalfunctionJan 8, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED AN UNKNOWN PATIENT REQUIRED A RETRACTA DETACHABLE EMBOLIZATION COIL FOR A HEMOSTASIS OF A SPLENIC BLEED. AFTER ADVANCING THE COIL TO THE TARGET LOCATION, IT TOOK AN ESTIMATED 5-7 MINUTES OF TURNING THE TORQUE DEVICE IN ORDER TO RELEASE THE COIL FROM THE DELIVERY WIRE. ULTIMATELY, THE DEVICE WAS SUCCESSFULLY DEPLOYED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11140288 ↗
• MalfunctionJan 7, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED AN UNKNOWN PATIENT REQUIRED A RETRACTA DETACHABLE EMBOLIZATION COIL FOR A GONADAL EMBOLIZATION PROCEDURE. WHILE ATTEMPTING TO DEPLOY THE COIL IN THE TARGET LOCATION, THE COIL WOULD NOT DETACH FROM THE DELIVERY WIRE. THE USER REPORTEDLY HAD NO DIFFICULTY WITH ADVANCEMENT AND AFTER SEVERAL ATTEMPTS OF REPOSITIONING THE COIL, WAS ABLE TO DEPLOY IT IN THE DESIRED LOCATION. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11132643 ↗
• MalfunctionDec 31, 2020Difficult or Delayed 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: No Consequences Or Impact To Patient

  MAUDE report 11101601 ↗
• MalfunctionJun 20, 2018Failure to Advance

  THE COMPLAINANT REPORTED THAT THE EMBOLIZATION COIL WOULD NOT ADVANCE THROUGH THE CATHETER. IT WAS FURTHER NOTED THAT THE WHOLE COIL WAS STRETCHED. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THERE WAS NO REPORTED IMPACT TO THE PATIENT AS A RESULT OF THE PRODUCT ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7623252 ↗