Retracta G34192Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002341927), received between Jan 5, 2021 and Jan 18, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Separation” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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).

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

  MAUDE report 13285142 ↗
• MalfunctionJan 5, 2021Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED AN UNKNOWN PATIENT REQUIRED SEVERAL RETRACTA DETACHABLE EMBOLIZATION COILS FOR A PERCUTANEOUS PORTAL VEIN EMBOLIZATION PROCEDURE. THE JUNCTION ZONE OF THE DELIVERY WIRE WAS CORRECTLY POSITIONED AND THE TORQUE DEPLOYMENT DEVICE WAS UTILIZED FOR EACH COIL. ALL OF THE COILS EVENTUALLY DEPLOYED, BUT SOME REQUIRED PROLONGED ROTATION OF THE DELIVERY WIRE. THE FOLLOWING PROVIDES INFORMATION REGARDING ALL THE COILS UTILIZED DURING THE PROCEDURE AND THEIR CORRESPONDING REPORTS. IT IS UNCLEAR WHICH AND HOW MANY COILS EXPERIENCED THE DIFFICULTY DEPLOYING. REPORTED UNDER PATIENT IDENTIFIER (B)(6) ¿ MWCER-35-7-14, LOT# 8263748, QUANTITY: 1; REPORTED UNDER PATIENT IDENTIFIER (B)(6) ¿ MWCER-35-7-16, LOT# 8045851, QUANTITY: 2; REPORTED UNDER PATIENT IDENTIFIER (B)(6) ¿ MWCER-35-7-8, LOT# 8302034, QUANTITY: 1; REPORTED UNDER PATIENT IDENTIFIER (B)(6) ¿ MWCER-35-7-8, LOT# 7264121, QUANTITY: 1; REPORTED UNDER PATIENT IDENTIFIER (B)(6) ¿ MWCER-35-14-14, LOT# 7829902, QUANTITY 1. 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 11118403 ↗