Retracta G34188Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10827002341880), received between Jul 20, 2017 and Jul 13, 2022 — classified as 7 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (4 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.

• MalfunctionJul 13, 2022Failure to Advance; Difficult or Delayed Separation; Failure to Advance; Difficult or Delayed Separation

  IT WAS REPORTED THAT A RETRACTA DETACHABLE EMBOLIZATION COIL WAS DIFFICULT TO DEPLOY. THE DEVICE WAS REQUIRED FOR EMBOLIZATION OF A SPLENIC VESSEL. ACCESS WAS GAINED, THEN THE USER ADVANCED THE COIL THROUGH A 5FR CATHETER. HOWEVER, ONLY 2 LOOPS OF THE COIL WERE ABLE TO BE ADVANCED INTO THE PATIENTS ANATOMY. ADDITIONAL INFORMATION REGARDING THE EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE. 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 15001036 ↗
• MalfunctionMar 1, 2022Separation Failure; Separation Failure

  IT WAS REPORTED, DURING A FISTULA COILING PROCEDURE, A RETRACTA DETACHABLE EMBOLIZATION COIL WOULD NOT DETACH FROM THE WIRE. THE TARGET VESSEL WAS IN THE ARM. THE TORQUE DEVICE WAS USED AND THE COIL JUNCTION WAS WITHIN THE TIP OF THE CATHETER DURING DEPLOYMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT COIL. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED, BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13638520 ↗
• InjuryMar 12, 2021Premature Separation; Premature Separation

  IN ADDITIONAL INFORMATION RECEIVED ON 18MAR2021, IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH COOK 0.035 PUSHABLE COILS AND 0.018 DETACHABLE COILS FROM ANOTHER MANUFACTURER. THE PATIENT DID NOT REQUIRE PROLONGED HOSPITALIZATION DUE TO THIS OCCURRENCE. NO ADDITIONAL PATIENT INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11477216 ↗
• MalfunctionJan 29, 2021Unraveled Material; Difficult or Delayed Separation; Premature Separation; Unraveled Material; Difficult or Delayed Separation; Premature Separation

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11250428 ↗
• MalfunctionSep 2, 2020Material Separation; Separation Failure; Material Separation; Separation Failure

  ADDITIONAL INFORMATION PROVIDED 22SEP2020 STATED THE VESSEL WAS A RIGHT LOWER LOBE SUBSEGMENTAL PULMONARY ARTERY BRANCH. THE OPERATOR STATED THE SHEATH AND CATHETER WERE GUIDED APPROPRIATELY ON THE PATH FROM THE INFERIOR VENA CAVA, THROUGH THE RIGHT PULMONARY VEIN, AND INTO THE TARGET SITE. THE COIL WAS CORRECTLY POSITIONED IN THE TARGET SITE WHEN IT WAS ATTEMPTED TO BE DEPLOYED. ADDITIONALLY, EXAMINATION OF THE RETURNED DEVICE ON 22SEP2020 SHOWED ELONGATION OF THE DELIVERY WIRE, BUT NO EVIDENCE OF SEPARATION OF THE WIRE.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 10484877 ↗
• InjurySep 24, 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 Information

  MAUDE report 9109487 ↗
• InjurySep 16, 2019Retraction Problem; Separation Failure; Retraction Problem; Separation Failure

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

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9071862 ↗
• InjuryJan 23, 2019Material Fragmentation; Material Fragmentation

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

  Patient problems: Device Embedded In Tissue or Plaque; Foreign Body In Patient

  MAUDE report 8271176 ↗
• MalfunctionSep 17, 2018Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT RETRACTA DETACHABLE EMBOLIZATION COILS WERE USED DURING A BILIARY COILING PROCEDURE. IT WAS NOTED THAT TWO COILS DETACHED AS THEY WERE PUSHED THROUGH THE CATHETER. ONE COIL BUNCHED UP AT THE HUB OF THE CATHETER, WHILE THE OTHER WAS ASPIRATED BACK OUT OF THE CATHETER. THE COILS WERE THEN REMOVED FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH TWO COILS OF A DIFFERENT TYPE. THIS REPORT REFERENCES ONE DETACHED COIL, WHILE MEDWATCH 1820334-2018-02717 REFERENCES THE OTHER DETACHED COIL USED DURING THE PROCEDURE. 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 7882488 ↗
• InjuryDec 13, 2017Fracture; Fracture

  THE INTERNATIONAL CUSTOMER REPORTED THAT THE RETRACTA DETACHABLE EMBOLIZATION COIL RELEASE SYSTEM COULD NOT BE RETRACTED INTO THE CATHETER FOLLOWING THE DEPLOYMENT OF THE COILS. THE RELEASE SYSTEM (ALSO REFERRED TO AS "THE PUSHER" BY THE CUSTOMER) WAS STRETCHED OUT AND SUBSEQUENTLY BROKEN AS A RESULT OF THE ISSUE, AND A FRAGMENT WAS LEFT INSIDE THE PATIENT. THE PATIENT WAS LATER TAKEN TO THE OPERATING ROOM FOR THE REMOVAL OF THE FRAGMENT FROM THE RENAL ARTERY, WHICH THE CUSTOMER REPORTED "CONTINUED TO THE SKIN" (SIC). THE PRODUCT IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION.

  Patient problems: No Code Available

  MAUDE report 7114792 ↗
• InjuryNov 1, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  THE INTERNATIONAL CUSTOMER REPORTED THAT, DURING A CATHETERIZATION OF THE PEDIATRIC PATIENT'S LEFT SPERMATIC VEIN VIA AN ARM APPROACH, THE RETRACTA DETACHABLE EMBOLIZATION COIL WOULD NOT DETACH AS EXPECTED. THIS OCCURRED DESPITE THE FACT THAT THE DEVICE WAS ROTATED COUNTERCLOCKWISE BY THE OPERATOR AS USUAL FOLLOWING THE INTRODUCTION OF THE COIL. THE SITUATION ULTIMATELY NECESSITATED ADDITIONAL OPEN SURGERY TO REMOVE THE DISLODGED COILS AND REMOVE THE DEVICE FROM THE PATIENT'S ARM. THE COILS WERE RECOVERED, AND THE PATIENT IS REPORTEDLY DOING WELL. THE DEVICE IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED.

  Patient problems: No Code Available

  MAUDE report 6992725 ↗
• InjuryJul 20, 2017Difficult or Delayed Positioning; Difficult or Delayed Positioning

  CUSTOMER REPORTED THAT A PATIENT WAS UNDERGOING AN EMBOLIZATION PROCEDURE AT AN UNSPECIFIED ANATOMICAL SITE. THE RETRACTA DETACHABLE EMBOLIZATION COIL WOULD NOT RELEASE DURING PLACEMENT. THE COIL EVENTUALLY "UNFURLED." THE PHYSICIAN PLACED ANOTHER ACCESS DEVICE AND ADVANCED A SNARE INTO THE VESSEL TO REMOVE THE UNFURLED COIL. THE COIL WAS REMOVED AND DESCRIBED AS "ABOUT TWO FEET OF SMALL GAUGE WIRE." THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING OTHER COILS. THE PATIENT IS REPORTED AS "FINE." THERE WERE NO FURTHER ISSUES REPORTED. NO FURTHER INFORMATION HAS BEEN RECEIVED AS OF THE DATE OF THIS REPORT. THE DEVICE WAS RECEIVED BY THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Code Available

  MAUDE report 6727691 ↗