Retracta G34198Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10827002341989), received between Sep 8, 2016 and Oct 22, 2024 — classified as 4 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 22, 2024Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT A RETRACTA DETACHABLE EMBOLIZATION COIL FAILED TO DETACH FROM THE DELIVERY WIRE DURING A COIL EMBOLIZATION PROCEDURE IN A PATIENT OF UNKNOWN AGE AND GENDER. THE INTERNAL ILIAC ARTERY WAS APPROACHED FROM THE FEMORAL ARTERY. AFTER THE DEVICE WAS DELIVERED TO THE PLACEMENT SITE, AN ATTEMPT WAS MADE TO DEPLOY THE COIL. THE COIL WAS REPOSITIONED SEVERAL TIMES AND WAS ROTATED COUNTERCLOCKWISE; HOWEVER, THE COIL COULD NOT BE DETACHED FROM THE DELIVERY WIRE. THE DEVICE WAS THEN REMOVED FROM THE PATIENT AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY USING ANOTHER LIKE-DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE CUSTOMER NOTED THAT THE DEVICE WAS UNDAMAGED UPON OPENING THE PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20509371 ↗
• MalfunctionDec 1, 2022Unraveled Material; Separation Failure; Unraveled Material; Separation Failure

  IN ADDITIONAL INFORMATION RECEIVED ON 14DEC2022, 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 15897306 ↗
• InjuryJul 12, 2022Material Separation; Stretched; Difficult or Delayed Separation; Material Separation; Stretched; Difficult or Delayed Separation

  IT WAS REPORTED THAT THE DELIVERY WIRE OF A RETRACTA DETACHABLE EMBOLIZATION COIL SEPARATED. THE DEVICE WAS REQUIRED FOR VARICOCELE EMBOLIZATION OF A 6 MM LEFT GONADAL VEIN. THE COIL FORMED PROPERLY IN THE VESSEL. HOWEVER, WHEN ATTEMPTING TO DETACH THE COIL UTILIZING THE TORQUE DEVICE, THE DELIVERY WIRE SPUN, BUT THE COIL WOULD NOT DETACH. THE USER THEN ATTEMPTED TO RETRACT THE COIL AND ENCOUNTERED TENSION. IT WAS DISCOVERED THAT THE DELIVERY WIRE WAS STRETCHED AND UNRAVELLING. "THE WIRE FINALLY BROKE OFF AFTER HE TRIED PULLING IT BECAUSE HE COULD NOT DO ANYTHING ELSE." ABOUT 120 CM OF THE DELIVERY WIRE WAS REMOVED; HOWEVER, A PORTION OF THE WIRE REMAINED ATTACHED THE COIL AND WAS RETAINED IN THE PATIENT. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 14988072 ↗
• InjuryFeb 10, 2022Material Separation; Difficult or Delayed Separation; Material Separation; Difficult or Delayed Separation

  IT WAS REPORTED AN UNKNOWN PATIENT REQUIRED A RETRACTA DETACHABLE EMBOLIZATION COIL FOR AN INTERNAL ILIAC EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE COIL WAS PARTIALLY DEPLOYED INTO THE RIGHT INTERNAL ILIAC BUT FAILED TO DETACH FROM THE DELIVERY WIRE. THE WIRE WAS RETRACTED AND ADVANCED AGAIN. THE COIL REPORTEDLY "PROLAPSED" INTO THE EXTERNAL ILIAC, SO THE COIL WAS REPOSITIONED IN THE CATHETER TIP. RESISTANCE WAS NOTED UPON ROTATING THE WIRE, AND THE WIRE WAS PULLED BACK. THE DELIVERY WIRE SEPARATED, LEAVING THE COIL, INCONEL JUNCTION, AND A 3CM PORTION OF WIRE IN THE PATIENT. THE WIRE FRAGMENT WAS STENTED IN PLACE AGAINST THE RIGHT ILIAC VESSEL AS PART OF A PLANNED ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE. THE WIRE FRAGMENT REMAINS IN THE PATIENT. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 13507873 ↗
• MalfunctionJan 4, 2022Stretched; Difficult or Delayed Separation; Stretched; Difficult or Delayed Separation

  IT WAS REPORTED A MALE PATIENT REQUIRED PLACEMENT OF A RETRACTA DETACHABLE EMBOLIZATION COIL FOR A LEFT VARICOCELE EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY DETACHING THE COIL FOR APPROXIMATELY TWO MINUTES. THE TORQUE DEVICE WAS USED AND THE WIRE WAS TURNED COUNTER CLOCKWISE. THE WIRE WAS PULLED BACK, AND THE COIL EVENTUALLY DETACHED. HOWEVER, THE COIL JUNCTION HAD UNRAVELED. IMAGING SHOWED THE COIL WAS STRETCHED INSIDE THE PATIENT'S VESSEL. THE PHYSICIAN WAS SATISFIED WITH THE COIL PLACEMENT, AND THE COIL REMAINS IN THE PATIENT. TWO SIMILAR COILS WERE PLACED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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 13158311 ↗
• MalfunctionDec 16, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION WAS PROVIDED ON 23FEB2022. THE DEVICE WAS BEING USED IN A SPLENIC EMBOLIZATION PROCEDURE BEING COMPLETED BY A RADIOLOGIST AT THE FACILITY. THE RADIOLOGIST USED A SELECTIVE CATHETER AND FLUSHED THE CATHETER BEFORE THE COIL ENTERED THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13019078 ↗
• InjuryOct 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CONTACT WAS MADE WITH THE SURGEON AND ADDITIONAL INFORMATION RELATED TO THE EVENT WAS REPORTED. THE SURGEON STATED: "I DON¿T THIS THE PATIENTS DISCOMFORT HAD ANYTHING TO DO WITH THE DEVICE. IT WAS SIMPLY A BIG VEIN WITH A LOT OF PELVIC VARICES. ITS APPROPRIATE PHLEBITIS CONSISTENT WITH THROMBOSIS OF THE VEIN. FURTHER THIS IS NOT A COMPLAINT IT IS AN OBSERVATION. SOMETHING THE CLINICIAN WILL HAVE TO BALANCE UP WHEN THEY OFFER RX FOR THIS ISSUE. DISCOMFORT OR TREATING THE VEIN VS THE BENEFIT OR OCCLUDING IT."

  Patient problems: Abdominal Pain

  MAUDE report 12632115 ↗
• MalfunctionApr 19, 2021Separation Problem; Difficult or Delayed Separation; Separation Problem; 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 11686453 ↗
• MalfunctionJan 7, 2021Separation Failure; Separation Failure

  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 11132479 ↗
• MalfunctionJan 6, 2021Separation Failure; Separation Failure

  IT WAS REPORTED A MALE PATIENT REQUIRED RETRACTA DETACHABLE EMBOLIZATION COILS FOR RIGHT INTERNAL ILIAC EMBOLIZATION FOR A FENESTRATED GRAFT IMPLANT PROCEDURE. DURING THE PROCEDURE, THREE OF THE COILS WOULD NOT RELEASE FROM THE DELIVERY WIRE. THE DEVICES WERE REMOVED AND REPLACED BY SIMILAR DEVICES TO COMPLETE THE PROCEDURE SUCCESSFULLY. 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 11125028 ↗
• MalfunctionJun 25, 2020Separation Failure; Separation Failure

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10194302 ↗
• InjuryJul 3, 2019Retraction Problem; Material Separation; Separation Failure; Retraction Problem; 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: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 8758383 ↗
• MalfunctionSep 17, 2018Fitting Problem; Fitting Problem

  IT WAS REPORTED 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 1820334-2018-02745 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 7882484 ↗
• MalfunctionJun 20, 2018Failure to Advance

  IT WAS REPORTED THAT DURING AN IIIAC EMBOLIZATION PROCEDURE, THE PHYSICIAN HAD DIFFICULTY IN ADVANCING THE COIL. THE COIL DID NOT REACH THE END OF THE CATHETER SO THE COIL WAS REMOVED, THE CATHETER WAS THEN CUT AND THE COIL RE-ADVANCED. THE DOCTOR HANDLED THE COIL DURING THIS WITH STICKY, BLOOD COVERED FINGERS AND THE COIL HAD STUCK TO THEM. WHEN THE COIL WAS FINALLY REMOVED IT HAD BEEN STRETCHED AND DAMAGED AND IT WAS NOTED THAT IT HAD SEPARATED INTO TWO PIECES. 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 7622292 ↗
• MalfunctionJun 20, 2018Kinked; Stretched; Physical Resistance

  IT WAS REPORTED THAT DURING THE VARICOCELE EMBOLIZATION PROCEDURE, THE PHYSICIAN FELT RESISTANCE AT THE DISTAL PART OF THE CATHETER. THE EMBOLIZATION COIL NEEDED EXTRA FORCE TO ADVANCE; THEREFORE, THE USER RETRACTED THE COIL AND NOTED A KINK AT THE CONNECTION TO THE DELIVERY WIRE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. FURTHERMORE, IT WAS NOTED THAT THE PROXIMAL END OF THE COIL WAS STRETCHED AND STUCK IN THE LOADING CARTRIDGE.

  Patient problems: No Information

  MAUDE report 7621963 ↗
• MalfunctionFeb 6, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  DURING A PELVIC CONGESTION EMBOLIZATION PROCEDURE, THE PHYSICIAN HAD INSERTED THE RETRACTA DETACHABLE EMBOLIZATION COIL, BUT ENCOUNTERED DIFFICULTY TO DEPLOY. IT WAS REPORTED THAT THE PHYSICIAN HAD TO ROTATE THE DEPLOYMENT WIRE ABOUT 30 TIMES TO GET THE COIL TO DEPLOY (1820334-2017-00213). A SECOND DEVICE OF A LARGER SIZE WAS REPORTED TO HAVE BEEN USED DURING THE SAME PROCEDURE. THE ATTENDING PHYSICIAN ALSO EXPERIENCED DIFFICULTY DEPLOYING THIS DEVICE. THE DEVICE WIRE BROKE WHILE THE ATTENDING WAS PERFORMING ADDITIONAL MANIPULATION TO DEPLOY THE COIL (1820334-2017-00040). THE PHYSICIAN OBTAINED A COMPETITORS' DEVICE AND SUCCESSFULLY COMPLETED THE PROCEDURE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6304147 ↗
• MalfunctionSep 8, 2016Difficult or Delayed Positioning; Difficult or Delayed Positioning

  DURING A VARICOCELE EMBOLIZATION TO SPERMADIC VEIN PROCEDURE, THE PHYSICIAN WAS TRYING TO DEPLOY THE RETRACTA COIL AND THE THREAD BECAME ENTANGLED WITH THE ADJACENT NESTER COIL THAT HAD ALREADY BEEN DEPLOYED. THIS PREVENTED A SMOOTH DEPLOYMENT, IT EVENTUALLY CAME OFF AFTER FORCEFUL MANIPULATION. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ADVERSE EFFECTS DUE TO THIS OCCURRENCE. NO PART OF THE DEVICE REMAINED INSIDE THE PATIENT. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5935406 ↗