Retracta G34200Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10827002342009), received between Oct 31, 2014 and Jan 23, 2025 — classified as 6 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Unraveled Material” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2025Unraveled Material; Unraveled Material

  IN ADDITIONAL INFORMATION REPORTED ON 28JAN2025 AND 29JAN205, IT WAS REPORTED THAT THERE WAS NO DAMAGE NOTED TO THE DEVICE UPON OPENING THE PACKAGE. A COIL EMBOLIZATION DURING EVAR PROCEDURE WAS BEING COMPLETED AT THE TIME OF FAILURE AND TREATMENT SITE WAS WITHIN THE INTERNAL ILIAC. IMA EMBOLIZATION WAS ANOTHER EMBOLIC TREATMENT USED. IT WAS CONFIRMED THAT THE PHYSICIAN FLUSHED THE CATHETER PRIOR TO EACH COIL DEPLOYMENT. THE DEPLOYED COILS REMAINED IN THE TARGET VESSEL AND WERE NOT RETRIEVED. THEY WERE NOT STRETCHED OR COMPRESSED. THERE WAS NO DIFFICULTY ADVANCING THE PUSHER STYLET THROUGH THE SHIPPING CARTRIDGE. IT WAS CONFIRMED THAT THERE WAS DIFFICULTY DETACHING THE COIL FROM THE DELIVERY WIRE. THE COIL WAS REPOSITIONED ABOUT 2 TIMES. DIFFICULTY WAS EXPERIENCED WHEN RETRACTING THE WIRE/COIL, WITH THE COIL BEING UNABLE TO DETACH SUCCESSFULLY. AROUND 10 CLOCKWISE AND COUNTERCLOCKWISE TURNS WERE USED TO DETACH THE COIL. THE JUNCTION ZONE WAS JUST INSIDE THE TIP OF THE CATHETER DURING DEPLOYMENT AND WAS NOT DAMAGED THE PATIENT WAS NOT ON ANY ANTICOAGULATION MEDICATION. NO ALLERGIC REACTIONS OR ADVERSE EFFECTS WERE EXPERIENCED DUE TO THE OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21225761 ↗
• MalfunctionJan 20, 2025Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT THE DELIVERY WIRE INCLUDED IN RETRACTA DETACHABLE EMBOLIZATION COIL UNRAVELED DURING A COIL EMBOLIZATION PROCEDURE FOR ENDOVASCULAR ANEURYSM REPAIR (EVAR) IN A PATIENT OF UNKNOWN AGE AND GENDER. THE CUSTOMER NOTED THAT THERE WAS NO DAMAGE TO THE DEVICE UPON OPENING THE PACKAGE. A PUSHER STYLET WAS UTILIZED FOR COIL DEPLOYMENT AND WAS ADVANCED THROUGH THE SHIPPING CARTRIDGE WITHOUT DIFFICULTY. THE COIL WAS INTRODUCED VIA A TORTUOUS INTERNAL ILIAC ARTERY. IT WAS CONFIRMED THAT THERE WAS DIFFICULTY DETACHING THE COIL FROM THE DELIVERY WIRE, THE COIL WAS REPOSITIONED 2-3 TIMES. THERE WAS DIFFICULTY IN RETRACTING THE WIRE/COIL AS IT BECAME STUCK IN THE CATHETER. THE COIL DID NOT REMAIN IN THE TARGET VESSEL, AS IT WAS REMOVED ALONG WITH THE CATHETER AND WAS FOUND TO BE STRETCHED. THE COIL WAS ROTATED BOTH CLOCKWISE AND COUNTERCLOCKWISE, RESULTING IN ITS FAILURE TO DEPLOY. SUBSEQUENTLY, THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE PATIENT WAS UNDER ANTICOAGULANT THERAPY, AND NO ADDITIONAL EMBOLIC TREATMENT METHODS WERE USED DURING TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21193279 ↗
• InjuryNov 26, 2024Material Separation; Material Separation

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

  Patient problems: Foreign Body In Patient

  MAUDE report 20786227 ↗
• MalfunctionNov 20, 2024Break; Break

  IT WAS REPORTED THAT RETRACTA DETACHABLE EMBOLIZATION COIL SEPARATED DURING A COIL EMBOLIZATION PROCEDURE IN A PATIENT OF UNKNOWN AGE AND GENDER. THE CUSTOMER NOTED THAT THERE WAS NO DAMAGE TO THE DEVICE UPON OPENING THE PACKAGE. A DEDICATED PUSHER WAS UTILIZED FOR COIL DEPLOYMENT AND WAS ADVANCED THROUGH THE SHIPPING CARTRIDGE WITHOUT DIFFICULTY. THERE WERE NO ROTATIONS MADE DURING ADVANCEMENT INTO THE DELIVERY SITE. THE COIL WAS INTRODUCED VIA FEMORAL ARTERY (FA) AND GUIDED TO THE INTENDED LOCATION IN THE INTERNAL ILIAC ARTERY (IIA). IT WAS NOTED THAT HALF OF THE COIL REACHED THE TARGET AREA AND WAS FOUND TO BE STRETCHED. DURING THE IMPLANTATION PROCESS, THE COIL WAS ROTATED COUNTERCLOCKWISE BEYOND THE RECOMMENDED NUMBER OF ROTATIONS, RESULTING IN ITS FAILURE TO DEPLOY. UPON GENTLE TRACTION, THE COIL BROKE OFF INTO TWO PIECES, WITH ONE PORTION PARTIALLY RETRACTED INTO THE DELIVERY SYSTEM AND THE OTHER PORTION REMAINING IN THE INTENDED DEPLOYMENT LOCATION WITHIN THE PATIENT. THE CATHETER REMAINED INTACT, AND LABELING APPEARED UNAFFECTED. SUBSEQUENTLY, THE PROCEDURE WAS COMPLETED BY USING COMPETITOR¿S DEVICE. THE PATIENT WAS UNDER ANTICOAGULANT THERAPY, AND NO ADDITIONAL EMBOLIC TR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20736959 ↗
• MalfunctionJun 10, 2024Material Separation; Unraveled Material; Separation Failure; Material Separation; Unraveled Material; Separation Failure

  IT WAS REPORTED THAT DURING A PELVIC VEIN EMBOLIZATION PROCEDURE A RETRACTA DETACHABLE EMBOLIZATION COIL WOULD NOT FULLY DETACH. 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 19499967 ↗
• MalfunctionOct 5, 2023Premature Separation; Premature 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 17878022 ↗
• MalfunctionAug 28, 2023Separation Failure; Separation Failure

  IT WAS REPORTED THAT A RETRACTA DETACHABLE EMBOLIZATION COIL DID NOT RELEASE DURING ATTEMPTED DEPLOYMENT THROUGH A 5 FRENCH CATHETER DURING A VARICOCELE EMBOLIZATION OF THE LEFT GONADAL VEIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17638122 ↗
• MalfunctionMar 10, 2023Separation Failure; Separation Failure

  IT WAS REPORTED THAT A RETRACTA DETACHABLE EMBOLIZATION COIL COULD NOT BE DEPLOYED/DETACHED. ON (B)(6) 2023, DURING AN UNKNOWN PROCEDURE IN AN UNKNOWN PATIENT, THE RETRACTA COIL WAS FULLY PUSHED THROUGH THE CATHETER SYSTEM AND INTO THE TARGET VESSEL BUT COULD NOT BE DEPLOYED/DETACHED. AFTER SEVERAL ATTEMPTS, THE COIL WAS RETRACTED BACK AND TAKEN OUT OF THE PATIENT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED BUT IT CURRENTLY UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16522842 ↗
• InjuryNov 29, 2021Entrapment of Device; Failure to Advance; Separation Problem; Entrapment of Device; Failure to Advance; Separation Problem

  ON (B)(6) 2022 IT WAS CLARIFIED THAT THE PATIENT WAS TRANSFERRED TO THE NEAREST HOSPITAL FOR MEDICAL ASSESSMENT. THE ATRIAL TACHYCARDIA SELF RESOLVED AFTER ABOUT 6 HOURS.

  Patient problems: Hypoxia; Tachycardia

  MAUDE report 12887866 ↗
• MalfunctionJan 6, 2021Separation Failure; Separation Failure

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11124359 ↗
• 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 11102039 ↗
• MalfunctionMay 1, 2020Difficult to Remove; Difficult to Advance; Separation Problem; Difficult to Remove; Difficult to Advance; Separation Problem

  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 10018336 ↗
• MalfunctionJan 24, 2020Failure to Advance; Failure to Advance

  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 9629222 ↗
• InjuryDec 31, 2019Difficult to Remove; Material Separation; Separation Failure; Difficult to Remove; 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: Foreign Body In Patient

  MAUDE report 9536050 ↗
• InjuryFeb 13, 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

  MAUDE report 8334947 ↗
• MalfunctionJun 21, 2018Kinked; Difficult to Remove; Stretched

  THE COMPLAINANT REPORTED THAT THE EMBOLIZATION COIL WOULD NOT DETACH FROM THE DELIVERY WIRE AND WAS RETRACTED SUCCESSFULLY. IT WAS FURTHER NOTED THAT THE COIL WAS KINKED AND ELONGATED AND SUPPORTED AN ADVANCEMENT DIFFICULTY ERROR. 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 7626942 ↗
• MalfunctionJun 21, 2018Entrapment of Device; Stretched

  THE COMPLAINANT REPORTED THAT THE EMBOLIZATION MICRO COIL GOT STUCK WHEN ADVANCING THROUGH THE CATHETER. FURTHERMORE, IT WAS NOTED THAT THE COIL WAS STRETCHED THROUGHOUT THE ENTIRE LENGTH OF THE 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 7626655 ↗
• MalfunctionJun 21, 2018Kinked; Stretched; Failure to Advance

  IT WAS REPORTED THAT WHEN THE USER ATTEMPTED TO INSERT RETRACTA EMBOLIZATION COIL THROUGH THE CATHETER, A RESISTANCE WAS FELT AT THE CATHETER TIP AND IT HAD ADVANCEMENT DIFFICULTY. IN ADDITION, IT WAS REPORTED THAT ONE OF THE COILS WAS FRAYED. MOREOVER, IT WAS NOTED THAT THE COIL WAS STRETCHED, KINKED AND DAMAGED IN SEVERAL PLACES. OTHER COILS WERE USED IN ORDER TO FINISH THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7626526 ↗
• MalfunctionJun 21, 2018Entrapment of Device; Stretched

  THE COMPLAINANT REPORTED THAT ANOTHER MANUFACTURER'S CATHETER WAS POSITIONED IN THE SPLENIC ARTERY FOR EMBOLIZATION OF THE SPLENIC ARTERY AND X3 RETRACTA DETACHABLE EMBOLIZATION COIL HAD BEEN SUCCESSFULLY DEPLOYED. A 4TH RETRACTA DETACHABLE EMBOLIZATION COIL WAS ADVANCED THROUGH THE OTHER MANUFACTURER'S CATHETER AND BECAME JAMMED IN THE CATHETER. THE PHYSICIAN WAS UNABLE TO MOVE THE RETRACTA DETACHABLE EMBOLIZATION COIL WITHIN THE CATHETER, SO THE CATHETER HAD TO BE REMOVED WITH THE COIL STILL INSIDE. IT WAS FURTHER NOTED THAT THE COIL WAS STRETCHED APPROXIMATELY 10CM (CENTIMETERS) MEASURING APPROXIMATELY 5 MM (MILLIMETERS) FROM THE PROXIMAL END OF THE COIL. A NEW CATHETER WAS USED TO DEPLOY MORE RETRACTA AND NESTER COILS. THERE WERE NO REPORTED SERIOUS INJURIES TO THE PATIENT AS A RESULT OF THE PRODUCT PROBLEM.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7625072 ↗
• MalfunctionJun 20, 2018Device Damaged by Another Device

  IT WAS REPORTED THAT DURING THE VARICOCELE EMBOLIZATION PROCEDURE, THE PHYSICIAN WAS UNHAPPY WITH COIL POSITIONING THEREFORE THE DOCTOR ATTEMPTED TO RETRACT IT. HOWEVER, THE COIL SNAGGED ON THE PREVIOUSLY DEPLOYED COIL AND BOTH WERE EVENTUALLY REMOVED. WHEN THE DOCTOR ATTEMPTED TO FREE THE COIL BY PULLING BACK ON THE DELIVERY WIRE, THE COIL ELONGATED AND STRETCHED. ANOTHER COIL WAS SUCCESSFULLY PLACED AND THE PROCEDURE WAS COMPLETED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7621941 ↗
• InjuryApr 10, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED A RETRACTA DETACHABLE EMBOLIZATION COIL WAS UNABLE TO DETACH FROM THE DELIVERY WIRE DURING A PELVIC VEIN EMBOLISATION. THE DOCTOR APPLIED TENSION TO WITHDRAW THE DELIVERY WIRE BUT THE DEVICE SNAPPED. FLOUROSCOPY SHOWED THE DETACHED COIL WAS STUCK INSIDE THE CATHETER TIP. AN ADDITIONAL JUGULAR PUNCTURE WAS MADE TO INSERT A 6FR SNARE AS A SAFETY MEASURE SO THE INITIAL CATHETER, COIL, AND STRAIGHT PUSH WIRE WERE RETRACTED AS ONE UNIT OUT OF THE INTRODUCER.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 7412901 ↗
• MalfunctionMar 22, 2018Unraveled Material; Unraveled Material

  THE INTERNATIONAL CUSTOMER REPORTED THAT THE RETRACTA DETACHABLE EMBOLIZATION COIL WOULD NOT DEPLOY PROPERLY, AND BECAME UNRAVELED AND ELONGATED AS A RESULT. ACCESS TO THE LEFT COMMON ILIAC WAS INITIALLY OBTAINED VIA THE RIGHT COMMON FEMORAL, AND THE TARGET WAS THE PROXIMAL NECK OF THE LEFT ILIAC ANEURYSM. TWO RETRACTA COILS WERE THEN DEPLOYED WITH NO ISSUES. THE COMPLAINT PRODUCT WAS THEN ADVANCED THROUGH THE 5 FRENCH CATHETER AND THE 6 FRENCH SHEATH, AND THE COIL SEEMED TO DETACH "BEFORE ATTACHING THE TORQUE DEVICE" (SIC). UPON INSPECTION OF THE DEVICE FOLLOWING REMOVAL, THE WIRE WAS OBSERVED TO BE ELONGATED AND UNRAVELED. THE CUSTOMER CONFIRMED THAT NO ADDITIONAL PROCEDURES WERE REQUIRED TO CORRECT THE ISSUE, AND NO PATIENT ADVERSE EVENTS RESULTED. TO CORRECT THE CONDITION, THE OPERATOR DEPLOYED AND IMPLANTED ANOTHER COIL. THE COMPLAINT 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 Known Impact Or Consequence To Patient

  MAUDE report 7363121 ↗
• MalfunctionFeb 12, 2018Disconnection; Unraveled Material; Disconnection; Unraveled Material

  THE INTERNATIONAL CUSTOMER REPORTED THAT, WHEN THE RETRACTA DETACHABLE EMBOLIZATION COIL WAS ADVANCED THROUGH THE ANGIODYNAMICS SOS ANGIOGRAPHIC CATHETER, IT WAS DISCOVERED THAT THE COIL HAD DISCONNECTED. THE PROCEDURE PERTAINED TO THE COMMON ILIAC ANSATOMOSIS VESSEL LEAK CONNECTING TO TRANSPLANTED KIDNEY. THE CUSTOMER REPORTED THAT TORQUEING OF THE DELIVERY WIRE WAS RULED OUT AS A CAUSE OF THE ISSUE. THE CUSTOMER ADDITIONALLY CONFIRMED THAT THE PRODUCT PROBLEM DID NOT RESULT IN ANY ADVERSE PATIENT EFFECTS, AND DID NOT NECESSITATE ANY ADDITIONAL PROCEDURE. THE PRODUCT HAS BEEN RECEIVED FOR EVALUATION AND PER PHOTOGRAPHS ATTACHED, THE EMBOLIZATION COIL HAS ELONGATED. AS OF THE DATE OF THIS REPORT, THE INVESTIGATION IS STILL PENDING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7264741 ↗
• MalfunctionAug 28, 2017Unraveled Material; Unraveled Material

  THE INTERNATIONAL CUSTOMER REPORTED THAT THE DEVICE BECAME UNRAVELED DURING USE. THE UNRAVELING REPORTEDLY OCCURRED FOLLOWING THE DELIVERY OF THE COIL AS INTENDED BY THE OPERATOR. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6823465 ↗
• MalfunctionMar 29, 2017Detachment of Device or Device Component; Detachment of Device or Device Component

  INTERNATIONAL SALES REPRESENTATIVE REPORTED THAT THE DEVICE WAS BEING USED FOR DEMONSTRATION PURPOSES. THE REPRESENTATIVE LIFTED THE DEVICE OUT OF THE PACKAGE AND NOTED THE COIL WAS DETACHED. THE COIL REPORTEDLY WENT OUT OF THE NEEDLE ONCE THE PRIMARY PACKAGE WAS OPENED. THE REPRESENTATIVE STATED THAT THE WHITE SAFETY CLIP WAS NOT LOCKED. THE DEVICE WAS NOT USED CLINICALLY, ACCORDINGLY THERE WAS NO PATIENT CONTACT. THE DEVICE WAS RETURNED FOR EVALUATION.

  Patient problems: No Patient Involvement

  MAUDE report 6442368 ↗