Retracta G34201Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10827002342016), received between Dec 1, 2016 and Sep 26, 2024 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (8 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 26, 2024Unraveled Material; Difficult or Delayed Separation; Unraveled Material; Difficult or Delayed Separation

  IT WAS REPORTED THAT A RETRACTA DETACHABLE EMBOLIZATION COIL WAS DIFFICULT TO DETACH. THE DEVICE WAS REQUIRED FOR EMBOLIZATION OF A 13MM TORTUOUS RIGHT INTERNAL ILIAC ARTERY (IIA) ANEURYSM DURING AN ABDOMINAL AORTIC ANEURYSM (AAA) PROCEDURE. THE DEVICE WAS STORED VERTICALLY. NO DAMAGE TO THE PACKAGING WAS NOTED. DURING THE PROCEDURE, THE COIL WAS ADVANCED FROM THE LEFT FEMORAL ARTERY TO THE TARGET SITE. ONCE THE COIL WAS PLACED AT THE TARGET SITE, THE JUNCTION ZONE WAS POSITIONED JUST OUTSIDE THE CATHETER TIP, AND THE TORQUE DEVICE WAS USED TO TURN THE DELIVERY WIRE 30 TIMES; HOWEVER, THE COIL WOULD NOT DETACH. THE DELIVERY WIRE WAS RETRACTED, AND IT WAS PRESUMED THAT THE COIL HAD DETACHED AND WAS PLACED. THE PROCEDURE CONTINUED "AS USUAL" AND WAS SUCCESSFULLY COMPLETED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. IT WAS NOTED THE DELIVERY WIRE WILL BE RETURNED TO ENSURE THE COIL DETACHED CORRECTLY. A COMPETITOR¿S COILS WERE ALSO USED DURING THIS PROCEDURE. THE CATHETER WAS NOT FLUSHED BEFORE EACH COIL DEPLOYMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20309445 ↗
• MalfunctionSep 17, 2024Difficult 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 20242469 ↗
• MalfunctionJun 26, 2024Difficult or Delayed Separation; Difficult or Delayed Separation

  IN ADDITIONAL INFORMATION RECEIVED ON 27JUN2024, IT WAS REPORTED THAT THE USER ROTATED THE TORQUE DEVICE MORE THAN 15 ROTATIONS. THE TORQUE DEVICE WAS INITIALLY ROTATED COUNTERCLOCKWISE, AND THEN CLOCKWISE, WHEN THE USER SAW THAT IT DID NOT RELEASE. THE JUNCTION ZONE WAS NOT IN THE CORRECT POSITION INSIDE OF THE CATHETER TIP WHILE ATTEMPTING TO DEPLOY. THE USER WAS ADVISED TO ENSURE THAT THE JUNCTION WAS HALF IN AND HALF OUT OF THE CATHETER. THE USER THEN REPORTED THAT THE JUNCTION WAS IN THE CORRECT POSITION AND PROCEEDED TO ROTATE THE TORQUE DEVICE. FROM THE PERSPECTIVE OF THE REP, THE CATHETER WAS APPROXIMATELY 2CM ABOVE THE JUNCTION, AND THE USER WAS ADVISED AGAIN OF THE POSITION IMPORTANCE. THE USER THEN CONTINUED TO RAPIDLY ROTATE THE TORQUE DEVICE. HIGHLIGHTING THE CATHETER POSITION AND THE JUNCTION LOCATION ON THE SCREEN, THE USER THEN MOVED THE CATHETER DOWN TO THE JUNCTION. BEFORE THIS POINT THE COIL HAD BEEN ROTATED COUNTERCLOCKWISE NUMEROUS TIMES AND CLOCKWISE NUMEROUS TIMES BY THE USER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19615849 ↗
• MalfunctionSep 28, 2023Separation Failure; Separation Failure

  IT WAS REPORTED THE RETRACTA DETACHABLE EMBOLIZATION COIL WAS UNABLE TO BE DEPLOYED DURING A PELVIC VEIN EMBOLIZATION PROCEDURE IN THE LEFT OVARIAN VEIN. UPON OPENING THE PACKAGE, NO DAMAGE TO THE DEVICE WAS NOTED. THE DEVICE WAS USED TO EMBOLIZE THE NON-TORTUOUS TARGET VESSEL, LEFT OVARIAN 10 TO 12MM BY A VERY EXPERIENCED USER. THE TREATMENT SITE WITHIN THE VESSEL WAS DISTAL TO MID. COOK NESTER AND RETRACTA COILS AS WELL AS ANOTHER MANUFACTURER'S CATHETER WERE USED DURING THE PROCEDURE. THE PHYSICIAN FLUSHED THE CATHETER BEFORE EACH COIL DEPLOYMENT. THE COIL WAS REPOSITIONED MINIMALLY, ABOUT 1-2 TIMES. THERE WAS NO DIFFICULTY WITH RETRACTING THE WIRE/COIL. THE JUNCTION ZONE WAS NOT VISUALLY DAMAGED. 10+ COUNTERCLOCKWISE ROTATIONS WITH DEPLOYMENT MARKER IN CORRECT POSITION WITH REGARDS TO CATHETER TIP WERE USED TO ATTEMPT TO DETACH THE COIL. THE COIL WAS WITHDRAWN ATTACHED TO THE DELIVERY WIRE. THE COIL WAS NOT STRETCHED OR COMPRESSED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT'S OUTCOME WAS SATISFACTORY. THE PATIENT WAS NOT ON ANY ANTICOAGULATION MEDICATION. THE PATIENT DID NOT EXPERIENCE ANY ALLERGIC REACTION TO THE COIL. THIS FAILURE OCCURRED WITH THREE RETRACTA C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17835801 ↗
• MalfunctionApr 12, 2023Separation 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 16724245 ↗
• MalfunctionNov 21, 2022Migration; Migration

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15837610 ↗
• MalfunctionOct 11, 2022Material Separation; Material Separation

  IT WAS REPORTED A COOK RETRACTA DETACHABLE EMBOLIZATION COIL WAS DIFFICULT TO RETRACT. THE COIL BECAME ADHERED TO POSSIBLY A GRAFT STRUCTURE WHEN THE CATHETER WAS DEPLOYED AND COULD NOT BE RETRACTED. A PIECE OF THE DEVICE BROKE OFF AND STAYED ATTACHED TO THE MAIN COIL BODY WHEN MANIPULATING THE COIL. THE COIL AND PIECE OF DEVICE REMAINED PARTIALLY IN THE ILIAC. THE OVERALL END RESULT WAS DEEMED WELL ENOUGH. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15576126 ↗
• MalfunctionFeb 17, 2022Separation Failure; Separation Failure

  IT WAS REPORTED A FEMALE PATIENT REQUIRED A RETRACTA DETACHABLE EMBOLIZATION COIL FOR TREATMENT OF PELVIC CONGESTION. UPON OPENING THE PACKAGE, THE DEVICE WAS INTACT. THE COIL ADVANCED THROUGH THE SELECTIVE CATHETER WITHOUT DIFFICULTY. HOWEVER, DESPITE TURNING THE WIRE, THE COIL WAS IMPOSSIBLE TO DETACH FROM THE DELIVERY WIRE AND WOULD NOT DEPLOY. THE DEVICE WAS REMOVED AND INSPECTED AND NO DAMAGE WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. 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 13548946 ↗
• MalfunctionDec 27, 2021Separation Failure; Separation Failure

  ADDITIONAL INFORMATION WAS PROVIDED ON 27JAN2022. PRIOR TO THE USE OF THE COOK RETRACTA DETACHABLE EMBOLIZATION COIL FOR THE EMBOLIZATION OF A SEGMENTAL RIGHT BRANCH OF THE PORTAL VEIN, POLYVINYL ALCOHOL PVA WAS USED FOR DISTAL EMBOLIZATION. UPON OPENING THE PACKAGE OF THE COOK RETRACTA DETACHABLE EMBOLIZATION COIL, NO DAMAGE TO THE DEVICE WAS NOTED. THE PATIENT WAS DESCRIBED AS HAVING NORMAL ANATOMY AND NO SIGNIFICANT ANGULATION. THE PATIENT WAS NOT TAKING ANY ANTI-COAGULANT MEDICATION AT THE TIME OF THE PROCEDURE. THE TARGET VESSEL SIZE WAS APPROXIMATELY 10-12 MM. THE FIRST COIL DEPLOYED THROUGH THE CATHETER WAS A COMPETITORS COIL. THE CATHETER WAS FLUSHED WITH HEPARINIZED SALINE BEFORE THE DEPLOYMENT OF THE COOK RETRACTA DETACHABLE EMBOLIZATION COIL . THE COIL WAS NOT REPOSITIONED BEFORE DEPLOYMENT WAS ATTEMPTED. WHILE ADVANCING TO THE DELIVERY SITE, THE DEVICE WAS NOT ROTATED. THE PROVIDER STATED THAT MULTIPLE TURNS WERE MADE TO DETACH THE COIL. THE COIL WAS REMOVED AND ANOTHER COIL WAS DEPLOYED. AFTER THE REMOVAL OF THE COIL IT WAS REPORTED THAT THE COIL LOOKED "RELATIVELY OK." THE PATIENT DID NOT EXPERIENCE AN ADVERSE EVENT AS A RESULT OF THE FAILURE.

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

  MAUDE report 13089676 ↗
• 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 12632336 ↗
• MalfunctionMay 26, 2021Retraction Problem; Stretched; Difficult or Delayed Separation; Retraction Problem; Stretched; Difficult or Delayed Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11886809 ↗
• MalfunctionMar 25, 2021Separation Failure; Separation Failure

  IT WAS REPORTED A FEMALE PATIENT REQUIRED A RETRACTA DETACHABLE EMBOLIZATION COIL FOR OVARIAN VEIN EMBOLIZATION. DURING ATTEMPTED DEPLOYMENT, WITH THE JUNCTION ZONE CORRECTLY POSITIONED WITHIN THE TIP OF THE CATHETER, THE COIL WAS UNABLE TO BE UNSCREWED FROM THE DELIVERY WIRE. THREE OTHER COILS WERE PLACED WITHOUT DIFFICULTY. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRED ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11570979 ↗
• MalfunctionJan 12, 2021Separation Failure; Separation Failure

  IT WAS REPORTED A FEMALE PATIENT REQUIRED PLACEMENT OF RETRACTA DETACHABLE EMBOLIZATION COILS FOR AN EMBOLIZATION OF THE RIGHT RENAL ARTERY. DURING THE PROCEDURE, THE OPERATOR NOTED 3 RETRACTA COILS WERE NOT ABLE TO BE DEPLOYED. THE COILS COULD NOT DETACH FROM THE PUSHABLE WIRE AT THE TARGET SITE. ANOTHER SIMILAR DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. IT WAS NOTED THAT THE PATIENT HAD TORTUOUS ANATOMY. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE TWO 14X14 RETRACTA COILS ARE CAPTURED UNDER PATIENT IDENTIFIER NUMBER (B)(6) (THIS REPORT). THE ONE 14X18 RETRACTA COIL IS CAPTURED UNDER PATIENT IDENTIFIER NUMBER (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11156749 ↗
• MalfunctionJan 5, 2021Difficult 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 11120565 ↗
• 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 11102119 ↗
• MalfunctionFeb 3, 2020Separation Failure; Separation Failure

  IT WAS REPORTED AN UNKNOWN PATIENT REQUIRED PLACEMENT OF A RETRACTA DETACHABLE EMBOLIZATION COIL FOR EMBOLIZATION OF AN UNKNOWN ARTERY. THE OPERATOR REPORTED THAT "THE DETACHABLE COIL DID NOT RELEASE FROM THE WIRE INSIDE THE ARTERY." THE PHYSICIAN TRIED TO RELEASE IT ON THE TABLE AFTERWARDS AND "IT WAS STILL STUCK ON THE WIRE." AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9661674 ↗
• MalfunctionOct 8, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED ON 21NOV2018, IT WAS NOTED THAT THE DEVICE WAS DEPLOYED PREMATURELY OUTSIDE OF THE CATHETER. A SNARE WAS USED FROM THE SAME SITE TO TRY AND RETRIEVE THE COIL, BUT FAILED. ATTEMPTS WERE THEN MADE TO CONTRALATERALLY RETRIEVE THE COIL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7945339 ↗
• MalfunctionJun 21, 2018Material Frayed; Difficult 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. 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 7626644 ↗
• MalfunctionDec 1, 2016Material Separation; Stretched; Separation Failure; Material Separation; Stretched; Separation Failure

  IT WAS REPORTED THAT THE COIL WAS NOT ABLE TO DISCONNECT THE DELIVERY WIRE. IN THE END OF THE PROCEDURE THE USER FACILITY MANAGED TO GET THE WIRE LOSE, BUT THEN THE COIL WAS STRETCHED OUT IN THE VESSEL. THE USER FACILITY TRIED TO PUSH THE COIL BACK WITH THE CATHETER, BUT THEN THE COIL WAS STUCK ALONG THE CATHETER AND THE USER FACILITY COULD NOT TAKE THE CATHETER OUT OTHERWISE THE COIL WOULD MIGRATED AS WELL. AFTER AWHILE THE PHYSICIAN WAS ABLE TO GET THE CATHETER OUT WITH THE COIL STILL IN THE VENA OVARICA. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE

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

  MAUDE report 6139367 ↗