Retracta G34202Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10827002342023), received between Aug 23, 2016 and Jan 20, 2025 — classified as 2 injuries, 9 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 20, 2025Break; Unraveled Material; Break; Unraveled Material

  ADDITIONAL INFORMATION WAS RECEIVED ON 21JAN2025: 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. THERE WAS AN ANEURYSM IN THE RIGHT COMMON 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, THE COIL WAS FOUND TO BE STRETCHED AND BROKE DURING REMOVAL. THE COIL WAS ROTATED BOTH CLOCKWISE AND COUNTERCLOCKWISE, RESULTING IN ITS FAILURE TO DEPLOY. THE PATIENT WAS UNDER ANTICOAGULANT THERAPY, AND THE PATIENT WAS ON EMBOLIC TREATMENT FOR IMA (INFERIOR MESENTERIC ARTERY) EMBOLIZATION. THE PHYSICIAN FLUSHED THE CATHETER BEFORE EACH ATTEMPT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21194163 ↗
• MalfunctionJan 22, 2024Unraveled Material; Difficult or Delayed Separation; Unraveled Material; 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 18553264 ↗
• MalfunctionOct 20, 2023Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT A RETRACTA DETACHABLE EMBOLIZATION COIL WOULD NOT DETACH. DURING A RENAL ARTERY ANEURYSM EMBOLIZATION PROCEDURE, THE COIL DID NOT DEPLOY. THE DEVICE WAS SUBSEQUENTLY REMOVED FROM THE PATIENT. 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 17975398 ↗
• 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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17835260 ↗
• 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 17834443 ↗
• 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 12632067 ↗
• MalfunctionMar 12, 2021Premature 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 11476975 ↗
• MalfunctionJan 6, 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 11124781 ↗
• MalfunctionMar 11, 2020Premature Separation; Premature Separation

  ADDITIONAL INFORMATION RECEIVED 08MAY2020: THE OPERATOR REPORTS THAT THEY DID FLUSH THE CATHETER BEFORE COIL DEPLOYMENT, "PER STANDARD PROCEDURE." IT WAS REPORTED THAT THE COIL REMAINED IN THE TARGETED AREA AND "BY PARKING IT ANOTHER COIL, IT CAME LOOSE". THE COIL WAS NOT RETRIEVED AND REMAINS IN THE PATIENT. IT WAS ALSO REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9818811 ↗
• InjuryMar 9, 2020Material Separation; Separation Failure; Material Separation; Separation Failure

  ADDITIONAL INFORMATION RECEIVED ON 08MAY2020 INDICATED THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 9805707 ↗
• MalfunctionAug 23, 2016Unraveled Material; Unraveled Material

  IT WAS REPORTED THAT AN (B)(6) MALE UNDERWENT A TESTICULAR VEIN EMBOLIZATION PROCEDURE. THE SHEATH, CATHETER AND WIRE WERE POSITIONED IN THE INTERNAL ILIAC VEIN AND A RUN WAS PERFORMED. THE VESSEL MEASURED 14MM IN DIAMETER. THE VASCULAR SURGEON ASKED FOR THE 16MM DETACHABLE COIL. THE COIL TRACKED NICELY UP FROM THE RIGHT SIDE INTO THE LEFT INTERNAL ILIAC VEIN. THE SURGEON PROCEEDED TO DETACH THE COIL IN COUNTER CLOCKWISE POSITION AND KEPT REPEATING THIS WITHOUT THE COIL DETACHING. IT WAS THEN RECOMMENDED THAT HE PULL BOTH THE COIL AND CATHETER OUT TOGETHER. UPON INSPECTION IT WAS NOTICED THE INCONEL HUB WAS STILL INTACT, ALTHOUGH THE WIRE HAD LOOKED TO UNRAVEL. NO ADDITIONAL PROCEDURE WAS REQUIRED AND THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5895966 ↗