Retracta G34199Recalls & reported problems
Cook Incorporated · Retracta Detachable Embolization Coil · Class 2 · Implant
All models of Retracta (15)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 19
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10827002341996), received between Mar 14, 2016 and Jan 21, 2025 — classified as 3 injuries, 16 malfunctions.
The most frequently reported specific device problem is “Difficult or Delayed Separation” (5 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.
Reports received per month
Most reported problems
Device problems
- Difficult or Delayed Separation5
- Premature Separation3
- Separation Failure3
- Unraveled Material2
- Break1
- Detachment Of Device Component1
- Difficult to Advance1
- Failure to Advance1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- No Known Impact Or Consequence To Patient5
- No Consequences Or Impact To Patient4
- Insufficient Information2
- Foreign Body In Patient1
- No Code Available1
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 21, 2025Difficult 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 21200657 ↗MalfunctionJan 20, 2025Unraveled Material; Unraveled Material
IN ADDITIONAL INFORMATION PROVIDED ON 23JAN2025, IT WAS REPORTED THAT THE JUNCTION ZONE WAS LOCATED JUST OUTSIDE OF THE CATHETER TIP DURING CATHETER DEPLOYMENT. THE USER STATED THAT WHEN DEPLOYING THE COIL, THE DELIVERY WIRE WAS ROTATED 10 TIMES COUNTERCLOCKWISE BUT MAY HAVE BEEN ROTATED CLOCKWISE A FEW TIMES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21193275 ↗MalfunctionSep 11, 2024Unraveled Material; Unraveled Material
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 20190531 ↗MalfunctionJan 2, 2024Premature Separation; Premature Separation
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
Patient problems: Insufficient Information
MAUDE report 18430953 ↗MalfunctionOct 11, 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: Insufficient Information
MAUDE report 17914791 ↗MalfunctionSep 8, 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 17715654 ↗InjuryDec 16, 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 13019620 ↗MalfunctionSep 17, 2021Difficult or Delayed Separation; Difficult or Delayed Separation
UPON DEVICE RETURN ON 13DEC2021, IT WAS NOTED THAT THE DISTAL END OF THE COIL HAD ELONGATED/UNRAVELED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12488877 ↗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 11117236 ↗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 11117054 ↗MalfunctionDec 4, 2020Difficult to Advance; Premature Separation; Difficult to Advance; Premature Separation
IT WAS REPORTED, AN UNKNOWN PATIENT REQUIRED THE PLACEMENT OF A RETRACTA DETACHABLE EMBOLIZATION COIL DURING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE. THE PHYSICIAN ATTEMPTED TO DEPLOY THE COIL IN THE TARGET SITE OF THE HYPERGASTRIC ARTERY, BUT "THE COIL GOT STUCK AT THE CANNULA" AND WOULD NOT COME OUT OF THE COIL DELIVERY SYSTEM. THE PHYSICIAN THEN PULLED THE COIL DEVICE OUT OF THE CATHETER. UPON ATTEMPTED DEPLOYMENT OF THE REPLACEMENT COIL, IT WAS DETERMINED THAT THE COIL HAD DEPLOYED IN THE CATHETER WITHOUT USE OF THE TORQUE DEVICE. THE CATHETER WAS REMOVED AND THE THIRD COIL WAS USED 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 10950023 ↗MalfunctionJul 30, 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 Known Impact Or Consequence To Patient
MAUDE report 10343713 ↗MalfunctionJun 15, 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 10153811 ↗MalfunctionJun 21, 2018Stretched
THE COMPLAINANT REPORTED THAT THE RETRACTA DETACHABLE EMBOLIZATION COIL BECAME STUCK IN THE CATHETER WHILE TRYING TO DETACH DURING EMBOLIZATION FOR VARICOCELES. THE DOCTOR FLUSHED A FEW TIMES AND WAS ABLE TO PULL THE COIL BACK. IT WAS FURTHER NOTED THAT 12CM (CENTIMETERS) OF THE COIL WAS STRETCHED. 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 7624951 ↗MalfunctionJun 20, 2018Failure to Advance
THE COMPLAINANT REPORTED THAT THE EMBOLIZATION COIL WOULD NOT ADVANCE THROUGH THE CATHETER. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. IT WAS FURTHER NOTED THAT THE COIL WAS STRETCHED AND KINKED IN SEVERAL PLACES. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7621263 ↗InjuryDec 4, 2017Fracture; Fracture
THE INTERNATIONAL CUSTOMER REPORTED THAT, WHEN THE RETRACTA DETACHABLE EMBOLIZATION COIL WAS EMPLOYED DURING A PORTAL EMBOLIZATION PROCEDURE ON (B)(6) 2017, THE COIL WOULD NOT DEPLOY PROPERLY. THE COIL APPEARED TO HAVE SHEARED OFF FROM THE CASING OF THE COIL UPON DEPLOYMENT. THE OPERATOR WAS ABLE TO RETRIEVE THE SHREDDED LENGTH OF COIL FROM THE SHEATH USING FORCEPS; THE WHOLE COIL COULD BE RETRIEVED. ALTHOUGH THE COIL TRAVELED ALONG THE CATHETER EASILY FOR THE MOST PART, AT ABOUT 5 CM FROM THE END OF THE CATHETER, A FIRM PUSH WAS REQUIRED TO ADVANCE THE COIL. THE PATIENT ANATOMY WAS NOT PARTICULARLY TORTUOUS. THE COIL WITH WHICH THE CUSTOMER REPORTEDLY ENCOUNTERED ISSUES WAS REPORTEDLY EITHER 1ST OR 2ND IN THE ORDER OF DEPLOYED COILS. THE DETACH JUNCTION WAS POSITIONED JUST OUTSIDE OF THE CATHETER WHEN THE DEPLOYMENT OF THE COIL WAS ATTEMPTED. NO FURTHER COILS WERE EMPLOYED IMMEDIATELY FOLLOWING THE COIL ISSUE, AS ACCESS WAS LOST DUE TO THE PRODUCT PROBLEM. THERE WAS NO PATIENT HARM REPORTED. THE PRODUCT HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, AS OF THE DATE OF THIS REPORT, THE INVESTIGATION IS STILL PENDING.
Patient problems: No Code Available
MAUDE report 7081719 ↗InjuryMar 29, 2017Break; Break
INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT WAS SCHEDULED TO UNDERGO AN ENDOVASCULAR AORTIC ANEURYSM REPAIR (EVAR). EMBOLIZATION OF THE PATIENT'S INTERNAL ILIAC ARTERY WAS INDICATED PRIOR TO THE EVAR. ONE RETRACTA DETACHABLE EMBOLIZATION COIL WAS SUCCESSFULLY DEPLOYED. A SECOND COIL APPEARED TO BECOME ENTANGLED IN THE FIRST COIL DURING DEPLOYMENT AND THE PHYSICIAN WAS UNABLE TO VISUALIZE THE JUNCTION ZONE OF THE COIL. ATTEMPTS TO DEPLOY THE SECOND COIL BY TURNING THE PIN VISE AND TO REMOVE THE DELIVERY WIRE WERE NOT SUCCESSFUL. THE PHYSICIAN NOTICED THAT THE DISTAL PART OF DELIVERY WIRE HAD SEPARATED LEAVING THE COIL, JUNCTION ZONE AND PART OF THE DELIVERY WIRE IN THE PATIENT'S ARTERY. THE COIL MASS WAS BALLOONED TO SET AND MAINTAIN PLACEMENT. THE PATIENT REPORTEDLY WILL UNDERGO EVAR WITH A COVERED STENT TO SHIELD THE EMBOLIZED PORTION OF THE INTERNAL ILIAC ARTERY. NO FURTHER PATIENT OR EVENT INFORMATION IS AVAILABLE. THE DEVICE WAS RETURNED FOR EVALUATION.
Patient problems: Foreign Body In Patient
MAUDE report 6443055 ↗MalfunctionMar 15, 2017Detachment Of Device Component; Detachment Of Device Component
CUSTOMER REPORTED THAT THE RETRACTA DETACHABLE EMBOLIZATION COIL FELL OFF OF THE WIRE WHEN THE DEVICE WAS BEING REMOVED FROM THE PACKAGE. THE EVENT OCCURRED PRIOR TO USE AND PRIOR TO PATIENT CONTACT. A REPLACEMENT DEVICE WAS OBTAINED TO PROCEED WITH THE PROCEDURE. THERE ARE NO REPORTED ADVERSE PATIENT CONSEQUENCES RELATED TO THIS EVENT. THE DEVICE IS NOT AVAILABLE FOR EXAMINATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6407691 ↗MalfunctionMar 14, 2016Material Separation; Material Separation
A (B)(6) FEMALE PATIENT WITH PSEUDOANEURYSM ON THE ANASTOMOSIS OF A BYPASS, LOCATION SIDE CIA/EIA WAS HAVING A COILING OF THE HYPOGASTRIC ARTERY TO PREVENT PSEUDOANEURYSM TO GROW THROUGH RETROGRADE FLOW OFTER COVERED STENT PLACEMENT PROCEDURE. THERE WAS UNSTABLE POSITIONING OF THE C2 CATHETER IN THE HYPOGASTRIC ARTERY; THEREFORE, A DECISION WAS MADE TO USE COOK RETRACTA DETACHABLE EMBOLIZATION COIL. THE FIRST 2 RETRACTA PLACEMENTS ( 6 AND 8MM ) WAS PLACED WITHOUT DIFFICULTIES. THE 10MM RETRACTA WAS ADVANCED; BUT FRICTION WAS FELT BY THE DOCTOR. WHEN HE TRIED TO REMOVE THE RETRACTA, THE COIL REMAINED INSIDE THE CATHETER (APPROXIMATELY 2CM WAS OUTSIDE THE CATHETER ) WHILE THE DELIVERY WIRE WAS OUT OF THE DISTAL END OF THE CATHETER AS THEY WERE SEPARATED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID REQUIRE ANY ADDITIONAL PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 5498223 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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