Retracta G34203Recalls & 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
- 6
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10827002342030), received between Feb 27, 2019 and Dec 5, 2024 — classified as 2 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Separation Failure” (2 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
- Separation Failure2
- Difficult or Delayed Separation1
- Material Fragmentation1
- Material Separation1
- Premature Separation1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient2
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
- Insufficient Information1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 5, 2024Difficult or Delayed Separation; Difficult or Delayed Separation
IN ADDITIONAL INFORMATION RECEIVED ON 03DEC2024, IT WAS REPORTED THAT THE JUNCTION ZONE WAS LOCATED OUTSIDE OF THE CATHETER DURING DEPLOYMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20854304 ↗MalfunctionAug 16, 2023Premature Separation; Premature Separation
ADDITIONAL INFORMATION WAS PROVIDED. IT WAS REPORTED THAT THE DELIVERY WIRE WAS FULLY LOADED INTO THE CATHETER. THE FULL LENGTH OF THE COIL WAS NOT ADVANCED OUT OF THE CATHETER; APPROXIMATELY A QUARTER TO A HALF OF THE COIL WAS OUT OF THE CATHETER. THE PHYSICIAN WAS ATTEMPTING TO GET THE COIL TO CURL INSTEAD OF THE COIL EXTENDING INTO AN ADJACENT VESSEL BRANCH. AS REPORTED, IT IS POSSIBLE THE DELIVERY WIRE WAS MANIPULATED IN ALTERNATING CLOCKWISE/COUNTERCLOCKWISE MOTIONS WHILE THE PHYSICIAN WAS TRYING GET THE COIL TO TAKE SHAPE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17557027 ↗InjuryMay 5, 2023Material 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; Insufficient Information
MAUDE report 16877135 ↗MalfunctionJan 12, 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 11156786 ↗MalfunctionJan 6, 2021Separation Failure; Separation Failure
IT WAS REPORTED A MALE PATIENT REQUIRED A RETRACTA DETACHABLE EMBOLIZATION COIL FOR A VARICOCELE PROCEDURE. THE DEVICE WAS ADVANCED INSIDE THE PATIENT TO THE TARGET SITE, BUT AFTER 20-30 TURNS THE COIL WOULD NOT DETACH FROM THE DELIVERY WIRE. REPORTEDLY, THE PHYSICIAN WAS UNABLE TO RETRACT THE DEVICE INTO THE CATHETER. DIFFICULT DETACHMENT OF THE COIL ALSO REPORTEDLY OCCURRED WITH 6 ADDITIONAL DEVICES OF THE SAME LOT PRIOR TO PATIENT CONTACT. 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 11126276 ↗InjuryFeb 27, 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 8375475 ↗
Other Device, Vascular, for Promoting Embolization devices
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- Azur CX Detachable 45-750824Microvention, Inc. · Device, Vascular, for Promoting Embolization115 reports
- Tornado G08261Cook Incorporated · Device, Vascular, for Promoting Embolization2 recalls7 reports
- Optima Coil System OPTI0930CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls4 reports
- Optima Coil System OPTI0720CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls4 reports
- Optima Coil System OPTI0413CSFMXBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
- Prestige Coil System PRES0520HPKPLBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
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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