Retracta G34187Recalls & reported problems
Cook Incorporated · Retracta Detachable Embolization Coil · Class 2 · Implant
All models of Retracta (15)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002341873), received between Dec 4, 2017 and Oct 10, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Detachment Of Device Component” (1 report).
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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment Of Device Component1
- Migration1
- Premature Separation1
- Separation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Patient Involvement1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 10, 2024Migration; Migration
THIS EVENT NO LONGER MEETS THE QUALIFICATIONS FOR A REPORTABLE EVENT. SEE H10.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20423304 ↗MalfunctionOct 9, 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: No Clinical Signs, Symptoms or Conditions
MAUDE report 20409681 ↗MalfunctionOct 1, 2021Separation Failure; Separation Failure
IT WAS REPORTED THAT A RETRACTA DETACHABLE EMBOLIZATION COIL DID NOT DETACH FROM THE WIRE DURING A FISTULA EMBOLIZATION PROCEDURE. OVER 10 TURNS WERE PERFORMED IN AN ATTEMPT TO DETACH THE COIL. THOUGH THE COIL DID NOT DETACH, THE EMBOLIZATION WAS SUCCESSFULLY COMPLETED. THERE HAVE BEEN NO COMPLICATIONS TO THE PATIENT, AND NO ADDITIONAL PROCEDURES COMPLETED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12565131 ↗MalfunctionDec 4, 2017Detachment Of Device Component; Detachment Of Device Component
THE CUSTOMER REPORTED THAT, DURING A PRODUCT DEMONSTRATION, UPON THE OPENING OF THE RETRACTA DETACHABLE EMBOLIZATION COIL, THE COIL DETACHED FROM THE DELIVERY WIRE AS THE WIRE WAS PUSHED OUT OF THE METAL CANNULA FOR THE FIRST TIME. THE WIRE WAS REPORTEDLY NOT TORQUED, AND THE COILS WERE NOT HELD ON TO WHILE THE WIRE WAS ADVANCED. THE CUSTOMER CONFIRMED THAT THE DEVICE WAS NOT USED; ACCORDINGLY, NO PATIENT ADVERSE EVENTS OCCURRED AS A RESULT OF THE PRODUCT ISSUE. THE PRODUCT IS REPORTEDLY UNAVAILABLE FOR RETURN AND EVALUATION.
Patient problems: No Patient Involvement
MAUDE report 7081658 ↗
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
- Prestige Coil System PRES0520HPKPLBalt USA LLC · Device, Vascular, For Promoting Embolization2 recalls3 reports
- Optima Coil System OPTI0413CSFMXBalt 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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