Retracta G34191Recalls & 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
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002341910), received between Jan 18, 2022 and Apr 11, 2023 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Migration” (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 16, 2026.
Most reported problems
Device problems
- Migration1
- Separation Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Chest Pain1
- Insufficient Information1
- Swelling/ Edema1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 11, 2023Separation Failure; Separation Failure
IN ADDITIONAL INFORMATION RECEIVED ON 27APR2023, IT WAS CONFIRMED THAT THE CATHETER WAS FLUSHED PRIOR TO EACH COIL DEPLOYMENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16716209 ↗MalfunctionJan 18, 2022Migration; Migration
IT WAS REPORTED AN UNKNOWN PATIENT HAD RETRACTA DETACHABLE EMBOLIZATION COILS AND MREYE EMBOLIZATION COILS PLACED. FOURTEEN MONTHS AFTER PLACEMENT, THE PATIENT UNDERWENT A SCAN AND IT WAS DISCOVERED THE COILS MIGRATED TO THE PULMONARY ARTERY. THE PATIENT IS ASYMPTOMATIC. ADDITIONAL INFORMATION INCLUDING EVENT DETAILS AND FURTHER PATIENT INFORMATION AND OUTCOME HAVE BEEN REQUESTED, BUT ARE CURRENTLY UNKNOWN. THE REPORTS WITH THE FOLLOWING PATIENT IDENTIFIERS CAPTURE THE COILS INVOLVED IN THIS INCIDENT: (B)(6).
Patient problems: Chest Pain; No Clinical Signs, Symptoms or Conditions; Swelling/ Edema
MAUDE report 13285184 ↗
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- 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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