Tornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenous malformations and
FDA device recall Z-1762-2025 · posted 2025-05-14 · Open, Classified
Recall details
- Recalling firm
- Cook Incorporated
- Reason for recall
- Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil.
- Action taken
- An Urgent Field Safety Notice Medical Device Removal notification letter dated 4/17/25 was sent to customers. Actions To Be Taken by the User Identify Device(s) Quarantine Device(s) Return Device(s) to Cook Medical Other Please complete the enclosed Customer Reply Form. Where devices are indicated as being returned, our Customer Services department will contact you to organize the return and issue you with the relevant Returns Authorization number. Please include contact details on the Customer Reply form. Returned Device(s) should be addressed to: Cook Medical EUDC Robert-Koch-Strae, 2 52499 Baesweiler GERMANY Credit will be provided for the returned affected device(s) where applicable.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- KRD
- Quantity affected
- 2952 units
- Distribution
- worldwide - No US distribution.
- Date initiated
- 2025-04-17
- Date posted
- 2025-05-14
- Location
- Bloomington, IN
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