Tornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenous malformations and other vascular lesions, RPN MWCE-18S-3/2-TORNADO (GPN G08261), RPN MWCE-18S-3/2-TORNADO-081800 (GPN G13102), RPN MWCE-18S-4/2-TORNADO (GPN G08357)
Reported: May 21, 2025 Initiated: April 17, 2025 #Z-1762-2025
Product Description
Tornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenous malformations and other vascular lesions, RPN MWCE-18S-3/2-TORNADO (GPN G08261), RPN MWCE-18S-3/2-TORNADO-081800 (GPN G13102), RPN MWCE-18S-4/2-TORNADO (GPN G08357)
Reason for Recall
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil.
Details
- Recalling Firm
- Cook Incorporated
- Units Affected
- 2952 units
- Distribution
- worldwide - No US distribution.
- Location
- Bloomington, IN
Frequently Asked Questions
What product was recalled? ▼
Tornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenous malformations and other vascular lesions, RPN MWCE-18S-3/2-TORNADO (GPN G08261), RPN MWCE-18S-3/2-TORNADO-081800 (GPN G13102), RPN MWCE-18S-4/2-TORNADO (GPN G08357). Recalled by Cook Incorporated. Units affected: 2952 units.
Why was this product recalled? ▼
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 21, 2025. Severity: Moderate. Recall number: Z-1762-2025.
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