Cook Incorporated: 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)

Hazard

Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil.

Details from the source

Reason for recall: Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil. Distribution: worldwide - No US distribution. Quantity: 2952 units Lot/code info: MWCE-18S-3/2-TORNADO, UDI-DI: 00827002082618, Lot Numbers: 16183145 16183146 16194351 16196532 16196533 16197253 NS16188093 NS16192163 16196534 16196535 16197247 16197248 16197249 16197250 16197251 16197252 16204238 NS16199061 16233647 16233648 16233649 NS16233646; MWCE-18S-4/2-TORNADO, UDI-DI: 00827002083578, Lot Numbers: 16178639 16181782 16181783 16181784 16186101 NS16178638; MWCE-18S-3/2-TORNADO-081800, UDI-DI: 00827002131026, Lot Numbers: 16188094 16188095

UPC codes

00827002082618, 00827002083578, 00827002131026

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.