Tornado Embolization Microcoil, RPN GPN MWCE-18S-5/2-TORNADO G08356 MWCE-18S-6/2-TORNADO G08259 MWCE-18S-3/2-TORNADO-01 G47416 MWCE-18S-4/2-TORNADO-01 G47417 MWCE-18S-3/2-TORNADO-081800 G13102 MWCE-18S-3/2-TORNADO G08261 MWCE-18S-4/2-TORNADO-081800 G13103 MWCE-18S-4/2-TORNADO G08357 MWCE-18S-5/2-TOR
Check against the official notice below — it lists the full affected range.
Cook Incorporated is recalling Tornado Embolization Microcoil devices across multiple product codes due to a manufacturing defect. The loading cartridges included with these devices may contain a small, unintended stainless-steel cannula. The recall affects 106,033 units distributed nationwide in the United States and worldwide internationally, spanning numerous lot numbers.
The source document does not specify a remedy or recommended action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.
Reason for recall: The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula. Distribution: Domestic distribution nationwide. Foreign distribution worldwide. Quantity: 106,033 Lot/code info: Lots: 14220596 14220940 14266927 14266928 14266929 14266930 14266931 14270156 14270688 NS14220942 14173005 14173006 14173009 14174725 14183341 14183343 14183344 14183345 14183346 14183347 14185759 14185762 14185763 14185764 14185765 NS14183348 14144260 14144261 14149518 14151428 14165309 14176799 14176801 14176802 14176804 14181260 14181262 14181263 14195340 14195341 14195342 14198726 14198727 14198728 14198729 14198730 14198731 14198732 14202396 14202397 14202398 14205449 NS14202553 14149487 14158173 14159388 14173007 14202382 14205450 14208005 14208006 14208007 14208008 14208009 14210749 14210750 14210751 NS14202380 NS14202381 14158174 14159387 14181258 14181259 14188217 14188363 14188366 14195343 14195344 14195345 14196666 14196669 14202556 14210752 14210753 14210754 14212795 14212796 14212797 14212798 14212800 14212801 14212802 14215747 NS14188216 NS14188218 NS14188219 NS14212799 14250738 14250742 14250743 14253965 14254863 14254864 14254865 14254866 14254867 14236671 14236672 14236673 14236674 14236675 14239466 14239467 14239468 14239469 14239470 14239471 14239472 14242269 14242270 14242271 14242272 NS14242268 14195265 14195266 14196667 14196668 14198997 14202554 14220941 14224113 14224114 14224115 14224116 14224117 14230375 14230376 14230379 14236670 14258545 14261429 14261430 14261431 14261432 14261433 14261434 14261435 NS14220945 NS14227791 14198998 14202555 14215746 14215748 14215749 14215750 14215751 14215752 14221686 14221687 14221688 14221689 14227792 14227793 142
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.