Home / Recalls / Cook Incorporated / Z-1762-2025

Z-1762-2025 Class II Ongoing

Recalled by Cook Incorporated — Bloomington, IN

Recall Details

Product Type
Devices
Report Date
May 21, 2025
Initiation Date
April 17, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2952 units

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.

Distribution Pattern

worldwide - No US distribution.

Code Information

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

Other recalls by Cook Incorporated

  • Z-0994-2026 Class II — Ring Transjugular Intrahepatic Access Sets, Reference Part Numbers: 1) RTPS-1 (November 26, 2025)
  • Z-0993-2026 Class II — Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0-18 (November 26, 2025)
  • Z-0995-2026 Class II — R¿sch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100; (November 26, 2025)
  • Z-1902-2025 Class I — Beacon Tip 5.0 Fr Angiographic catheters are designed to facilitate diagnostic a (May 15, 2025)
  • Z-1786-2025 Class II — Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10. (April 17, 2025)
  • Z-1787-2025 Class II — Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14. (April 17, 2025)
  • Z-0499-2025 Class II — Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789 (October 14, 2024)
  • Z-0346-2025 Class II — Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference Part (October 8, 2024)
  • Z-0347-2025 Class II — Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numbers (October 8, 2024)
  • Z-0045-2025 Class II — Check-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order (September 16, 2024)