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ev3 Inc. Recall 89470

Description: Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature.

ev3 Inc. Recall 89470 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0695-2022
Event ID89470
Event DescriptionMedtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature.
Product TypeDevices
DistributionUS Nationwide distribution in the states of AZ, CA, FL, IA, IL, KS, LA, MI, MS, NC, NJ, NY, OR, SC, SD, TN, TX, and VA.
Quantity245 devices
Recall ReasonThe device has similarities in design to another device that the firm recently issued a field correction on due to instances of tip detachment and embolization.
Device Classification20220316
Device Code InfoGTIN 00763000402419
Center Classification Date20220307
Recall Initiation Date20220204
Recalling Firmev3 Inc.
Initial Notification Letter
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