Angiographic Guidewire Component: Model Number: 107042, 107044, 107447, 110003, 110004, The angiographic guidewire compo

FDA device recall Z-1860-2021 · posted 2021-06-16 · Terminated

Recall details

Recalling firm

Medtronic Vascular

Reason for recall

The component part numbers intended for shipment to a third-party, where they are further processed into kits and sterilized were instead shipped directly to customers.

Action taken

In May, 2021, Medtronic issued an "URGENT: MEDICAL DEVICE RECALL" notice to customers via letter notifying them Medtronic is voluntarily recalling certain lots of Angiographic Guidewire components. In June 2021, Medtronic issued AMENDED URGENT MEDICAL DEVICE RECALL notices to customers. On The component part numbers associated with this recall are intended for shipment to a third-party, where they are further processed into kits and sterilized, but were instead shipped directly to customers. Actions: Medtronic records indicate that your facility has received one or more of the affected Angiographic Guidewire components. As a result, Medtronic requests that you immediately take the following actions: -Identify and quarantine all unused affected components identified in the customer letter. -Utilize standard hospital practice and policies to notify patients who were treated with the recalled components. -Return/Exchange all unused affected components in your inventory to Medtronic. Contact Medtronic Customer Service at 1-800-716-6700 to initiate a component return/exchange. Your local Medtronic Representative can assist you in the return of this component. Please refer to Table 2 for applicable part numbers to facilitate reordering. -Please complete the enclosed Customer Confirmation Form and email to rs.cfqfca@medtronic.com. This notice needs to be passed on to all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. If you have any questions regarding this communication, please contact your Medtronic Field Representative or call:763-526 -8583 or email: rs.cvgrecalls@medtronic.com.

Root cause

Component design/selection

Status

Terminated

Product code

NKQ

Quantity affected

54,997 units

Distribution

US /Domestic Distribution to states of: CA, KY, LA, MI, NE, NY, OH, OK, TX, WA, WI. OUS/Foreign to country of: Australia

Date initiated

2021-05-04

Date posted

2021-06-16

Date terminated

2023-01-05

Location

Danvers, MA