Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1-S-INT, Small Vessel, 6F (2.2 mm) Recommend

FDA device recall Z-0451-2022 · posted 2022-01-19 · Terminated

Recall details

Recalling firm

ev3 Inc.

Reason for recall

Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.

Action taken

The firm, Medtronic, issued an "URGENT MEDICAL DEVICE NOTICE" dated December 2021 on 12/6/2021 via 2-day UPS delivery to consignees who have the affected product. Outside of the United States, beginning 12/6/2021, the letter was being delivered via regionally-approved methods to the consignees. The letter describe the product, problem and actions to be taken. The consignees were instructed to do the following The letters The letter reiterates the existing warnings and precautions in the HawkOne Instructions for Use (IFU) related to the risk associated with tip damage caused by guidewire prolapse. The consignee is informed reports have been received of tip damage during use of 6Fr HawkOne devices which has resulted in some instances of tip detachment and embolization. The consignees are informed that no updates will be applied to the current HawkOne IFU at this time and patients should continue to be monitored per the practice's normal follow-up procedures. There are no actions required for patients where HawkOne was previously used during a procedure and there are no product retrievals or disposals requested by Medtronic. Customer Instructions provided in the letter include the following actions be immediately taken: (1) Share with all those who need to be aware within their organization or to any organization where the products have been transferred; (2) Prior to use, the IFU is to be reviewed noting the warnings and precautions listed in this letter; and (3) The enclosed Customer Confirmation Form is to be completed and emailed to the recalling firm. The confirmation form is for the customer to sign and date to acknowledge receipt of the enclosed letter and email to: rs.cfqfca@medtronic.com. If you have any questions regarding this issue or communication, please contact your Medtronic Field Representative or email: rs.recalls@medtronic.com.

Root cause

Labeling design

Status

Terminated

Product code

MCW

Quantity affected

28,094 units

Distribution

Worldwide Distribution: US (nationwide), including PR; and Foreign distribution to countries of: Argentina, Australia, Austria, Belgium, Brazil, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Rep

Date initiated

2021-12-06

Date posted

2022-01-19

Date terminated

2024-10-02

Location

Plymouth, MN

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