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Open, Classified

Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and peripheral venous thrombectomies.

FDA Recall Z-1824-2024 · Posted 2024-05-15

Recalling FirmLeMaitre Vascular, Inc.
Recall StatusOpen, Classified
Product CodeDXE
Date Initiated2024-04-17
Product Quantity5,604 units

Reason for Recall

The guide tip can become damaged and result in the tip detaching.

Firm Action

Consignees were mailed an URGENT MEDICAL DEVICE RECALL Notification, dated 4/10/2024. The notification instructs consignees to inspect their inventory for and quarantine affected devices, complete and return the provided Response Form to [email protected], and return affected devices for credit. If product was further distributed, the recall notification is to be forwarded for customer awareness. Consignees with any questions are to contact Rose Lerer at [email protected] from Monday through Friday, 8:00 AM to 4:30 PM EST.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Australia, Canada, and Spain.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K910372INTIMAX THROMBECTOMY CATHETERApplied Vascular Devices, Inc. · 1991-04-26

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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