Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Medtronic Abre Venous Self-expanding Sent System, Catalog number REF AB9U16080090 - Product Usage: intended for use in the iliofemoral veins for the treatment of symptomatic venous outflow obstruction.

FDA Recall Z-1532-2021 · Posted None

Recalling FirmMedtronic Inc.
Recall StatusTerminated
Product CodeQAN
Date Initiated2021-03-16
Date Terminated2024-04-15
Product Quantity23 devices

Reason for Recall

Incorrect size printed on the device; packaging is labeled correctly.

Firm Action

Beginning 16-Mar-2021, Medtronic initiated verbal communications to consignees in possession of affected units. Consignees were advised to quarantine all affected units within their possession, pending retrieval. A written Medical Device Correction letter was mailed on 03/30/2021 via UPS 2-day delivery to consignees who have received affected product according to Medtronic records. Consignees will be asked to complete and return a confirmation certificate, confirming they have received the notification. Consignees are also asked to return all unused, affected product within their possession.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution in the states of NC, CO, CA, AZ, MT, MO.

Official Source

View FDA Recall →

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

↑