—#186433

Product

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 product code: QAN — Stent, Iliac Vein
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P200026
Affected lot / code info: UDI 00643169796348, Lot Number B086915

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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.

Recalling firm

Firm: Medtronic Inc.
Address: 4600 Nathan Ln N, Plymouth, Minnesota 55442-2890

Distribution

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

Timeline

Recall initiated: 2021-03-16
Terminated: 2024-04-15
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #186433. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.