Oman Ministry of Health Circular No. 11/2025

Recall of EOPA™ Elongated One-Piece Arterial Cannula from Medtronic, Inc.

Source

SFDA- Saudi Food & Drug Authority.

https://ade.sfda.gov.sa/Fsca/PublishDetails/234

Product

EOPA™ Elongated One-Piece Arterial Cannula.

Manufacturer

Medtronic, Inc.

Local agent

AL Zahrawi Medical Supplies

The affected products

Product Description: EOPA™ Arterial Cannula

Model Number: 77418.

Lot Number : 2022041038.

Correct Labelling: Box should be: 77418, Pouch should be: 77418, Cannula should be: 18 Fr.

Discrepancy: Cannula might be: 22 Fr.

Reason

Products for the models listed above were incorrectly labelled with an incorrect size.

Action

  1. Immediately identify and quarantine all unused, listed product in your inventory.

  2. Return unused, listed product in your inventory to Medtronic.

  3. Contact the local agent for remedial action.

comments

Healthcare professionals are encouraged to report any adverse events Suspected to be associated with the above device or any other medical device to Department of Medical Device Control through the E-mail: vigilance-md@moh.gov.om

Dr. Mohammed Hamdan Al Rubaie

Director General

To:

THE DIRECTOR GENERAL OF HEALTH SERVICES IN ALL GOVERNORATES

Commanding Officer, Armed Forces Hospital (Al Khoudh & Salalah)

Director General of Engineering Affairs, MOH

Director General of Royal Hospital

Director General of Khoula Hospital