Urgent: Medical Device Product Recall Notice
Device: TREO® Abdominal Stent-Graft System
Certain Lots Manufactured to Date
May 08, 2023
Dear Valued Customer/Distributor,
Attention: All those implanting or managing affected patients
The purpose of this notice is to inform you that Terumo Aortic is voluntarily recalling specific lots of the Terumo Aortic TREO® Abdominal Stent-Graft Systems due to a potential issue with the affected products incorrectly containing a different-sized graft than expected. The TREO® Abdominal Stent-Graft System is a modular endovascular system designed to treat infrarenal abdominal aortic and aorto-iliac aneurysms.
Terumo Aortic has an investigation underway related to this issue and is currently working to determine the root cause and will take appropriate corrective action. Terumo Aortic has conducted an internal investigation and tracked the affected lots to a narrow time frame resulting from a specific manufacturing event detailed in the table below.
The potential hazard of dimension discrepancies between the package and the actual stent-graft is the risk of implanting an oversized or undersized device that may not fit the patient’s anatomy; therefore, not addressing the therapeutical goals aimed by the physician. To date, Terumo Aortic has not received any reports of adverse events related to this issue. There is no safety concern for patients that have already been treated successfully using product from these lots. Patients should be managed according to standard clinical practice. There are no specific patient monitoring instructions related to this Field Safety Corrective Actions that are recommended beyond the existing follow-up schedule.
Actions to be taken by the Customer/User:
- Examine your inventory to confirm whether you have any affected product and immediately quarantine all impacted items.
- Complete the attached Acknowledgement Form. It may be that you no longer have any physical inventory on site. Completing the form will allow us to update our records and will also negate the need for us to send any further communications on this matter.
a. Therefore, please complete the form even if you no longer have any affected product in your physical inventory.
b. Note: Terumo Aortic authorizes its customers to utilize electronic signatures and email delivery as a means of submitting necessary documents.
- Return all affected product to a Terumo Aortic sales representative.
- Retain a copy of the signed Acknowledgement Form and this Field Safety Notice in the event of a compliance audit of your facility’s documentation. The names of user facilities notified are routinely provided to the Competent Authorities for audit purposes.
- Please inform Terumo Aortic of any adverse events concerning the use of the affected product.
a. Please comply with any local laws or regulations concerning the notification of adverse events to your local distributor or Competent Authority if appropriate.
If you have any questions regarding this recall, please contact your local sales representative or firstname.lastname@example.org.
Product and Distribution Information
See Table in pdf file below for the affected product list.
TMC is committed to providing our customers with high-quality, effective medical devices. We take this commitment seriously and understand that on rare occasion, corrective actions such as this recall may be necessary to uphold that commitment.
Thank you for choosing to do business with TMC and we apologize for any inconvenience this action may cause you.
Transmission of this Notice
Forward this notice to all those who need to be aware within your organization such as risk managers and hospital administration, as well as any organization where the potentially affected product has been transferred. Please maintain awareness of this notice and resulting action for an appropriate period to ensure effectiveness of the corrective action.
This correction is being made with the knowledge of the Food and Drug Administration. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.
Click here to few the complete notice with the product listings.