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Endurant II recallZ-2135-2021 · Medtronic Vascular, Inc. · initiated Jun 7, 2021

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic Vascular, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

During stent graft deployment, the radiopaque (RO) marker bond detached from the distal end of the graft cover.

FDA root cause category: Under Investigation by firm

What the company is doing

On 06/07/2021, the firm initiated a verbal notification regarding an "URGENT MEDICAL DEVICE RECALL" which informed customers that Earlier this week, Medtronic identified the potential for a specific subset of 20Fr Endurant II/IIs Stent Graft Systems to have the potential for the Radiopaque Marker to detach during deployment. There is evidence that devices that used one batch of graft cover subassemblies has a higher potential to exhibit this failure mode. This is an acute failure of the delivery system, there are no concerns with previously implanted stent grafts. We are requesting that you immediately refrain from using this specific subset of products and place it in quarantine until further notice. You will be receiving an official recall notice with instructions for product return for credit or replacement. Your Sales Representative will assist you with this process. We apologize for the inconvenience; however, this action is necessary to ensure the utmost patient safety with the use of our products. On 06/18/2021, the firm sent an "URGENT MEDICAL DEVICE RECALL" Notification Letter via UPS 2-Day delivery that restated the verbal notification. The Customer Notification Letter instructed customers to: 1)Return all unused affected devices via their sales representative or calling customer service at 1-888-283-7868 or email [email protected]. 2)Complete the enclosed Customer Confirmation Form and email to [email protected]. 3)Forward this notice to all those who need to be aware within their organization. For questions or assistance, contact Customer Service at 1-888-283-7868.

Recall details

Recall number
Z-2135-2021
Status
Open, Classified
Initiated by the company
Jun 7, 2021
Recalling firm
Medtronic Vascular, Inc.
Quantity
18 devices
Product code
MIH
FDA submissions
P100021
Distribution
U.S.: GA, MA, MD, NY, SC, TX, WA, and WV O.U.S.: Argentina, Australia, Germany, Greece, Israel, Italy, Netherlands, Poland, South Africa, Spain, Switzerland and United Kingdom.

Product description

Endurant II/Endurant IIs Stent Graft System: Medtronic Endurant II Stent Graft System REF ETUF3214C102EE, ETCF3636C49EE, ETBF3216C166EE, and ETUF3614C102E. Used to treat infrarenal abdominal aortic or aortoiliac aneurysms using an endovascular approach.

Code information (models, lots, serial numbers)

Endurant II Stent Graft System: Model (REF): ETCF3636C49EE GTIN: 00763000099626 Serial Numbers: V29778214; V29778215; Model (REF): ETUF3214C102EE GTIN: 00643169780958 Serial Numbers: V29775791; V29775792; V29775793; V29775794; V29775795; Model (REF): ETBF3216C166EE GTIN: 00763000099626 Serial Numbers: V29778214; V29778215; Model (REF): ETUF3614C102E GTIN: 00643169232631 Serial Numbers: V29781886 V29781883 V29781889 V29781887 V29781890 V29781891 V29781882

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

169 devices cleared under P100021 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 88158).

Sources and updates

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