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Endurant Stent Graft System recallZ-0290-2022 · Medtronic Vascular, Inc. · initiated Oct 15, 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 spindle may detach from the distal end of the spindle hypotube

FDA root cause category: Under Investigation by firm

What the company is doing

On or about 10/15/2021, the firm initiated a global verbal notification to customers informing them that is the potential for a specific subset of 18Fr Stent Graft Systems to have the potential for the spindle to detach from the spindle hypotube during deployment. On 10/18/2021, the firm sent an "URGENT MEDICAL DEVICE RECALL" Notification Letter via UPS 2-day delivery. Customers are instructed to take the following actions: 1) Return all unused affected devices to the Recalling Firm 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 Recall notice to all those who need to be aware within their organization to include physician implanters (US only). Additionally, if any affected devices have been distributed to other organizations, forward this notice to those entities. For questions or assistance - contact their Field Representative or Customer Service at 888-283-7868 or email [email protected].

Recall details

Recall number
Z-0290-2022
Status
Open, Classified
Initiated by the company
Oct 15, 2021
Recalling firm
Medtronic Vascular, Inc.
Quantity
2 devices
Product code
MIH
FDA submissions
P100021
Distribution
Worldwide distribution - U.S. Nationwide distribution in the states of CA, FL, GA, MN, MO, NC, NJ, NM, NV, NY, PA, SC, TN, TX, VA, and WV. The countries of Austria, Belgium, Bulgaria, China, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Japan, Jordan, Lithuania, Luxembourg, Netherlands, Norway, Poland, Portugal, Qatar, South Africa, Spain, Sweden, Switzerland, and United Kingdom.

Product description

Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE

Code information (models, lots, serial numbers)

Model Number/Product Descripton: ENTF2525C70EE/STENT GRAFT ENTF2525C70EE ENDURANT TUBE GTIN Code: 00763000006129 Serial Numbers: V30624638 V30624639

Other devices under the same FDA submission

170 devices cleared under P100021 — the recall does not name any of them by identifier. 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 88951).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page