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Heli-FX EndoAnchor System recallZ-3227-2017 · Medtronic Vascular, Inc. · initiated Sep 13, 2017

Terminated

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

It was determined that the deflection length indicated on the Guide catheter handle does not match the label on the box and sterile packaging for two lots.

FDA root cause category: Labeling Change Control

What the company is doing

The firm initiated their recall on September 13, 2017, by letter. The letter requested the consignee take the following actions: "1. Identify and quarantine all unused affected product as listed in your inventory. 2. Return all unused affected list product in your inventory to Medtronic. Contact Medtronic Customer Service at 1-800-854-3570 to initiate a product return and credit. Your local Medtronic Representative can assist you in the return and replacement of this product as necessary. 3. Complete the enclosed Customer Confirmation Certificate and fax it to Medtronic at 651-367-0612 to the attention of Customer Focused Quality or scan and email to RS.CFQFCA@medtronic .com. This notice needs to be passed on to all those who need to be aware within your organization where the potentially affected devices have been transferred." For further questions, please call (508) 261-8000.

Recall details

Recall number
Z-3227-2017
Status
Terminated
Initiated by the company
Sep 13, 2017
Recalling firm
Medtronic Vascular, Inc.
Quantity
20 units
Product code
OTD
FDA submissions
K171427
Distribution
US Distribution to the states of : AZ, CA, FL, GA, MA, MI, MN and NH.

Product description

Medtronic Aptus Heli-FX Thoracic EndoAnchor System Heli-FX Guide 42 mm, REF HG-18-90-42, STERILE EO, Rx Only The Heli-FX EndoAnchor System is intended to provide fixation and sealing between endovascular aortic grafts and the native artery. The Heli-FX System is indicated for use in patients who endovascular grafts have exhibited migration or endoleak, or are at risk for such complications, in whom augmented radial fixation and or sealing is required or regain or maintain adequate aneurysm exclusion.

Code information (models, lots, serial numbers)

UDI 00763000006679, Lot Number 0008674156 UDI 00763000006655, Lot Number 0008674157

Devices named in this recall

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

Product lines

Other devices under the same FDA submission

11 devices cleared under K171427 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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