Z-3227-2017Class II

Medtronic Aptus Heli-FX Thoracic EndoAnchor System Heli-FX Guide 42 mm, REF HG-18-90-42, STERILE EO, Rx Only...

Name: Z-3227-2017 Medtronic Aptus Heli-FX Thoracic EndoAnchor System Heli-FX Guide 42 mm, REF HG-18-90-42, STERILE EO, Rx Only...
Creator: Medtronic Vascular, Inc.
Published: 2017-09-13
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2017-09-13 / Terminated / root cause: labeling and UDI

FDA source

Medtronic Vascular, Inc. began a recall of 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... on 2017-09-13. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-3227-2017
Classification: Class II
Status: Terminated
Initiated: 2017-09-13
Posted: 2017-09-27
Terminated: 2020-05-18
Recalling firm: Medtronic, Inc.
Product: 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.
Product code: OTD Endovascular Suturing System
Reason for recall: 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.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: 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.
Quantity in commerce: 20 units
Distribution: US Distribution to the states of : AZ, CA, FL, GA, MA, MI, MN and NH.
Product codes and lots: UDI 00763000006679, Lot Number 0008674156 UDI 00763000006655, Lot Number 0008674157

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3227-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3227-2017	Class II	Terminated	Voluntary: Firm initiated	2017-10-04	2017-09-27

Product code OTD

K171427Class IIHeli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor CassetteMedtronic Vascular, Inc. / cleared 2017-06-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)