Z-2546-2016Class II

Medtronic EnVeo R Delivery Catheter System (DCS), Models: ENVEOR-L, ENVEOR-L-C, and ENVEOR-US. Designed to...

Name: Z-2546-2016 Medtronic EnVeo R Delivery Catheter System (DCS), Models: ENVEOR-L, ENVEOR-L-C, and ENVEOR-US. Designed to...
Creator: Medtronic Cardiovascular Surgery-the Heart Valve Division
Published: 2016-08-03
License: https://open.fda.gov/license/

Medtronic Heart Valves Division / initiated 2016-08-03 / Terminated / root cause: design

FDA source

Medtronic Cardiovascular Surgery-the Heart Valve Division began a recall of Medtronic EnVeo R Delivery Catheter System (DCS), Models: ENVEOR-L, ENVEOR-L-C, and ENVEOR-US. Designed to replace the native or surgical bioprosthetic aortic... on 2016-08-03. FDA classified it as Class II and gives the reason as "Potential for vascular trauma with the use of the Medtronic EnVeo R Delivery Catheter System (DCS)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2546-2016
Classification: Class II
Status: Terminated
Initiated: 2016-08-03
Posted: 2016-08-16
Terminated: 2017-03-31
Recalling firm: Medtronic Heart Valves Division
Product: Medtronic EnVeo R Delivery Catheter System (DCS), Models: ENVEOR-L, ENVEOR-L-C, and ENVEOR-US. Designed to replace the native or surgical bioprosthetic aortic heart valve without open heart surgery and without concomitant surgical removal of the failed valve.
Product code: NPT Aortic Valve, Prosthesis, Percutaneously Delivered
Reason for recall: Potential for vascular trauma with the use of the Medtronic EnVeo R Delivery Catheter System (DCS).
Root cause tag: design
FDA root cause: Device Design
Action: Firm initiated a recall on 8/3/16 by sending an Urgent Medical Device Correction letter to inform them of the potential for vascular trauma with the use of the Medtronic EnVeo R Delivery Catheter System (DCS). The letter informs the customers of the recommendations to reduce the rate of vascular trauma events and the procedural uses. The letter informs the customers that the Evolut R System Instructions for Use (IFU) will also be updated appropriately consistent with the Dear Doctor communication. Patients with questions can contact Medtronic Cardiovascular Patient Services at 877-526-7890 (Monday-Friday, 7:30am-5pm Central Time). Customers with any questions are instructed to contact their Medtronic Field Representative or Lifeline Technical Services at 1-877-526-7890. On 8/19/16, firm sent a copy of a customer notification letter that will be sent to their customers to inform them that of the communication letter that was released in August 2016 by Medtronic regarding potential for aortic vascular trauma with the use of the Medtronic EnVeo R Delivery Catheter System (DCS). The letter informs the customers that FDA classify the recall as a Class II recall and the recall does not require customers to return the product. The recall letter informs the customers that Medtronic has taken further action by updating all customer training materials and the Instructions for Use (IFU).
Quantity in commerce: 7,319 units
Distribution: Worldwide Distribution -- US, Australia, Austria, Belgium, Brazil, Colombia, Costa Rica, Czech Republic, Denmark, Dominican Republic, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Kazakhstan, Korea, Kuwait, Latvia, Lebanon, Lithuania, Luxembourg, Macedonia, Malaysia, Morocco, Netherlands, New Zealand, Norway, Oman, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, Trinidad and Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
Product codes and lots: all lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2546-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2546-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-24	2016-08-16

Product code NPT

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)