Z-0559-2021Class II

Evolut (TM) R System. With the following model numbers: a. EVOLUTR-23, Labeled as VLV EVOLUTR-23 VT IR 6L...

Name: Z-0559-2021 Evolut (TM) R System. With the following model numbers: a. EVOLUTR-23, Labeled as VLV EVOLUTR-23 VT IR 6L...
Creator: Medtronic Heart Valves Division
Published: 2020-10-23
License: https://open.fda.gov/license/

Medtronic Heart Valves Division / initiated 2020-10-23 / Terminated / root cause: labeling and UDI

FDA source

Medtronic Heart Valves Division began a recall of Evolut (TM) R System. With the following model numbers: a. EVOLUTR-23, Labeled as VLV EVOLUTR-23 VT IR 6L COMM OUS, VLV EVOLUTR-23 TAV EVOLUT R CE 29L MX, VLV... on 2020-10-23. FDA classified it as Class II and gives the reason as "Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID)". 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-0559-2021
Classification: Class II
Status: Terminated
Initiated: 2020-10-23
Posted: 2020-12-10
Terminated: 2022-11-22
Recalling firm: Medtronic Heart Valves Division
Product: Evolut (TM) R System. With the following model numbers: a. EVOLUTR-23, Labeled as VLV EVOLUTR-23 VT IR 6L COMM OUS, VLV EVOLUTR-23 TAV EVOLUT R CE 29L MX, VLV EVOLUTR-23 TAV CE AU 2Y MX, VLV EVOLUTR-23 TAV JPN MX, VLV EVOLUTR-23 GREY 29L COMM OUS, VLV EVOLUTR-23 TAV EVOLUT R CE 7L MX, VLV EVOLUTR-23 TAV EVOLUT R CE 26L MX, VLV EVOLUTR-23 TAV CA 2Y MX, VLV EVOLUTR-23 GREY 6L COMM OUS, VLV EVOLUTR-23-US TAV 23 US COMM MX; b. EVOLUTR-23-C, Labeled as VLV EVOLUTR-23-C TAV EVOLUT R US IDE MEX; c. EVOLUTR-23-US, Labeled as VLV EVOLUTR-23-US GREY COMM US, VLV EVOLUTR-23-US TAV 23 US COMM MX; d. EVOLUTR-26, Labeled as VLV EVOLUTR-26 TAV EVOLUT R CE 29L MX VLV EVOLUTR-26 VT IR 6L COMM OUS, VLV EVOLUTR-26 TAV EVOLUT R CE 7L MX, LV EVOLUTR-26 TAV CE AU 2Y MX, VLV EVOLUTR-26 TAV JPN MX, VLV EVOLUTR-26 GREY 29L COMM OUS, VLV EVOLUTR-26-US TAV 26 US COMM MX, VLV EVOLUTR-26 TAV CLN OUS MX, VLV EVOLUTR-26 TAV CA 2Y MX, VLV EVOLUTR-26 TAV CE CA 2Y MX, VLV EVOLUTR-26 GREY 6L COMM OUS; e. EVOLUTR-26-C, Labeled as VLV EVOLUTR-26-C TAV EVOLUT R US IDE MEX, VLV EVOLUTR-26-C TAV CLN US MX; f. EVOLUTR-26-US, Labeled as VLV EVOLUTR-26 TAV EVOLUT R CE 29L MX, VLV EVOLUTR-26-US GREY COMM US, VLV EVOLUTR-26-US TAV 26 US COMM MX; g. EVOLUTR-29, Labeled as VLV EVOLUTR-29 TAV EVOLUT R CE 29L MX, VLV EVOLUTR-29 GREY 6L COMM OUS, VLV EVOLUTR-29 VT IR 6L COMM OUS, VLV EVOLUTR-29 TAV CE AU 2Y MX, VLV EVOLUTR-29 TAV JPN MX, VLV EVOLUTR-29 GREY 29L COMM OUS, VLV EVOLUTR-29 TAV EVOLUT R CE 7L MX, VLV EVOLUTR-29 TAV CLN OUS MX, VLV EVOLUTR-29 TAV CA 2Y MX, VLV EVOLUTR-29 TAV CE CA 2Y MX, VLV EVOLUTR-29-US TAV 29 US COMM MX; h. EVOLUTR-29-C, Labeled as VLV EVOLUTR-29-C TAV EVOLUT R US IDE MEX, LV EVOLUTR-29-C TAV CLN US MX, VLV EVOLUTR-29-US TAV 29 US COMM MX; i. EVOLUTR-29-US, Labeled as VLV EVOLUTR-29-US GREY COMM US, VLV EVOLUTR-29-US TAV 29 US COMM MX, VLV EVOLUTR-29 TAV EVOLUT R CE 29L MX; j. EVOLUTR-34, Labeled as VLV EVOLUTR-34 BLUE 29L COMM OUS, VLV EVOLUTR-34 VT IR 6L COMM OUS, VLV EVOLUTR-34 BLUE 6L COMM OUS, VLV EVOLUTR-34 TAV CE AU 2Y MX, VLV EVOLUTR-34 TAV JPN MX, VLV EVOLUTR-34 TAV CLN OUS MX, VLV EVOLUTR-34 TAV CA 2Y MX, VLV EVOLUTR-34 TAV CE CA 2Y MX, VLV EVOLUTR-34 TAV EVOLUT R CE 29L 1Y MX, VLV EVOLUTR-34 TAV EVO R CE 29L 2Y MX SA, DRAPE 9732722 TUBE STERILE O-ARM 20PK; k. EVOLUTR-34-C, Labeled as VLV EVOLUTR-34-C TAV EVOLUT R US IDE MX, VLV EVOLUTR-34-C TAV CLN US MX; l. EVOLUTR-34-US, Labeled as VLV EVOLUTR-34-US BLUE COMM US, VLV EVOLUTR-34-US TAV 34 US COMM MX, VLV EVOLUTR-34 TAV EVOLUT R CE 29L 1Y MX, VLV EVOLUTR-34-US TAV 34 US COMM MX SA.
Product code: NPT Aortic Valve, Prosthesis, Percutaneously Delivered
Reason for recall: Potential for Transcatheter Aortic Valve (TAV) leaflet damage when performing a post-implant balloon dilatation (PID).
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: On 10/23/2020, the firm sent an "Urgent Medical Device Correction" Notification Letter to customers via UPS 2-day delivery informing them that the Recalling Firm has received complaint of valve leaflet damage occurring following a post-implant balloon dilatation (PID) resulting in moderate or severe aortic insufficiency which were detected acutely or during follow up. The Recalling Firm has identified the potential cause of the damage which is due to over-expansion of the narrowest portion (waist) of the Transcatheter Aortic Valves (TAVs). The Recalling Firm is also stating that depending on the choice of balloon, the physicians must consider two factors that may lead to over-expansion of the waist of the TAV: 1.The pressure the balloon is inflated to when performing PID 2.Balloon size used for PID The Recalling Firm is providing detailed guidance on considering the above two facts and is providing in an Appendix (Appendix A) with the Customer Notification Letter. In addition, the Appendix A is providing updated precautionary instructions related to PID. The Recalling Firm is also informing its customers that for patients who have been, or will be, treated with the affected product, should continue to be managed according to their standard patient management protocols. Physicians are also asked to: - Review the updated instructions provided in Appendix A. - Share this information with other physicians in your facility who use the affected product. - After review of this information, complete the enclosed Physician Confirmation Certificate and email to [email protected]. Any Questions can be directed to the Recalling Firm's Field Representatives or Lifeline Technical Services at 1-877-526-7890, Monday-Friday, 8am-5pm Central Time.
Quantity in commerce: 172,851 units
Distribution: Worldwide distribution - U.S. Nationwide distribution and the countries of Panama, Denmark, Austria, Germany, Finland, Sweden, Colombia, India, Mexico, Brazil, Spain, United Kingdom, Australia, Ireland, Italy, Argentina, Japan, Poland, Russian Federation, Hungary, Kazakhstan, Luxembourg, Portugal, Norway, Egypt, Saudi Arabia.
Product codes and lots: All GTINs and associated serial numbers (refer to Attachment A-Product List as of 22-Oct-2020).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0559-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0559-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-16	2020-12-10
Z-0560-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-16	2020-12-10
Z-0561-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-16	2020-12-10

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)