Medtronic EnVeo Delivery Catheter System Recalled for Vascular Trauma Risk
Medtronic is recalling 7,319 EnVeo Delivery Catheter Systems worldwide due to a potential for vascular trauma during use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device with a potential for vascular trauma, but the source text does not report any specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Medtronic Cardiovascular Surgery-the Heart Valve Division is recalling 7,319 units of the Medtronic EnVeo R Delivery Catheter System (DCS). The affected models are ENVEOR-L, ENVEOR-L-C, and ENVEOR-US. These devices are designed to replace the native or surgical bioprosthetic aortic heart valve without open heart surgery and without the concomitant surgical removal of the failed valve.
The recall was initiated due to a potential for vascular trauma with the use of the device. The source text does not specify the exact mechanism of the trauma or report any specific injuries or illnesses.
The affected units were distributed worldwide, including in the United States, 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. All lots are affected.
The recalled product
- 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.
- Category
- Medical Device — Cardiovascular
- Hazard
- Affected units
- 7,319
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- all lots
Distribution
Distributed in 1 state:
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