Edwards EVOQUE Tricuspid Delivery System Labeling Update for Valve Functionality
Edwards Lifesciences is updating labeling for the Edwards EVOQUE tricuspid delivery system (REF 9850TDS) to provide a warning if valve replacement delivery system functionality becomes compromised.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a labeling-only update (FDA Class II) with no reported injuries or illnesses. The update provides a warning about a potential functionality issue but does not indicate that the device has caused reported harm or failure. This is a precautionary labeling correction, consistent with a Moderate severity rating.
Plain-English summary
Edwards Lifesciences, LLC is issuing a labeling update for the Edwards EVOQUE tricuspid delivery system (REF 9850TDS, Sterile EO, all lots/UDI 0690103D004EVD000V5). The update provides warning information if the functionality of the valve replacement delivery system becomes compromised.
The affected product has been distributed worldwide, including nationwide distribution across the United States (AR, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV) and internationally in Saudi Arabia, Germany, and the United Kingdom.
Healthcare providers who use or stock this device should review the updated labeling for the warning information regarding potential functionality compromise.
The recalled product
- Product
- Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
- Manufacturer
- Edwards Lifesciences, LLC
- Hazard
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/UDI:0690103D004EVD000V5
Distribution
Related recalls
Same manufacturer · Edwards Lifesciences, LLC
See all →- SevereFEM-FLEX II FEMII018AS cannulas may have wire protruding from body
FDA (Devices) · 2025-07-16
- SevereFEM-FLEX II FEMII018A cannulas may have wire protruding from body
FDA (Devices) · 2025-07-16
- SevereFEM-FLEX II femoral arterial cannulas may have wire protruding from body
FDA (Devices) · 2025-07-16
- SevereFEM-FLEX II FEMII016A cannulas may have wire protruding from body
FDA (Devices) · 2025-07-16
- SevereOptisite OPTI18 arterial cannulas may have wire protruding from the body
FDA (Devices) · 2025-07-16
Same hazard · device malfunction
See all →- SevereJenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation
FDA (Devices) · 2026-10-21
- ModerateMedline recalls CONMED AirSeal Access Port kits due to pressure alert issues
FDA (Devices) · 2026-10-21
- ModerateMedline Recalls Convenience Kits Containing CONMED AirSeal Access Ports
FDA (Devices) · 2026-10-21
- ModerateMedline recalls CONMED AirSeal Access Port kits due to overpressure alerts
FDA (Devices) · 2026-10-21
- SevereJenaValve Trilogy Delivery Catheter Recalled for Sleeve Liner Separation
FDA (Devices) · 2026-10-21
Similar recalls
- SevereEdwards Certitude Delivery System Recalled for Molding Overflow Defect
FDA (Devices) · 2018-01-17
- ModerateEdwards SAPIEN 3 Transcatheter Heart Valve Recalled for Incorrect Size Labeling
FDA (Devices) · 2018-07-25
- HighEdwards Commander Delivery System Recalled for Balloon Component Separation
FDA (Devices) · 2019-02-20
- SevereEdwards SAPIEN 3 Ultra Heart Valve System Recalled for Burst Balloons
FDA (Devices) · 2019-08-28
- SevereBoston Scientific Recalls Lotus Edge Valve Systems Due to Deployment Failure Risk
FDA (Devices) · 2021-01-20
- ModerateEdwards TruWave Pressure Monitoring Set Tubing Detachment Recall
FDA (Devices) · 2021-07-07