SAPIEN 3 Transcatheter Heart Valve
Edwards Lifesciences
MR Conditional — conditions not yet documented here. We have a Conditional label for this device but the specific scan conditions (field strength, SAR / B1+rms, monitoring requirements) aren't in our records yet. Treat as Not determined and let your MRI team confirm before any scan.
Here's what to do next — you're going to be okay:
- Bring your device card (the wallet card from your surgery) to your appointment. Your MRI team can identify any device from it.
- Call the manufacturer's patient line — the number is on your card. They answer device questions every day.
- Tell your imaging center about your device when you book. They screen every patient before every scan — no one will scan you unless it's safe.
Don't schedule an MRI based on this page alone — your MRI team verifies every device.
What this means for you
MR Conditional — but the conditions are not yet on file. The label exists. The scan rules (field, SAR, monitoring) do not. Treat as Not determined and let your MRI team confirm before any scan.
Here's what to do next — you're going to be okay:
- Bring your device card (the wallet card from your surgery) to your appointment. Your MRI team can identify any device from it.
- Call the manufacturer's patient line — the number is on your card. They answer device questions every day.
- Tell your imaging center about your device when you book. They screen every patient before every scan — no one will scan you unless it's safe.
For information only — your MRI team makes the final decision before any scan. They check every patient, every time.
FDA Recall Alert
Class I — Most SeriousSAPIEN 3 THV was packaged with the incorrect valve size with respect to the label.
💡 What this means for you
This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.
6/10/2018 · View on FDA.gov
FDA Recall Alert
Class I — Most SeriousEdwards Lifesciences is recalling two lot numbers of the 26mm transcatheter heart valve crimper because they may not open sufficiently when the handle is rotated in the full open position. As a result, user may have difficulty fitting a 26mm Sapien transcatheter heart valve into the crimper orifice when preparing the valve for crimping.
💡 What this means for you
This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.
1/19/2014 · View on FDA.gov
FDA Recall Alert
Class I — Most SeriousThe action has been initiated to address reports of burst balloons which have resulted in significant difficulty retrieving the device into the sheath and withdrawing the system from the patient during procedures
💡 What this means for you
This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.
7/8/2019 · View on FDA.gov
FDA Recall Alert
Class II — ModerateSAPIEN 3 THV was packaged with the incorrect valve size with respect to the label.
💡 What this means for you
This is a moderate recall. The device may not perform as intended. Contact your healthcare provider if you have concerns.
6/10/2018 · View on FDA.gov
FDA Recall Alert
Class II — ModerateEdwards Lifesciences is recalling two lot numbers of the 26mm transcatheter heart valve crimper because they may not open sufficiently when the handle is rotated in the full open position. As a result, user may have difficulty fitting a 26mm Sapien transcatheter heart valve into the crimper orifice when preparing the valve for crimping.
💡 What this means for you
This is a moderate recall. The device may not perform as intended. Contact your healthcare provider if you have concerns.
1/19/2014 · View on FDA.gov
FDA Recall Alert
Class II — ModerateHoles in the sterile barrier pouch may be caused by handling of the device during manufacturing or once pouches have been removed from the unit box and stored on the shelf by customers.
💡 What this means for you
This is a moderate recall. The device may not perform as intended. Contact your healthcare provider if you have concerns.
3/25/2013 · View on FDA.gov
FDA Recall Alert
Class I — Most SeriousA component in the Certitude Loader may have a molding overflow defect that could detach during advancement of the delivery system and potentially embolize from the loader into the patient.
💡 What this means for you
This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.
7/20/2017 · View on FDA.gov
FDA Recall Alert
Class I — Most SeriousA component in the Certitude Loader may have a molding overflow defect that could detach during advancement of the delivery system and potentially embolize from the loader into the patient.
💡 What this means for you
This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.
7/20/2017 · View on FDA.gov
FDA Recall Alert
Class I — Most SeriousHoles in the sterile barrier pouch may be caused by handling of the device during manufacturing or once pouches have been removed from the unit box and stored on the shelf by customers.
💡 What this means for you
This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.
3/25/2013 · View on FDA.gov
FDA Recall Alert
Class II — ModerateHoles in the sterile barrier pouch may be caused by handling of the device during manufacturing or once pouches have been removed from the unit box and stored on the shelf by customers.
💡 What this means for you
This is a moderate recall. The device may not perform as intended. Contact your healthcare provider if you have concerns.
3/25/2013 · View on FDA.gov
⚕️ This information is for reference only. A recall does not necessarily mean your device needs removal. Consult your healthcare provider for medical advice.
Category
Heart Valves and Annuloplasty Rings
Body Region
Heart
MRI Conditions
MR Conditional at 1.5T and 3T. Balloon-expandable TAVR valve. Cobalt-chromium frame with bovine pericardial leaflets. Non-ferromagnetic.
Indexed from FDA records. Conditions on this page have not been verified against the manufacturer's instructions for use.