Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (29mm) 9630TF29 UDI:00690103201260
Reported: August 28, 2019 Initiated: July 9, 2019 #Z-2227-2019
Product Description
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (29mm) 9630TF29 UDI:00690103201260
Reason for Recall
The 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
Details
- Recalling Firm
- Edwards Lifesciences, LLC
- Units Affected
- 1754
- Distribution
- US: VA, CA, GA, MA, MD, NY, OR, WA, MN, TN, AL, KS OUS: United Kingdom, Switzerland, Sweden, Spain, Portugal, Poland, Norway, Netherlands, Italy, Ireland, Germany, Finland, Denmark, Canary Islands, Canada, Austria
- Location
- Irvine, CA
Frequently Asked Questions
What product was recalled? ▼
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (29mm) 9630TF29 UDI:00690103201260. Recalled by Edwards Lifesciences, LLC. Units affected: 1754.
Why was this product recalled? ▼
The 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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 28, 2019. Severity: Critical. Recall number: Z-2227-2019.
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