medical Class I Updated 2019-08-28

Edwards Lifesciences, LLC recalls Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAP

Recalled Product

Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (23mm) 9630TF23 UDI:00690103201246

Hazard / Issue

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

Issued by

FDA

Affected States: VA, CA, GA, MA, MD, NY, OR, WA, MN, TN, AL, KS
Lot/Code Info: All Lots
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →

Related medical Recalls

Boston Scientific Corporation recalls Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Cathete

2022-08-31 · The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for the Guider/40XF/8FR/90CM guide catheter.

Mckesson Medical-Surgical Inc. Corporate Office recalls MEDLINE INDUSTRIES Medline Plug, Catheter Medline Plastic, w

2022-08-31 · Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

GE Healthcare, LLC recalls (1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (

2022-08-31 · Inaccurate Distance and Area measurements with use of Global Stack viewport.

Mckesson Medical-Surgical Inc. Corporate Office recalls B. BRAUN MEDICAL INC. Anesthesia Support Tray SUPPORT TRAY,

2022-08-31 · Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.