# FDA recall Z-0835-2019

> **Edwards Lifesciences, LLC** · Class II · device recall initiated 2019-01-22.

## Product

Edward Lifesciences, Edwards Commander Delivery System:  Model Number	UDI Number  9600LDS20A (US)	00690103193930  9600LDS20J	00690103194852  9600LDS23A (US)	00690103193947  9600LDS23J	00690103194869  9600LDS26A (US)	00690103193954  9600LDS26J	00690103194876  9600LDS29A (US)	00690103193961  9600LDS29J	00690103194883  9610TF20	00690103192995  9610TF23	00690103190458  9610TF26	00690103190465  9610TF29	00690103193008      Product Usage:  The Edwards SAPIEN 3 THV, Edwards Commander delivery system and accessories are indicated for use in patients with severe, symptomatic, calcific aortic stenosis

## Reason for recall

This action has been initiated to address complaint reports received for crimp balloon and inflation balloon component separation during TAVR procedures.

## Distribution

WorldwideDistribution

## Key facts

- **Recall number:** Z-0835-2019
- **Recalling firm:** Edwards Lifesciences, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-01-22
- **Report date:** 2019-02-20
- **Termination date:** 2019-03-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Draper, UT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0835-2019

## Citation

> AI Analytics. FDA recall Z-0835-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0835-2019. Source: US FDA. Licensed CC0.

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