Z-0835-2019Class II

Edward Lifesciences, Edwards Commander Delivery System: Model Number UDI Number 9600LDS20A (US)...

Name: Z-0835-2019 Edward Lifesciences, Edwards Commander Delivery System: Model Number UDI Number 9600LDS20A (US)...
Creator: Edwards Lifesciences, LLC
Published: 2019-01-22
License: https://open.fda.gov/license/

Edwards Lifesciences LLC / initiated 2019-01-22 / Terminated / root cause: labeling and UDI

FDA source

Edwards Lifesciences, LLC began a recall of Edward Lifesciences, Edwards Commander Delivery System: Model Number UDI Number 9600LDS20A (US) 00690103193930 9600LDS20J 00690103194852 9600LDS23A (US)... on 2019-01-22. FDA classified it as Class II and gives the reason as "This action has been initiated to address complaint reports received for crimp balloon and inflation balloon component separation during TAVR procedures". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0835-2019
Classification: Class II
Status: Terminated
Initiated: 2019-01-22
Posted: 2019-02-14
Terminated: 2019-03-26
Recalling firm: Edwards Lifesciences LLC
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
Product code: NPT Aortic Valve, Prosthesis, Percutaneously Delivered
Reason for recall: This action has been initiated to address complaint reports received for crimp balloon and inflation balloon component separation during TAVR procedures.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: The firm began disseminating the notices by letter on 01/22/2019. The notices explained the issue and advised the consignee to follow the guidelines and instructions provided in the Edward SAPIEN3 Commander delivery system training material for device preparation and use. Updated instructions for use will be disseminated in the near future.
Quantity in commerce: 159,448 units
Distribution: WorldwideDistribution
Product codes and lots: (ALL LOTS 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0835-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0835-2019	Class II	Terminated	Voluntary: Firm initiated	2019-02-20	2019-02-14

Product code NPT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)