Edward Lifesciences — Class II medical device recall Z-0835-2019
Terminated recall by Edwards Lifesciences, LLC, reported 2019-02-20. This action has been initiated to address complaint reports received for crimp balloon and inflation balloon c
| Recall number | Z-0835-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edwards Lifesciences, LLC, Draper, UT, United States |
| Recall initiated | 2019-01-22 |
| Classified | 2019-02-14 |
| Reported by FDA | 2019-02-20 |
| Terminated | 2019-03-26 |
| Quantity | 159,448 units |
| UPC / GTIN / UDI-DI | 00690103190458, 00690103190465, 00690103192995, 00690103193008, 00690103193930, 00690103193947, 00690103193954, 00690103193961, 00690103194852, 00690103194869, 00690103194876, 00690103194883 |
| Model numbers | 00690103190458, 00690103190465, 00690103192995, 00690103193008, 00690103193930, 00690103193947, 00690103193954, 00690103193961, 00690103194852, 00690103194869, 00690103194876, 00690103194883, 9600LDS20A, 9600LDS20J, 9600LDS23A, 9600LDS23J, 9600LDS26A, 9600LDS26J, 9600LDS29A, 9600LDS29J, 9610TF20, 9610TF23, 9610TF26, 9610TF29 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0835-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.