Thin-Flex Venous Cannula — Class II medical device recall Z-0398-2016
Terminated recall by Edwards Lifesciences, LLC, reported 2015-12-16, distributed nationwide. Edwards Lifesciences initiated a field action for the Thin-Flex Venous Cannula (Model TF292902A) because the c
| Recall number | Z-0398-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Edwards Lifesciences, LLC, Draper, UT, United States |
| Recall initiated | 2015-11-04 |
| Classified | 2015-12-09 |
| Reported by FDA | 2015-12-16 |
| Terminated | 2017-02-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, BE, CZ, ES, FR, GB, IT, KW, NL, RO, SA, SE, SG, TH, ZA |
| Quantity | 8,915 units |
| Lot numbers | 59384061, 59430941, 59456603, 59498228, 59545464, 59580433, 59608030, 59649580, 59677936, 59723695, 59746454, 59779239, 59846864, 59883622, 59931290, 59963196, 59985533, 59999044, 60010418, 60106398, 60113045, 60121142, 60172116, 60181079 |
| Model numbers | TF292902A |
Product
Thin-Flex Venous Cannula, Model Number:TF292902A
Reason for recall
Edwards Lifesciences initiated a field action for the Thin-Flex Venous Cannula (Model TF292902A) because the connector size is incorrectly described in the Edwards product guide as 3/8 inch. The actual and correct connector size is 1/2 inch.
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-0398-2016. 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.