FDA Device recall Z-0467-2019
Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain electrophysiological mapping of the c…
- FDA Device
- Class II
- terminated
- Published 2018-11-21
On 2018-11-21 the FDA classified a Class II recall of Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain electrophysiological mapping of the c… by Stryker Sustainability Solutions, citing electrophysiology catheters were identified to be item # D134903 and distributed. It was subsequently determined that these catheters are item # D134909, which is not approved for….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0467-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-08-23 |
| Published | 2018-11-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Stryker Sustainability Solutions |
| Distribution | KS |
Product
Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain electrophysiological mapping of the cardiac structures of the heart.
Reason
Electrophysiology catheters were identified to be item # D134903 and distributed. It was subsequently determined that these catheters are item # D134909, which is not approved for reprocessing.
Identifiers
| code_info | Item Number Serial Number D134903 2519054 D134903 2534027 Note: Item # D134909 is not approved f…Item Number Serial Number D134903 2519054 D134903 2534027 Note: Item # D134909 is not approved for reprocessing by Stryker s Sustainability Solutions Division. Therefore, SSS does not create or possess D134909 labeling. SSS did not receive labeling from the manufacturer. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0467-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.