FDA Device recall Z-0024-2025
iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616
- FDA Device
- Class II
- ongoing
- Published 2024-10-16
On 2024-10-16 the FDA classified a Class II recall of iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616 by Atrium Medical, citing there is an error in the Unique Device Identifier (UDI) printed on the product's distribution label.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0024-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-09-09 |
| Published | 2024-10-16 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Atrium Medical |
| Distribution | US |
Product
iCast Covered Stent, 6MMx16MMx120CM, Model Number 42616
Reason
There is an error in the Unique Device Identifier (UDI) printed on the product's distribution label.
Identifiers
| code_info | UDI-DI: 00650862426168; Lot Number: 508083; Serial Numbers: 508083031, 508083032, 508083034, 508083035, 508083036, 5080…UDI-DI: 00650862426168; Lot Number: 508083; Serial Numbers: 508083031, 508083032, 508083034, 508083035, 508083036, 508083037, 508083038, 508083039, 508083040, 508083041, 508083042 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Other recalls by Atrium Medical
- Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case
FDA Device · Class II · 2026-09-16 · Atrium Medical - Getinge PVC Thoracic Catheter, Soft PVC Right Angle, 10 per Case
FDA Device · Class II · 2026-09-16 · Atrium Medical - Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case
FDA Device · Class II · 2026-09-16 · Atrium Medical - FLIXENE, 4-7X35, 2GDS, GWT-GW. Double-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical - ADVANTA VXT, 8X40, 1GDS, FH, STR-TW. Single-Ended Slider GDS. Vascular graft
FDA Device · Class II · 2024-06-12 · Atrium Medical
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0024-2025%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.