FDA Device recall Z-1143-2015
Starburst MRI Semi-Flex Electrode Device, 25cm/Attached Cable/14Ga/6.4F, Product No. H7877001039091, Catalog No. 700-103909
- FDA Device
- Class II
- terminated
- Published 2015-03-04
On 2015-03-04 the FDA classified a Class II recall of Starburst MRI Semi-Flex Electrode Device, 25cm/Attached Cable/14Ga/6.4F, Product No. H7877001039091, Catalog No. 700-103909 by Angiodynamics, citing printed mark on the trocar intended to indicate a 5cm distance from the distal tip of the needle is actually located 4cm from the distal tip of the needle.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1143-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-12-19 |
| Published | 2015-03-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Angiodynamics |
| Distribution | AR, AZ, FL, MI, MN, MO, NY, TX, VA, WA, WI |
Product
Starburst MRI Semi-Flex Electrode Device, 25cm/Attached Cable/14Ga/6.4F, Product No. H7877001039091, Catalog No. 700-103909; 25cm/14Ga/6.4F, Product No. H7877001026151, Catalog No. 700-102615; and 25cm/14Ga/6.4F, Product No. H7877001026151, Catalog No. 700-102615
Reason
Printed mark on the trocar intended to indicate a 5cm distance from the distal tip of the needle is actually located 4cm from the distal tip of the needle.
Identifiers
| code_info | Lot No. 4773676, 4776428 and 4780110 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1143-2015%22
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