FDA Device recall Z-1034-2025
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540
- FDA Device
- Class II
- ongoing
- Published 2025-02-05
On 2025-02-05 the FDA classified a Class II recall of HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540 by Boston Scientific, citing reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exc….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1034-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-12-20 |
| Published | 2025-02-05 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Boston Scientific |
| Distribution | US |
Product
HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540
Reason
Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of the procedure to exchange the device for a new one.
Identifiers
| code_info | GTIN: 08714729904564 Lot Numbers: 33169261, 33169263, 33209127, 33243075, 33243077, 33243856, 33255964, 33488328, 33787…GTIN: 08714729904564 Lot Numbers: 33169261, 33169263, 33209127, 33243075, 33243077, 33243856, 33255964, 33488328, 33787031, 33787032, 33853395, 33882221, 33882222, 33899656, 33909280, 33979053, 33979055, 34027245, 34027246, 34035523, 34035524, 34052776, 34052778, 34161831, 34161832, 34161833, 34161834, 34190943, 34190944, 34190945, 34192326, 34192327, 34201917, 34203537, 34203539, 34204795, 34223677, 34223679, 34226399, 34226540, 34243427, 34243428, 34375175, 34381803, 34585408, 34731098 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1034-2025%22
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