FDA Device recall Z-1160-2026
AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm
- FDA Device
- Class I
- ongoing
- Published 2026-02-11
On 2026-02-11 the FDA classified a Class I recall of AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm by Boston Scientific, citing increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the pro….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1160-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-12-19 |
| Published | 2026-02-11 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Boston Scientific |
| Distribution | US |
Product
AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Material Number (UPN): M00553690;
Reason
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.
Identifiers
| code_info | Material Number (UPN): M00553690; UDI-DI: 191506008093; Lot Numbers: 35960775, 35960777, 35962525, 36100561, 36101748,…Material Number (UPN): M00553690; UDI-DI: 191506008093; Lot Numbers: 35960775, 35960777, 35962525, 36100561, 36101748, 36111316, 36154532, 36154533, 36241501, 36251362, 36253016, 36293839, 36301625, 36303192, 36420219, 36425888, 36449561, 36458830, 36461449, 36478580, 36492661, 36495673, 36573597, 36573598, 36573599, 36574152, 36576474, 36584299, 36604665, 36731807, 36731808, 36737997, 36743059, 36743200, 36904231, 36904232, 36904233, 36906587, 36907000, 36907001, 36907032, 37217612, 37217613, 37217614, 37440330, 37495327, 37511242, 37602825, 37602826, 37689946, 37694053, 37694054, 37764851, 37764852, 37995048, 37995049, 37995050, 38025042, 38025043, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1160-2026%22
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