FDA Device recall Z-1582-2022
Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440
- FDA Device
- Class II
- ongoing
- Published 2022-08-31
On 2022-08-31 the FDA classified a Class II recall of Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440 by Boston Scientific, citing the impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for the Guider/40XF/8FR/90CM guide catheter.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1582-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-08-09 |
| Published | 2022-08-31 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Boston Scientific |
| Distribution | n/a |
Product
Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440
Reason
The impacted products were distributed with an MPXF tip curve shape instead of the 40XF tip curve shape for the Guider/40XF/8FR/90CM guide catheter.
Identifiers
| code_info | UDI/DI 08714729202486, Lot/Batch 27339850, Use By 2021-05-18, and UPDATE: Lot/Batch 29308869, Use By 4/27/2025. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1582-2022%22
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