FDA Device recall Z-0019-2024
Guider Softip Guide Catheter 8F PRE-SHAPED 40 100CM, Catalog number M003101440, cardiac guide catheter
- FDA Device
- Class II
- ongoing
- Published 2023-10-11
On 2023-10-11 the FDA classified a Class II recall of Guider Softip Guide Catheter 8F PRE-SHAPED 40 100CM, Catalog number M003101440, cardiac guide catheter by Boston Scientific, citing stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0019-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-07-27 |
| Published | 2023-10-11 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Boston Scientific |
| Distribution | US |
Product
Guider Softip Guide Catheter 8F PRE-SHAPED 40 100CM, Catalog number M003101440, cardiac guide catheter
Reason
Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.
Identifiers
| code_info | GTIN 08714729244318, Lot/Batch Numbers: 25823581, 26059696, 26130255, 26277192, 26746112, 26984240, 27241920, 25823580…GTIN 08714729244318, Lot/Batch Numbers: 25823581, 26059696, 26130255, 26277192, 26746112, 26984240, 27241920, 25823580, 25964485, 25964486, 25964487, 26059694, 26130254, 26277190, 26277191, 26599708, 26599709, 26599710, 26599711, 26599712, 26746113, 26984241, 26984253, 27203538, 27203539, 27379022, 28384669, 28632346, 28632344 |
|---|
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-0019-2024%22
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