St Jude Medical — Class II medical device recall Z-0108-2015
Terminated recall by St Jude Medical, reported 2014-10-29, distributed nationwide. St. Jude Medical is conducting a voluntary recall of SMJ Batch # 4641580 of the Fast-Cath Trio" Hemostasis Int
| Recall number | Z-0108-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | St Jude Medical, Saint Paul, MN, United States |
| Recall initiated | 2014-10-14 |
| Classified | 2014-10-21 |
| Reported by FDA | 2014-10-29 |
| Terminated | 2015-03-25 |
| Distributed | Nationwide (US) |
| Quantity | 220 |
| Lot numbers | 4641580 |
| Model numbers | 406308 |
Product
St Jude Medical, 10F Fast-Cath Trio" Hemostasis Introducer, REF # 406308, Sterile EO. The Fast-Cath Trio" Hemostasis Introducer consists of the following components: Port hemostasis adapter (3), Sheath (10F Cath-Lock"), dilator (10F) and 0.038 guidewire. See product labeling for diagram of contents.
Reason for recall
St. Jude Medical is conducting a voluntary recall of SMJ Batch # 4641580 of the Fast-Cath Trio" Hemostasis Introducer, Catalog number 406308. The inner diameter of the 10F dilator is too small, such that the guidewire cannot advance through the device which may result in a procedural delay while another dilator of the desired size is obtained.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0108-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.