Langston Dual Lumen Catheter 6F Model 5540 — Class I medical device recall Z-1747-2020
Terminated recall by Vascular Solutions, Inc., reported 2020-05-06, distributed nationwide. The inner lumen of the Langston catheter may separate from the hub during pressure injection.
| Recall number | Z-1747-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vascular Solutions, Inc., Maple Grove, MN, United States |
| Recall initiated | 2020-03-16 |
| Classified | 2020-04-27 |
| Reported by FDA | 2020-05-06 |
| Terminated | 2024-06-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CH, CZ, DE, ES, FR, GB, GR, HK, IE, IL, IT, MX, NL, SE, SK, ZA |
| Quantity | 30,877 units |
| UPC / GTIN / UDI-DI | 10841156100513 |
| Lot numbers | 651278, 651457, 651920, 652097, 652176, 652459, 652628, 652777, 653053, 653319, 653443, 653565, 653776, 653863, 654010, 654190, 654340, 654514, 654657, 654889, 654890, 655128, 655287, 655460, 655465, 655738, 655869, 656191, 656533, 656554, 656727, 656801, 657030, 657243, 657517, 657627, 657680, 657866, 658018, 658151 and 24 more |
| Model numbers | 5540 |
Product
Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies
Reason for recall
The inner lumen of the Langston catheter may separate from the hub during pressure injection.
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-1747-2020. 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.