LeMaitre Single Lumen Embolectomy Catheter 5F — Class II medical device recall Z-0388-2016
Terminated recall by LeMaitre Vascular, Inc., reported 2015-12-16, distributed nationwide. Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromis
| Recall number | Z-0388-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | LeMaitre Vascular, Inc., Burlington, MA, United States |
| Recall initiated | 2015-10-21 |
| Classified | 2015-12-04 |
| Reported by FDA | 2015-12-16 |
| Terminated | 2019-07-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, CH, CO, CR, CZ, DE, DK, EG, ES, FR, GB, IS, IT, JO, JP, LU, LV, MA, NL, NO, OM, PE, PL, PT, SE, SI, TH, VN |
| Quantity | 4,315 total |
| Reason classes | sterility |
| Model numbers | 1601-58, E1601-58 |
Product
LeMaitre Single Lumen Embolectomy Catheter 5F, 80 cm, Model 1601-58 and e1601-58. Indicated for the removal of arterial emboli and thrombi.
Reason for recall
Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.
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-0388-2016. 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.