Notice names this product. LeMaitre Vascular’s TufTex¿ Over-the-Wire Embolectomy Catheter is named in FDA Class II recall Z-0117-2027. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing. Identifying details: Catalog Number: E1651-88; UDI-DI: 00840663100866; Lot Number: XOT00002181;. Units affected: 54. Status: Ongoing.
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
TufTex¿ Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.
Company / brand: LeMaitre Vascular recalls
Affected product: TufTex¿ Over-the-Wire Embolectomy Catheter recall status
Official ID Z-0117-2027 · Official record ↗
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Compiled from connected official public-domain government data. Sources last checked October 22, 2026 at 12:00 PM UTC.