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LeMaitre Embolectomy Catheter
Lemaitre Vascular, Inc. · Model 1651-78 · UDI-DI 00840663100736
DXE
Prescription
1
510(k) clearances
7,736
Adverse events (143 deaths)
57
Recalls
41
Facilities
Description
7F 80CM Over-the-Wire Embolectomy Catheter
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-21 | PFM MEDICAL INC. | A snare catheter including luer lock, indicated for removal or manipulation of a foreign body in the vascular system, failed to meet the biocompatibility requirements for in-vitro- |
| 2025-04-11 | LeMaitre Vascular, Inc. | During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier). |
| 2024-04-17 | LeMaitre Vascular, Inc. | The guide tip can become damaged and result in the tip detaching. |
| 2023-09-07 | Edwards Lifesciences, LLC | Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds). |
| 2022-10-06 | Edwards Lifesciences, LLC | Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches. |
| 2022-10-06 | Edwards Lifesciences, LLC | Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches. |
| 2022-09-30 | LeMaitre Vascular, Inc. | Three lots tied by two trainees were released without performing the required pull test. If tied with inadequate strength, the proximal ligature could slip toward the tip of the ca |
| 2021-09-20 | Arrow International Inc | 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent |
| 2021-09-20 | Arrow International Inc | 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent |
| 2021-09-20 | Arrow International Inc | 7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.