LEMAITRE VASCULAR, INC. FDA Inspection Record
LEMAITRE VASCULAR, INC. is an FDA-registered facility (FEI 1220948) located in BURLINGTON, MA, US. RegDataLab tracks 11 FDA inspections at this facility.
What FDA found at this site
- Latest inspection
- May 16, 2023: Voluntary Action Indicated (VAI)
- Inspections on record
- 11 (3 VAI, 8 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Recalls as the recalling firm
- 17, latest Aug 28, 2026
- Import refusals
- 2
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| May 16, 2023 | Voluntary Action Indicated (VAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) |
| Jun 15, 2022 | Voluntary Action Indicated (VAI) | Contamination control, Lack of or inadequate procedures (21 CFR 820.70(e)) Nonconforming product control (21 CFR 820.90(a)) Equipment suitability & capability (21 CFR 820.72(a)) Documentation (21 CFR 820.100(b)) and 1 more |
| Jul 26, 2021 | No Action Indicated (NAI) | No citations listed |
| Aug 27, 2020 | No Action Indicated (NAI) | No citations listed |
| Aug 1, 2017 | No Action Indicated (NAI) | No citations listed |
| Mar 4, 2013 | Voluntary Action Indicated (VAI) | Training - Lack of or inadequate procedures (21 CFR 820.25(b)) Documentation (21 CFR 820.100(b)) Production and Process Change Procedures, lack of or Inad. (21 CFR 820.70(b)) |
| Oct 31, 2012 | No Action Indicated (NAI) | Quality audits - auditor independence (21 CFR 820.22) Equipment suitability & capability (21 CFR 820.72(a)) Documentation (21 CFR 820.100(b)) Design validation - documentation (21 CFR 820.30(g)) and 1 more |
| Feb 22, 2012 | No Action Indicated (NAI) | No citations listed |
| Feb 22, 2012 | No Action Indicated (NAI) | No citations listed |
| Sep 22, 2010 | No Action Indicated (NAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Aug 28, 2026 | Class II | Z-0117-2027 | TufTex¿ Over-the-Wire Embolectomy Catheter;
Catalog Number: E1651-88; Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing. |
| Apr 11, 2025 | Class II | Z-1750-2025 | TufTex Over-the-Wire Embolectomy Catheter. All Catalog numbers: 1651-34, 1651-38, 1651-44… and 2 more products During internal product testing, it was observed that some packages to have incomplete seals (sterile barrier). |
| Apr 17, 2024 | Class II | Z-1824-2024 | Syntel Silicone Thrombectomy Catheter, Sterile, Rx Only. Used in vascular grafts and… The guide tip can become damaged and result in the tip detaching. |
| Jul 13, 2023 | Class II | Z-2468-2023 | The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be… Burrs (molding flash) on the cutter may tear the harvested vien |
| Sep 30, 2022 | Class II | Z-0228-2023 | TufTex Embolectomy Catheter, Model No.
This catheter has a latex balloon and a single… Three lots tied by two trainees were released without performing the required pull test. If tied with inadequate strength, the proximal… |
| Apr 6, 2021 | Class II | Z-1529-2021 | LeverEdge Contrast Injector: 35 cc syringe with ISO 594 female luer lock - Product Usage… The firm received a complaint regarding particulate found in the packaging foam that could contaminate the sterile field. |
| Mar 23, 2020 | Class I | Z-1567-2020 | LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84… There has been an increased trend in reports of catheters failing to deflate during use, which may ultimately lead to tip separation. |
| Jul 24, 2019 | Class II | Z-2448-2019 | The LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a latex balloon, it… incorrect device size being listed on the impacted device packaging |
| Oct 1, 2018 | Class II | Z-0473-2019 | LeMaitre Vascular Pruitt F3¿-S Polyurethane Outlying Carotid Shunt, Sterile
Model #… Pouches from this lot are not sealed compromising the sterility |
| Jun 19, 2018 | Class II | Z-3042-2018 | AnastoClip GC Closure System, REF# 4007-08 a closure system designed to penetrate the… The wrong instructions for use (IFU) were supplied with the AnastoClip GC closure system. The IFU provided lists some indications which are… |
FDA record score
31 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.
19 records behind this number
| Record | Date | Points x age weight | Adds |
|---|---|---|---|
| Class II recall Z-0117-2027, this FEI as the recalling firm | Aug 28, 2026 | 4 x 1 | 4 |
| Class II recall Z-1750-2025, this FEI as the recalling firm | Apr 11, 2025 | 4 x 1 | 4 |
| Class I recall Z-1567-2020, this FEI as the recalling firm | Mar 23, 2020 | 15 x 0.25 | 3.8 |
| Inspection classified VAI | May 16, 2023 | 6 x 0.6 | 3.6 |
| Inspection classified VAI | Jun 15, 2022 | 6 x 0.6 | 3.6 |
| Class II recall Z-1824-2024, this FEI as the recalling firm | Apr 17, 2024 | 4 x 0.6 | 2.4 |
| Class II recall Z-2468-2023, this FEI as the recalling firm | Jul 13, 2023 | 4 x 0.6 | 2.4 |
| Class II recall Z-0228-2023, this FEI as the recalling firm | Sep 30, 2022 | 4 x 0.6 | 2.4 |
| Class II recall Z-1529-2021, this FEI as the recalling firm | Apr 6, 2021 | 4 x 0.25 | 1 |
| Class II recall Z-2448-2019, this FEI as the recalling firm | Jul 24, 2019 | 4 x 0.25 | 1 |
| Class II recall Z-0473-2019, this FEI as the recalling firm | Oct 1, 2018 | 4 x 0.25 | 1 |
| Class II recall Z-3042-2018, this FEI as the recalling firm | Jun 19, 2018 | 4 x 0.25 | 1 |
| Class II recall Z-1442-2017, this FEI as the recalling firm | Feb 7, 2017 | 4 x 0.25 | 1 |
| Class II recall Z-2543-2016, this FEI as the recalling firm | Aug 3, 2016 | 10 years or older, so it adds no points | 0 |
| Class II recall Z-2283-2016, this FEI as the recalling firm | Jun 22, 2016 | 10 years or older, so it adds no points | 0 |
| Class II recall Z-0378-2016, this FEI as the recalling firm | Oct 21, 2015 | 10 years or older, so it adds no points | 0 |
| Class I recall Z-1754-2013, this FEI as the recalling firm | Jun 17, 2013 | 10 years or older, so it adds no points | 0 |
| Class II recall Z-1054-2013, this FEI as the recalling firm | Mar 18, 2013 | 10 years or older, so it adds no points | 0 |
| Inspection classified VAI | Mar 4, 2013 | 10 years or older, so it adds no points | 0 |
When each source was last refreshed
| Records | Last refreshed | Source as of | Status |
|---|---|---|---|
| Inspections | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Inspection citations | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions (warning letters, injunctions and other action types) | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
| Warning letter text | Nov 14, 2026 | Newest record Nov 10, 2026 | Current |
| Recalls (Enforcement Report) | Nov 14, 2026 | Newest record Nov 11, 2026 | Current |
| Form 483s and inspection documents | Nov 13, 2026 | Newest record Nov 12, 2026 | Current |
| Import refusals | Nov 2, 2026 | Newest record Oct 22, 2026 | Current |
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Facility details
- Company
- LeMaitre Vascular, Inc.
- Location
- BURLINGTON, MA (US)
- Source
- device