Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported September 6, 2023
The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be used as grafts in the in situ or non-reversed bypass procedure. The Chevalier Valvulotome consists of a 70 cm stainless steel shaft with two tips: 1) the cutting tip is shaped like an inverted tulip with four teeth at its base. This tip is designed to cut the vein valve cusps. 2) the other tip is atraumatic and used to test the patency and the course of the vein before the valvulotomy. The Chevalier Valv
Burrs (molding flash) on the cutter may tear the harvested vien
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
LeMaitre Vascular, Inc. recalled The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be… - a moderate-severity action.
The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be… was recalled by LeMaitre Vascular, Inc. in September 6, 2023. Reason: Burrs (molding flash) on the cutter may tear the harvested vien. Check the official notice for the remedy. Verify recall #Z-2468-2023 with the FDA Devices before acting.
The recall
LeMaitre Vascular, Inc. issued this moderate-severity FDA Devices recall-Burrs (molding flash) on the cutter may tear the harvested vien.
- Moderate
- severity level
- 225 units
- affected scope
- Class II
- classification
- September 6, 2023
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2468-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2468-2023) was formally reported on September 6, 2023, with the manufacturer initiating the action on July 13, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. LeMaitre Vascular, Inc. is listed as the recalling firm, operating out of Burlington, MA. Federal records list the affected scope as 225 units.
The documented reason for this recall is: Burrs (molding flash) on the cutter may tear the harvested vien Distribution data in the federal record shows the product reached: International distribution to the countries of Belgium, France, Germany, and United Kingdom.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
225 units
Related Recalls
6
3 from same agency
Product description
The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be used as grafts in the in situ or non-reversed bypass procedure. The Chevalier Valvulotome consists of a 70 cm stainless steel shaft with two tips: 1) the cutting tip is shaped like an inverted tulip with four teeth at its base. This tip is designed to cut the vein valve cusps. 2) the other tip is atraumatic and used to test the patency and the course of the vein before the valvulotomy. The Chevalier Valvulotome is available in three tip diameters: 2.5 mm (Catalog # 40025); 3.0 mm (Catalog # 40030); and 3.5 mm (Catalog # 40035)
Reason for recall
Burrs (molding flash) on the cutter may tear the harvested vien
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2468-2023 |
| Date reported | September 6, 2023 |
| Date initiated | July 13, 2023 |
| Recalling firm | LeMaitre Vascular, Inc. |
| Firm location | Burlington, MA |
| Affected scope | 225 units |
| Distribution | International distribution to the countries of Belgium, France, Germany, and United Kingdom. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2468-2023) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
The Chevalier Valvulotome is a device used to disrupt the valves of veins which are to be used as grafts in the in situ or non-reversed bypass procedure. The Chevalier Valvulotome consists of a 70 cm stainless steel shaft with two tips: 1) the cutting tip is shaped like an inverted tulip with four teeth at its base. This tip is designed to cut the vein valve cusps. 2) the other tip is atraumatic and used to test the patency and the course of the vein before the valvulotomy. The Chevalier Valvulotome is available in three tip diameters: 2.5 mm (Catalog # 40025); 3.0 mm (Catalog # 40030); and 3.5 mm (Catalog # 40035). Recalled by LeMaitre Vascular, Inc.. Units affected: 225 units.
Why was this product recalled? ▼
Burrs (molding flash) on the cutter may tear the harvested vien
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 6, 2023. Severity: Moderate. Recall number: Z-2468-2023.
Where was the recalled product distributed? ▼
Distribution: International distribution to the countries of Belgium, France, Germany, and United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2468-2023) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 6, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.