Severity
Critical
CriticalClass IOngoing
FDA Devices recall · Reported April 8, 2020
LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88. The LeMaitre Over the Wire Embolectomy Catheter is indicated for use in the removal of emboli and thrombi during embolectomy and/or thrombectomy. It can also be used for catheter placement over a guidewire, vessel occlusion, fluid infusion and/or aspiration.
There has been an increased trend in reports of catheters failing to deflate during use, which may ultimately lead to tip separation.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
LeMaitre Vascular, Inc. recalled LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-8… - a critical-severity action.
LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-8… was recalled by LeMaitre Vascular, Inc. in April 8, 2020. Reason: There has been an increased trend in reports of catheters failing to deflate during use, which may ultimately…. Check the official notice for the remedy. Verify recall #Z-1567-2020 with the FDA Devices before acting.
The recall
LeMaitre Vascular, Inc. issued this critical-severity FDA Devices recall-There has been an increased trend in reports of catheters failing to deflate during use, which may ultimately….
- Critical
- severity level
- 43K units
- affected scope
- Class I
- classification
- April 8, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1567-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1567-2020) was formally reported on April 8, 2020, with the manufacturer initiating the action on March 23, 2020. It is classified under Critical severity (Class I), 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 43315.
The documented reason for this recall is: There has been an increased trend in reports of catheters failing to deflate during use, which may ultimately lead to tip separation. Distribution data in the federal record shows the product reached: Worldwide distribution: US (Nationwide distribution) and foreign countries of: Australia, Austria, Belgium, Bulgaria, Colombia, Costa Rica, Czech Republic, Dominican Republic, Egypt, El Salvador, Estonia, Finland, Franc…. 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 high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
43315
Related Recalls
6
3 from same agency
Product description
LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88. The LeMaitre Over the Wire Embolectomy Catheter is indicated for use in the removal of emboli and thrombi during embolectomy and/or thrombectomy. It can also be used for catheter placement over a guidewire, vessel occlusion, fluid infusion and/or aspiration.
Reason for recall
There has been an increased trend in reports of catheters failing to deflate during use, which may ultimately lead to tip separation.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-1567-2020 |
| Date reported | April 8, 2020 |
| Date initiated | March 23, 2020 |
| Recalling firm | LeMaitre Vascular, Inc. |
| Firm location | Burlington, MA |
| Affected scope | 43315 |
| Distribution | Worldwide distribution: US (Nationwide distribution) and foreign countries of: Australia, Austria, Belgium, Bulgaria, Colombia, Costa Rica, Czech Republic, Dominican Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Georgia,… |
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-1567-2020) 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.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. 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? ▼
LeMaitre 5F Plus Over the Wire Embolectomy Catheter, Model Nos. 1651-84, e1651-84, 1651-88, e1651-88. The LeMaitre Over the Wire Embolectomy Catheter is indicated for use in the removal of emboli and thrombi during embolectomy and/or thrombectomy. It can also be used for catheter placement over a guidewire, vessel occlusion, fluid infusion and/or aspiration.. Recalled by LeMaitre Vascular, Inc.. Units affected: 43315.
Why was this product recalled? ▼
There has been an increased trend in reports of catheters failing to deflate during use, which may ultimately lead to tip separation.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 8, 2020. Severity: Critical. Recall number: Z-1567-2020.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution: US (Nationwide distribution) and foreign countries of: Australia, Austria, Belgium, Bulgaria, Colombia, Costa Rica, Czech Republic, Dominican Republic, Egypt, El Salvador, Estonia, Finland, France, Germany, Georgia, Hungary, Ireland, Israel, Italy, Japan, Korea, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, and Vietnam..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1567-2020) 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 April 8, 2020. 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.