# FDA recall Z-1567-2020

> **LeMaitre Vascular, Inc.** · Class I · device recall initiated 2020-03-23.

## Product

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.

## 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.

## Key facts

- **Recall number:** Z-1567-2020
- **Recalling firm:** LeMaitre Vascular, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2020-03-23
- **Report date:** 2020-04-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Burlington, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1567-2020

## Citation

> AI Analytics. FDA recall Z-1567-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1567-2020. Source: US FDA. Licensed CC0.

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