- Recalling firm
- LeMaitre Vascular, Inc.
- Reason for recall
- Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.
- Affected products (lot / model / serial)
- Catalog Number: E1651-88; UDI-DI: 00840663100866; Lot Number: XOT00002181;
- Units affected
- 54
- Distribution pattern
- US Nationwide distribution in the states of CA, FL, GA, KY, LA, NJ, OH, PA, SC.
- Firm location
- Burlington, MA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-0117-2027
- Recall initiated
- August 28, 2026
- FDA classification date
- October 7, 2026
- FDA report date
- October 14, 2026
- FDA event ID
- 99836
- Last updated on HTM Vibe
- October 21, 2026
