FDAFDA · Food and drugs·Recall number Z-2448-2019
The LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a latex balloon, it is offered in two balloon sizes: 28 mm or 45mm. The single lumen acts as the inflation lumen for the balloon and is indicated by the white stopcock. Other features include a balloon wall thickness designed to reduce the possibility of puncture by calcium deposits, and a stop-cock to maintain balloon inflation level throughout the procedure.
Published September 11, 2019 · Recall initiated: July 24, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
incorrect device size being listed on the impacted device packaging
What to do
Voluntary: Firm initiated · Visit
Recall details
- Manufacturer
- LeMaitre Vascular, Inc.
- Distributor
- GERMANY FRANCE SLOVENIA SPAIN SWEDEN UK
- Lot
- Lot # OLC1051
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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