Reported Sep 11, 2019 · Terminated
The LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a latex balloon, it is offered in two balloon…
LeMaitre Vascular, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: LeMaitre Vascular, Inc. · 63 2nd Ave · Burlington, MA · 01803-4413
Is this the product you have?
- The LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a latex balloon
- it is offered in two balloon sizes28 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
- Lot codes and dates
- Lot # OLC1051
- Amount recalled
- 62 units
Why it was recalled
incorrect device size being listed on the impacted device packaging
This product could cause temporary or reversible health problems — stop using it.
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