Device product
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.
Z-2448-2019
Product summary
- Event
- Event 83535
- Status
- Terminated
- Classification
- Class II
- Quantity
- 62 units
- Official record key
device-enforcement:Z-2448-2019
Official wording
Reason: incorrect device size being listed on the impacted device packaging
Code information: Lot # OLC1051
Distribution pattern: GERMANY FRANCE SLOVENIA SPAIN SWEDEN UK
Derived failure modes
-
Unknown
incorrect device size being listed on the impacted device packaging