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.
Recall
- Recall Number
- Z-2448-2019
- Event Number
- 83535
- Firm
- LeMaitre Vascular, Inc.
- FEI Number
- 1220948
- Product Code
- MJN
- Status
- Terminated
- Root Cause
- Labeling mix-ups
- Initiated
- July 24, 2019
- Terminated
- May 11, 2020
- Address
- 63 2nd Ave, Burlington, MA, 01803-4413
Description
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.
incorrect device size being listed on the impacted device packaging
1. Quarantine any catalog # 2107-80 devices from lot OLC1051. 2. Complete the enclosed customer reply form and return it to LeMaitre Vascular GmbH by scanning it and emailing it to [email protected]. NOTE: The customer reply form must be returned even if you have no devices at your facility. 3. LeMaitre Vascular GmbH will contact you with information on how to return the product and they will send you replacement devices. For further information about this recall, contact Tobias Malcharczik at [email protected].
GERMANY FRANCE SLOVENIA SPAIN SWEDEN UK
62 units