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.
- Company
- Lemaitre Vascular, Inc.
- Recall Initiated
- July 24, 2019
- Terminated
- May 11, 2020
- Recall Number
- Z-2448-2019
- Quantity
- 62 units
- Firm Location
- Burlington, MA
Reason for Recall
incorrect device size being listed on the impacted device packaging
Distribution
GERMANY FRANCE SLOVENIA SPAIN SWEDEN UK
Lot / Code Info
Lot # OLC1051
Root Cause
Labeling mix-ups
Action Taken
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 recalls-emea@lemaitre.com. 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 tmalcharczik@lemaitre.com.
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