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.
FDA Recall Z-2448-2019 · Posted None
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Recalling FirmLeMaitre Vascular, Inc.
Recall StatusTerminated
Product CodeMJN
Date Initiated2019-07-24
Date Terminated2020-05-11
Product Quantity62 units
Reason for Recall
incorrect device size being listed on the impacted device packaging
Firm Action
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].
Root Cause
Labeling mix-ups
Distribution Pattern
GERMANY FRANCE SLOVENIA SPAIN SWEDEN UK
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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