Z-2448-2019Class II

The LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a latex balloon, it is offered in two...

Name: Z-2448-2019 The LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a latex balloon, it is offered in two...
Creator: LeMaitre Vascular, Inc.
Published: 2019-07-24
License: https://open.fda.gov/license/

LeMaitre Vascular Inc. / initiated 2019-07-24 / Terminated / root cause: labeling and UDI

FDA source

LeMaitre Vascular, Inc. began a recall of 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... on 2019-07-24. FDA classified it as Class II and gives the reason as "incorrect device size being listed on the impacted device packaging". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2448-2019
Classification: Class II
Status: Terminated
Initiated: 2019-07-24
Posted: 2019-09-03
Terminated: 2020-05-11
Recalling firm: LeMaitre Vascular Inc.
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.
Product code: MJN Catheter, Intravascular Occluding, Temporary
Reason for recall: incorrect device size being listed on the impacted device packaging
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
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].
Quantity in commerce: 62 units
Distribution: GERMANY FRANCE SLOVENIA SPAIN SWEDEN UK
Product codes and lots: Lot # OLC1051

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2448-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2448-2019	Class II	Terminated	Voluntary: Firm initiated	2019-09-11	2019-09-03

Product code MJN

K132022Class IILemaitre 8F Occlusion CatheterLeMaitre Vascular, Inc. / cleared 2013-11-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)