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U.S. Department of Health and Human Services

Class 2 Device Recall Lemaitre Aortic Occlusion Catheter

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  Class 2 Device Recall Lemaitre Aortic Occlusion Catheter see related information
Date Initiated by Firm July 24, 2019
Create Date September 03, 2019
Recall Status1 Terminated 3 on May 11, 2020
Recall Number Z-2448-2019
Recall Event ID 83535
510(K)Number K132022  
Product Classification Catheter, intravascular occluding, temporary - Product Code MJN
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.
Code Information Lot # OLC1051
Recalling Firm/
Manufacturer		 LeMaitre Vascular, Inc.
63 2nd Ave
Burlington MA 01803-4413
For Additional Information Contact Laurie Churchill
781-425-1670
Manufacturer Reason
for Recall		 incorrect device size being listed on the impacted device packaging
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 62 units
Distribution GERMANY FRANCE SLOVENIA SPAIN SWEDEN UK
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MJN and Original Applicant = LEMAITRE VASCULAR, INC.
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