International Medical Devices Database

Manufacturer Address
LeMaitre Vascular, Inc., 3101 37th Ave N, St Petersburg FL 33713-1509
Source
USFDA
1 Event
- Recall of Product is a Pruitt Aortic Occlusion Catheter contained in a molded tray. The product is labeled in part: ''***LeMaitre VASCULAR***Distributed By:LeMaitre Vascular, Inc.***Manufactured By: LeMaitre Vascular, Inc. 3101 37th Avenue North St. Petersburg, FL 33713***Pruitt Aortic Occlusion Catheter***REF 2101-12***STERILE***''.

One device in the database

Product is a Pruitt Aortic Occlusion Catheter contained in a molded tray. The product is labeled...

Model / Serial
Lot No: 1010505-07, 1010505-08, 1030404-09, 104104-05, 1041404-06, 1042204-12, 1042704-01, 1042704-03, 1052204-01, 1061404-04, 1061404-05, 1070204-03, 1080204-08, 1082304-06, l100604-01, l100704-01, l120104-02, l121604-04.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
There are two lots in distribution (175 pieces) that may contain the small hole in the tray. These two lots were distributed in Japan and Europe. There are 16 lots in distribution (1,744 pieces) that utilize the trays with the thin spots that can potentially crack. These 16 lots were distributed in the United States, Canada, Japan and the European Union.
Product Description
Product is a Pruitt Aortic Occlusion Catheter contained in a molded tray. The product is labeled in part: ''***LeMaitre VASCULAR***Distributed By:LeMaitre Vascular, Inc.***Manufactured By: LeMaitre Vascular, Inc. 3101 37th Avenue North St. Petersburg, FL 33713***Pruitt Aortic Occlusion Catheter***REF 2101-12***STERILE***''.

6 manufacturers with a similar name

Learn more about the data here

LeMaitre Vascular, Inc.

Manufacturer Address
LeMaitre Vascular, Inc., 63 2nd Ave, Burlington MA 01803-4413
Manufacturer Parent Company (2017)
LeMaitre Vascular, Inc.
Source
USFDA

Lemaitre Vascular, Inc.

Manufacturer Address
Lemaitre Vascular, Inc., 63 2nd Ave, Burlington MA 01803-4413
Source
USFDA

LeMaitre Vascular, Inc.

Manufacturer Parent Company (2017)
LeMaitre Vascular, Inc.
Source
VNSAWH

LeMaitre Vascular, Inc.

Manufacturer Parent Company (2017)
LeMaitre Vascular, Inc.
Source
SATP

LeMaitre Vascular, Inc.

Manufacturer Parent Company (2017)
LeMaitre Vascular, Inc.
Source
SATP

One more

About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

Stories in your inbox

Do you work in the medical industry? Or have experience with a medical device? Our reporting is not done yet. We want to hear from you.

Tell us your story!

Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

Download the data

The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

Download all (zipped)