Devices

AGA AMPLATZER Vascular Plug

Model / Serial
The three lots that were distributed are identified as Lot no. M05F10-11, M05F15-12 and M05F02-47.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
Yes
Distribution
OUS countries include: Australia, Germany, Italy, Korea, Malasia, Slovakia, Spain, Switzerland, Thailand, United Kingdom
Product Description
AMPLATZER Vascular Plug, Manufactured by AGA Medical Corporation , 682 Mendelssohn Avenue, Golden Valley, MN 55427 USA. Sterile EO. Single Use Only. Rx Only. Do not use open or damaged packages. Store in a cool, dry place. The AMPLATZER Vascular Plug is a self-expandable, cylindrical device made from a Nitinol wire mesh. The device is secured on both ends with platinum marker bands. A stainless steel micro screw is welded to one of the platinum marker bands, which allows attachment to the 135 cm long deliver cable. The AMPLATZER Vascular Plugs are made in various sizes ranging from 4 to 16 mm in 2 millimeter increments.
Manufacturer
AGA Medical Corporation
1 Event
- Recall of AGA AMPLATZER Vascular Plug

Manufacturer

AGA Medical Corporation

Manufacturer Address
AGA Medical Corporation, 682 Mendelssohn Ave N, Golden Valley MN 55427-4306
Source
USFDA

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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.

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