TRUE Dilatation Balloon Valvuloplasty Catheter

Model / Serial
02045-11, 02245-12, 02445-12, 02645-13 | PLN00749
Product Description
MD: cardiac valvuloplastic catheter
Manufacturer
Loma Vista Medical, Inc.
1 Event
- Field Safety Notices about TRUE Dilatation Balloon Valvuloplasty Catheter

Manufacturer

Loma Vista Medical, Inc.

Manufacturer Parent Company (2017)
Becton, Dickinson and Company
Source
SATP

One device with a similar name

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Device Recall TRUE Dilatation Balloon Valvuloplasty Catheter

Model / Serial
All lot numbers lower than PLN00749 are subject to this recall.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution-US Distribution in New Jersey and the countries of Germany, Switzerland, Italy, Norway, The Netherlands, Spain, Portugal, Ireland, and Austria.
Product Description
TRUE Dilatation Balloon Valvuloplasty Catheter, || REF Numbers: 02045-11, 02245-12, 02445-12, and 02645-13; Sizes: || 20mm x 4.5cm, 22mm x 4.5cm, 24mm x 4.5cm, and 26mm x 4.5cm; || Intended to be used for balloon aortic valvuloplasty.
Manufacturer
Loma Vista Medical

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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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