Device Recall TRUE Dilatation Balloon Valvuloplasty Catheter

All lot numbers lower than PLN00749 are subject to this recall.

Cardiovascular Devices

2

No

Worldwide Distribution-US Distribution in New Jersey and the countries of Germany, Switzerland, Italy, Norway, The Netherlands, Spain, Portugal, Ireland, and Austria.

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.