Loma Vista Medical: Medical Device Recall in 2013 - (Recall #: Z-1566-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: March 18, 2013

Date Posted: July 3, 2013

Recall Number: Z-1566-2013

Event ID: 65343

Reason for Recall:

Slow deflation time: Slower than normal balloon deflation time of greater than 10 seconds. The balloon normally deflates in less than 5 seconds. The device performance specification for deflation time is 10 seconds maximum.

Status: Terminated

Product Quantity: 2379 units

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated