InterValve Inc: Medical Device Recall in 2014 - (Recall #: Z-1621-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

InterValve V8 Balloon Aortic Valvuloplasty Catheter, model 172212C110, 192412C110, 212612C110, 232812C110. Used in Cardiovascular procedures for Balloon Aortic Valvuloplasty.

Product Classification:

Class II

Date Initiated: March 14, 2014

Date Posted: May 21, 2014

Recall Number: Z-1621-2014

Event ID: 67964

Reason for Recall:

Leak issues were discovered through accelerated age testing.

Status: Terminated

Product Quantity: 2

Code Information:

Lot numbers: 101637, 101640

Distribution Pattern:

Distribution to TN only

Voluntary or Mandated:

Voluntary: Firm initiated