Edwards Lifesciences, LLC: Medical Device Recall in 2012 - (Recall #: Z-2191-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7P. For use in patients who require hemodynamic monitoring.

Product Classification:

Class II

Date Initiated: May 11, 2012

Date Posted: August 22, 2012

Recall Number: Z-2191-2012

Event ID: 62278

Reason for Recall:

The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter.

Status: Terminated

Product Quantity: 32,145 units for all products in Recall Event

Code Information:

59169527, 59169528, 59174318, 59174320, 59194314, 59194315, 59194316, 59194317, 59197004, 59197005, 59197006, 59197007, 59197008, 59197009, 59197010, 59197897, 59197898, 59197899, 59197900, 59197901, 59197902, 59197903, 59203374. 59203375, 59203377, 59203378, 59203379, 59203380, 59203381, 59207074, 59207075, 59207076, 59207077, 59216092, 59216093, 59216094, 59216096, 59216097, 59216098, 59216099, 59219846, 59230687, 59230688, 59230689, 59230690, 59230691, 59230692, 59233882, 59238962, 59238963, 59238964, 59238965, 59243250, 59243249, 59247419, 59247421, 59247420, 59247422, 59247423, 59247424, 59247425, 59247426, 59247427, 59247428, 59247429

Distribution Pattern:

Worldwide Distribution-USA (nationwide) and the countries of Canada, Japan, EMEA (Europe, Middle East and Africa), Asia Pacific, (Hong Kong, Indonesia, Malaysia, Australia, and Taiwan, Thailand), Latin America, (Chile, Colombia, Panama, Mexico, and Honduras).

Voluntary or Mandated:

Voluntary: Firm initiated