The 1500T9 Cardiac Ablation Generator, RO#lBl-89000 is part of the Therapy Cardiac Ablation System, along with the Cool

FDA device recall Z-1032-2012 · posted 2012-02-14 · Terminated

Recall details

Recalling firm

St Jude Medical Inc

Reason for recall

Two St Jude Medical 1500T9 RF Generator units were distributed to customers while still under FDA review as part of a PMA supplement to the approved PMA applications.

Action taken

The notification letter was dated January 5th, 2012 and titled "Product Recall RF Generator 1500T9-CP". The letter informed customers that a St Jude Medical 1500T9-CP RF Generator unit had been distributed to them while currently under FDA review as part of a PMA supplement application. The letter requested that the use of the impacted generator be discontinued. Customers were requested to return the field action form and return the unit identified in the letter. The contact number provided in the letter is: 651-756-2000.

Root cause

Vendor change control

Status

Terminated

Product code

OAD

Quantity affected

2 units

Distribution

Nationwide Distribution, including the states of Kansas and Maryland.

Date initiated

2012-01-05

Date posted

2012-02-14

Date terminated

2014-09-04

Location

Saint Paul, MN