Z-1032-2012

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

Name: Z-1032-2012 The 1500T9 Cardiac Ablation Generator, RO#lBl-89000 is part of the Therapy Cardiac Ablation System, along...
Creator: St Jude Medical Inc
Published: 2012-01-05
License: https://open.fda.gov/license/

Abbott Medical / initiated 2012-01-05 / Terminated / root cause: supplier

FDA source

St Jude Medical Inc began a recall of The 1500T9 Cardiac Ablation Generator, RO#lBl-89000 is part of the Therapy Cardiac Ablation System, along with the Cool Point irrigation Pump, the Therapy 1300... on 2012-01-05. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-1032-2012
Status: Terminated
Initiated: 2012-01-05
Posted: 2012-02-14
Terminated: 2014-09-04
Recalling firm: Abbott Medical
Product: The 1500T9 Cardiac Ablation Generator, RO#lBl-89000 is part of the Therapy Cardiac Ablation System, along with the Cool Point irrigation Pump, the Therapy 1300 Series Steerable Ablation Catheters, the Therapy Cool Path Ablation Catheters and accessories. The generator is a microprocessor-controlled device that produces a continuous unmodulated radiofrequency (RF) output delivered from the generator between its tip electrode and a dispersive pad for the treatment of atrial flutter.
Product code: OAD Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
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.
Root cause tag: supplier
FDA root cause: Vendor change control
Action: 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.
Quantity in commerce: 2 units
Distribution: Nationwide Distribution, including the states of Kansas and Maryland.
Product codes and lots: T9 Generator - Catalog 1500T9/Model IBI-89000. Serial numbers: 13826729 and 13827596.

Product code OAD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)