The 1500T9 Cardiac Ablation Generator, RO#lBl-89000 is part… recallZ-1032-2012 · St Jude Medical Inc · initiated Jan 5, 2012
Terminated All recalls posted in February 2012
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from St Jude Medical Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Vendor change control
What the company is doing
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.
Recall details
- Recall number
- Z-1032-2012
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jan 5, 2012
- Posted by the FDA
- Feb 14, 2012
- Recalling firm
- St Jude Medical Inc
- Quantity
- 2 units
- Product code
- OAD
- FDA submissions
- P060019
- Distribution
- Nationwide Distribution, including the states of Kansas and Maryland.
Product description
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.
Code information (models, lots, serial numbers)
T9 Generator - Catalog 1500T9/Model IBI-89000. Serial numbers: 13826729 and 13827596.
Other devices under the same FDA submission
3 devices cleared under P060019 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Cool Point™ IBI-89003Irvine Biomedical, Inc. · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter17 reports
- NA IBI-85786Irvine Biomedical, Inc. · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter1 report
- Cool Point™ H701666Irvine Biomedical, Inc. · Cardiac ablation percutaneous catheter1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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