FDA Medical Device Recalls (openFDA)
St Jude Medical Inc: 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.
- Recall number
- Z-1032-2012
- Recalling firm
- St Jude Medical Inc
- 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.
- Status
- Terminated
- Initiated
- 2012-01-05
- Posted
- 2012-02-14
- Terminated
- 2014-09-04
- Reason
- 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
- 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
- 2 units
- Distribution
- Nationwide Distribution, including the states of Kansas and Maryland.
- Lot, serial or model codes
- T9 Generator - Catalog 1500T9/Model IBI-89000. Serial numbers: 13826729 and 13827596.
- 510(k) numbers
- not on file
- PMA numbers
- ["P060019"]
- Product code
- OAD
- Firm FEI
- 2126673
- Firm city
- Saint Paul
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28