7 F Therapy Ablation Catheter recallZ-3256-2011 · St Jude Medical · initiated Feb 10, 2011
Terminated All recalls posted in September 2011
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 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
The recall was initiated because St. Jude Medical has confirmed that the Therapy Ablation Catheter, 4 mm Tip Thermistor Quadripolar, were packaged with the incorrect Instructions for Use (IFU). To ensure accuracy of device labeling, St. Jude Medical is requesting that the incorrect IFU be replaced with the enclose, correct version.
FDA root cause category: Process control
What the company is doing
St. Jude Medical sent an "important Medical Device Safety Information" letter dated February 22, 2011 to all affected customers. The letter includes: affected problem, reconciliation form and corrective action. Customers are asked to remove the incorrect Instructions for Use (IFU) and use the IFU provided in the letter, and to fill out and return the reconciliation form. For questions on this recall please contact the firm at (512) 329-1054 or (651) 756-2869.
Recall details
- Recall number
- Z-3256-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Feb 10, 2011
- Posted by the FDA
- Sep 16, 2011
- Recalling firm
- St Jude Medical
- Quantity
- 179 units total
- Product code
- LPB
- FDA submissions
- P040014
- Distribution
- Nationwide Distribution including the states of TN, MS, IN, MO, FL, WI, CA, and MT.
Product description
7 F Therapy Ablation Catheter, 4 mm Tip Thermistor, Model (Reorder #) 83725, Description: 1304-7-25-L-TH. St Jude Medical Company A sterile, single use catheter with one 4mm ablation electrode at the tip and three 2mm diagnostic electrodes. The catheter includes a temperature sensor in the tip electrode for temperature monitoring and the handle is equipped with a steering mechanism to detect the distal tip of the catheter; both uni-directional and bi-directional versions are available. The catheter is available with various distal curve configurations; the curve is indicated on the catheter label.
Code information (models, lots, serial numbers)
Model: 83725. Lots: 3200476, K21432, K24495, K25197, K28752, K30681, and K30881.
Other devices under the same FDA submission
3 devices cleared under P040014 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Therapy™ IBI-83366Irvine Biomedical, Inc. · Cardiac ablation percutaneous catheter2 reports
- Therapy™ IBI-83365Irvine Biomedical, Inc. · Cardiac ablation percutaneous catheter1 report
- SJM™ IBI-85641Irvine Biomedical, Inc. · Cardiac ablation percutaneous catheter1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 59683).
- Z-3255-2011 · Terminated7 F Therapy Ablation Catheter, 4 mm Tip Thermistor, Model (Reorder #) 83724, Description: 1304-7-25-M-TH. St Jude Medical Company A sterile, single use catheter with one 4mm a…
- Z-3257-2011 · Terminated7 F Therapy Ablation Catheter, 4 mm Tip Thermistor, Model (Reorder #) 83726, Description: 1304-7-25-XL-TH. St Jude Medical Company A sterile, single use catheter with one 4mm a…
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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