Recall Z-3257-2011
St Jude Medical · initiated February 10, 2011
Product
7 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 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.
Codes / lots: Model: 83726. Lots: 3167515, 3174474, 3183198, 3276124, K17381, K18242, K28491, K29692, K30008, and K30240.
Reason for recall
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-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-3257-2011
- Initiated
- February 10, 2011
- Posted by FDA
- September 16, 2011
- Terminated
- April 3, 2012
- Product code
- LPB – Cardiac Ablation Percutaneous Catheter
- Quantity
- 179 units total
- Distribution
- Nationwide Distribution including the states of TN, MS, IN, MO, FL, WI, CA, and MT.
- Recalling firm
- St Jude Medical, Saint Paul, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-3255-2011 | 7 F Therapy Ablation Catheter, 4 mm Tip Thermistor, Model (Reorder #) 83724…The recall was initiated because St. Jude Medical has confirmed that the Therapy Ablation Catheter, 4 mm Tip… | 02/10/2011Terminated |
| Z-3256-2011 | 7 F Therapy Ablation Catheter, 4 mm Tip Thermistor, Model (Reorder #) 83725…The recall was initiated because St. Jude Medical has confirmed that the Therapy Ablation Catheter, 4 mm Tip… | 02/10/2011Terminated |