Z-3257-2011

7 F Therapy Ablation Catheter, 4 mm Tip Thermistor, Model (Reorder #) 83726, Description: 1304-7-25-XL-TH. St...

Name: Z-3257-2011 7 F Therapy Ablation Catheter, 4 mm Tip Thermistor, Model (Reorder #) 83726, Description: 1304-7-25-XL-TH. St...
Creator: St Jude Medical
Published: 2011-02-10
License: https://open.fda.gov/license/

Abbott Medical / initiated 2011-02-10 / Terminated / root cause: manufacturing process

FDA source

St Jude Medical began a recall of 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... on 2011-02-10. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3257-2011
Status: Terminated
Initiated: 2011-02-10
Posted: 2011-09-16
Terminated: 2012-04-03
Recalling firm: Abbott Medical
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.
Product code: LPB Cardiac Ablation Percutaneous Catheter
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 179 units total
Distribution: Nationwide Distribution including the states of TN, MS, IN, MO, FL, WI, CA, and MT.
Product codes and lots: Model: 83726. Lots: 3167515, 3174474, 3183198, 3276124, K17381, K18242, K28491, K29692, K30008, and K30240.

Product code LPB

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)