Z-2632-2011

1500T14 Cardiac Ablation System - Remote Control The 1500Tl4 Remote Control can control and operate the...

Name: Z-2632-2011 1500T14 Cardiac Ablation System - Remote Control The 1500Tl4 Remote Control can control and operate the...
Creator: St Jude Medical
Published: 2011-05-09
License: https://open.fda.gov/license/

Abbott Medical / initiated 2011-05-09 / Terminated

FDA source

St Jude Medical began a recall of 1500T14 Cardiac Ablation System - Remote Control The 1500Tl4 Remote Control can control and operate the 1500Tl4 RF generator remotely via a connecting cable... on 2011-05-09. The reason FDA records is "The recall was initiated because St. Jude Medical has confirmed its T14 and T12 RF Generator may malfunction upon encountering an unexpected electric current (e.g. static electricity). The resulting 'malfunction results...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2632-2011
Status: Terminated
Initiated: 2011-05-09
Posted: 2011-06-23
Terminated: 2012-04-03
Recalling firm: Abbott Medical
Product: 1500T14 Cardiac Ablation System - Remote Control The 1500Tl4 Remote Control can control and operate the 1500Tl4 RF generator remotely via a connecting cable. It has a duplicate front panel controls and displays as of the generator's front panel, with the addition of an optical encoder knob which is used to select and changes the parameters.
Reason for recall: The recall was initiated because St. Jude Medical has confirmed its T14 and T12 RF Generator may malfunction upon encountering an unexpected electric current (e.g. static electricity). The resulting 'malfunction results in a failure of the generator to respond to key presses properly, and may cause unexpected energy delivery or inability to discontinue energy delivery with the start/ stop butt
FDA root cause: Other
Action: The firm, St. Jude Medical (SJM), sent a "Product Correction" letter dated May 9, 2011 to it's affected customers. The letter described the product, problem and actions to be taken. The customers were instructed to discontinue use of the T14/T12 generators and remote controls until the units have been properly serviced; complete and return the attached field action form, and utilize the units in accordance with the Operators Manual. In case of system malfunction, the customers were instructed to shut off the RF power delivery by turning off the generator via the rocker switch, dislodging the power cord, or disconnecting of the patient cable or indifferent electrode connection. An SJM sales representative will contact the customers in the near future to facilitate repair or exchange of the impacted unit. If you have questions regarding this notice, contact the Marketing Manager, AF at (905-286-4015), Marketing Director, AF/CRM, at (905-286-4107); Product Manager (Tokyo) 03-6255-5740, and/or your SJM sales representative.
Quantity in commerce: 4
Distribution: International distribution only: Canada and Japan.
Product codes and lots: Serial Number: 13615332, 13615330, 13615328, 13615331

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)