Recall Z-0980-2012
Biosense Webster, Inc. · initiated November 22, 2010
Product
EZ Steer ThermoCool Nav Part Number D-1292-02-S Diagnostic/Ablation Catheter instructions for use. The Biosense EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter is a multi-electrode luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency (RF) current to the catheter tip electrode for ablation purposes. The catheter shaft measures 7.5 F with 8 F ring electrodes. For ablation, the catheter is used in conjunction with an RF generator and a dispersive pad (indifferent electrode) for the treatment of: - Type I atrial flutter in patients age 18 or older. - Recurrent drug/device refractory sustained monomorphic ventricular tachycardia (VT) due to prior myocardial infarction (Mil in adults. - Drug refractory recurrent symptomatic paroxysmal atrial fibrillation, when used with compatible three-dimensional electroanatomic mapping systems. The EZ STEER~ THERMOCOOL~ NAV Diagnostic/Ablation Deflectable Tip Catheter provides location information when used with CARTO~ EP Navigation Systems.
Codes / lots: Lot Numbers: 15214996M, 14070102A, 15177599, 15156690, 15156649, 15123384, 15111287, 15079216, 15076033, 15070702, 14138791, 14117351, 14117345, 14117339, 14113236, 14109201, 14102119, 14102116 14093807, 14091431, 14087720, 14081176, 14077787, 14076743, 14075452, 14071539, 14071538, 14068519, 14066570, 14064255, 14060307, 14058853, 14058117, 14056270, 14056269, 14053165, 14052248, 14052247, 14049472, 14043262, 14040370, 14039651, and 14036714
Reason for recall
Biosense Webster, Inc. has recently become aware of the omission of the following two Warning and Precaution statements on the Instructions For Use (IFU) for the above catheter: 1. If phrenic nerve location is a concern, precautionary measures are recommended to evaluate the proximity of the nerve to the ablation electrode, such as pacing maneuvers. 2. To minimize risk of atrio-esophageal fist
FDA-determined cause: Labeling design
Action taken
Biosense Webster, Inc. sent an Urgent Field Safety Notice letter dated Novembe 22, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were advised to continue use of the affected product and that no further action is required on their part. Consignees were advised that the updated IFU can be found at www.jnjgatewayifu.com. Consignees were instructed to contact their local Biosense Webster representative if they have any questions or require additional information. For questions regarding this recall call 909-839-8604.
Details
- Recall number
- Z-0980-2012
- Initiated
- November 22, 2010
- Posted by FDA
- February 7, 2012
- Terminated
- February 8, 2012
- Product code
- OAE – Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
- Quantity
- 23 units (in total)
- Distribution
- Nationwide Distribution
- Recalling firm
- Biosense Webster, Inc., Irwindale, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0979-2012 | EZ Steer ThermoCool Nav Part Number D-1292-01-S Diagnostic/Ablation Catheter…Biosense Webster, Inc. has recently become aware of the omission of the following two Warning and Precaution… | 11/22/2010Terminated |
| Z-0981-2012 | EZ Steer ThermoCool Nav Part Number D-1292-03-S Diagnostic/Ablation Catheter…Biosense Webster, Inc. has recently become aware of the omission of the following two Warning and Precaution… | 11/22/2010Terminated |
| Z-0982-2012 | EZ Steer ThermoCool Nav Part Number D-1292-04-S Diagnostic/Ablation Catheter…Biosense Webster, Inc. has recently become aware of the omission of the following two Warning and Precaution… | 11/22/2010Terminated |
| Z-0983-2012 | EZ Steer ThermoCool Nav Part Number D-1292-05-S Diagnostic/Ablation Catheter…Biosense Webster, Inc. has recently become aware of the omission of the following two Warning and Precaution… | 11/22/2010Terminated |