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EZ Steer ThermoCool Nav Part Number D-1292-05-S… recallZ-0983-2012 · Biosense Webster, Inc. · initiated Nov 22, 2010

Terminated All recalls posted in February 2012

Is my device affected?

  1. 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.
  2. If yours is listed, follow the instructions from Biosense Webster, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. 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

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 root cause category: Labeling design

What the company is doing

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.

Recall details

Recall number
Z-0983-2012
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Nov 22, 2010
Posted by the FDA
Feb 7, 2012
Recalling firm
Biosense Webster, Inc.
Quantity
24,713 units in total
Product code
OAE
FDA submissions
P030031
Distribution
Nationwide Distribution

Product description

EZ Steer ThermoCool Nav Part Number D-1292-05-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.

Code information (models, lots, serial numbers)

Show the full code information (3k characters)

Lot Numbers: 15219359M, 15219356M, 15214930M, 15214908M, 15214902M, 15208638M, 15208634M, 15208631M, 15208628M, 15208626M, 15208619M, 15208612M, 15208607M, 15208593M, 15205050M, 15205047M, 15205031M, 15205018M, 15204883M, 15199820M, 15199819M, 15199811M, 15199801M, 15199794M, 15199792M, 14069263A, 15171668, 15171665, 15171663, 15171652, 15169965, 15169957, 15169946, 15164293, 15164271, 15159938, 15159935, 15159922, 15156563, 15151976, 15148785, 15148772, 15144234, 15144151, 15144134, 15144119, 15136209, 15132418, 15128133, 15128123, 15124171, 15124167, 15123408, 15120034, 15120022, 15116441, 15103256, 15103255, 15098206, 15098200, 15098198, 15098195, 15095224, 15095223, 15095220, 15091259, 15091254, 15083409, 15081335, 15081333, 15076058, 15076049, 15076046, 15071044, 15070717, 15070708, 15067823, 15067817, 15057475, 15040868, 15035767, 15035766, 15032160, 15028721, 15028712, 15028708, 15028701, 15025094, 15021180, 15021179, 15021175, 15021168, 15021164, 15021163, 15021148, 15017983, 15010043, 15010040, 15010033, 15010006, 15009982, 15009980, 15009978, 15009975, 15007267, 15007261, 15007255, 15007254, 14152530, 14149138, 14149136, 14146104, 14146099, 14146095, 14146090, 14146086, 14146084, 14142340, 14142339, 14142335, 14142333, 14142326, 14142325, 14142324, 14142323, 14142322, 14142317, 14142316, 14142314, 14142312, 14142311, 14138878, 14138878, 14138871, 14138866, 14138865, 14138864, 14138860, 14138859, 14120108, 14120105, 14120100, 14120092, 14120078, 14120076, 14120075, 14120067, 14120062, 14120055, 14120015, 14120014, 14120010, 14120006, 14120002, 14120000, 14119986, 14119985, 14119977, 14117438, 14117431, 14117430, 14117429, 14117409, 14117406, 14117404, 14117400, 14117398, 14113274, 14113268, 14113262, 14113257, 14109239, 14109234, 14109231, 14109230, 14109229, 14109228, 14102076, 14099138, 14099135, 14098716, 14098709, 14098706, 14098530, 14098525, 14097835, 14095223, 14090358, 14089643, 14088997, 14088996, 14087736, 14087731, 14085863, 14085143, 14085142, 14085141, 14081912, 14081911, 14081907, 14081809, 14081808, 14081805, 14081804, 14081185, 14080312, 14080310, 14079411, 14078390, 14076755, 14076256, 14076254, 14076253, 14075465, 14075464, 14071644, 14071547, 14068530, 14066590, 14066582, 14065792, 14065065, 14064778, 14064271, 14064266, 14064265, 14063238, 14063236, 14063234, 14062663, 14062660, 14062044, 14061259, 14061256, 14060323, 14060321, 14060320, 14058864, 14058857, 14058125, 14058124, 14058122, 14057221, 14057220, 14053745, 14053740, 14053739, 14053728, 14053724, 14053709, 14053168, 14052551, 14050933, 14049476, 14043896, 14042520, 14039654, 14038050, 14029870, 14029043, 14028071, 14027237, 14025878, 14025127, 14019684, 14016117, and 13435854

Other devices under the same FDA submission

38 devices cleared under P030031 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 60577).

Sources and updates

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