Agency classClass IIOur severity:Severe FDA (Devices)·Z-0057-2018·Announced 2017-11-08

Biosense Webster Recalls THERMOCOOL Catheters Due to Navigation System Alert

Biosense Webster is recalling 19 THERMOCOOL catheters because they trigger a false magnetic distortion alert on the CARTO 3 System, potentially leading to unintended ablation.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk of significant injury (unintended ablation) due to a device malfunction, which aligns with the 'Severe' criteria for significant injury reports or high-risk device defects.

Plain-English summary

Biosense Webster, Inc. is recalling 19 units of the THERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter (D133602S). The recall affects specific lots identified by codes 17688816M, 17697930M, and 17697966M. These devices were distributed in the United States and numerous international locations, including Japan, Canada, Australia, and various European and South American countries.

The recall was initiated after the manufacturer received an increased number of complaints regarding the display of Alert 402 on the CARTO 3 System when these specific catheters are connected. Alert 402 indicates a "Map: magnetic distortion." This false alert may cause the physician to deliver radiofrequency (RF) energy in an unintended area, posing a risk of injury to the patient.

Healthcare providers and facilities that have received these specific lots of THERMOCOOL catheters should stop using them immediately. They should contact Biosense Webster, Inc. for instructions on how to return the affected units for replacement or refund.

The recalled product

Product: THERMOCOOL SMARTTOUCH Uni-Directional Navigation Catheter (D133602S)
Manufacturer: Biosense Webster, Inc.
Category: Medical Device — Cardiac Catheter
Hazard: unintended-ablation
device-malfunction
Affected units: 19

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

17688816M
17697930M
17697966M

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 5 recalled by Biosense Webster, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Same manufacturer · Biosense Webster, Inc.

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Same hazard · unintended ablation