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Covidien Llc Recall 88817

Description: Covidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1

Covidien Llc Recall 88817 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0210-2022
Event ID88817
Event DescriptionCovidien Emprint Ablation Catheter with Thermosphere Technology Bronchoscopic Ablation, CFN CA108L1
Product TypeDevices
DistributionNo domestic distribution. Foreign distribution to Hong Kong and UK.
Quantity14 units
Recall ReasonThe firm identified an error in the device temperature monitoring circuitry which is designed to interrupt energy delivery in the event of a primary cooling system failure. Use of an affected device in conjunction with a primary cooling system failure could lead to the applicator tip overheating and associated heat damage which could result in an allergic/toxic reaction, unintended tissue ablation, tissue burn, and/or a delay of treatment while an alternate device is located.
Device Classification20211117
Device Code InfoLot 516840
Center Classification Date20211105
Recall Initiation Date20210929
Recalling FirmCovidien Llc
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