nGEN Generators (2020-12-24)

Starting date:

December 24, 2020

Posting date:

January 7, 2021

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-74711

Last updated:
2021-01-07

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  Reason
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  Affected products

Affected Products 

nGEN Generators

Reason

Initial field experience during the external evaluation of nGEN Generator when using the QMODE+ with the QDOT Ablation Catheter presented a higher than expected number of "char" complaints. The development of char on the ablation catheter is a known hazard of radiofrequency ablation. At this time, the device is not being sold commercially in Canada. All nGEN Generators in the field are owned by BWI and have been placed for use in clinical studies (qdot_ngen clinical study (bwi_2019_09)).

Affected products