Pulmonary Vein Ablation Catheter Gold (2019-03-03)

Starting date:

March 3, 2019

Posting date:

March 22, 2019

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-69382

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  Reason
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  Affected products

Affected Products

Pulmonary Vein Ablation Catheter Gold

Reason

As per Post Market Surveillance Report (PMSR) for PVAC GOLD/PVAC/MASC/MAAC/T-VAC Multi-Array Ablation Catheters, 10092437DOC Rev 1D: Phrenic Nerve Injury (PNI) exhibited higher occurrence of harm than predicted. PNI is a known possible complication for atrial fibrillation ablation. So, assessment to update the IFU to add warnings and precautions for PNI was made.

Affected products