International safety notice
``POLARSHEATH Stealable Sheath'' (hereinafter referred to as ``POLARSHEATH Stealable Sheath'', a component of ``POLARx Cryoablation Catheter'') Due to incorrect tools being used during the manufacturing process, the liner in the sheath shaft lumen was It has been confirmed that the protective film may peel off. Due to the possibility of liner peeling (hereinafter referred to as “this event”) due to We have decided to carry out a voluntary recall.
Japan / PMDA Recalls · JPN · Feb 14, 2024
Key facts
| Title | ``POLARSHEATH Stealable Sheath'' (hereinafter referred to as ``POLARSHEATH Stealable Sheath'', a component of ``POLARx Cryoablation Catheter'') Due to incorrect tools being used during the manufacturing process, the liner in the sheath shaft lumen was It has been confirmed that the protective film may peel off. Due to the possibility of liner peeling (hereinafter referred to as “this event”) due to We have decided to carry out a voluntary recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Cardiovascular catheter for ablation Brand name: POLARx cryoablation catheter |
| Manufacturer | Boston Scientific Japan Co., Ltd. |
| Models | M004CRBS3050, 33000339, 33052646, 33052648, 33000334, 33061576, 33052647, 33000338, 33000333, 33052649, 33000337, 33000331 and 1 more |
| Date | Feb 14, 2024 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1