International safety notice
In some lots of RX Hurricane Dilatation Balloons (hereinafter referred to as "this product"), the balloon An increase in reports regarding pinholes (hereinafter referred to as "this event") was observed. We have decided to carry out a voluntary recall of specific lots.
Japan / PMDA Recalls · JPN · Oct 25, 2021
Key facts
| Title | In some lots of RX Hurricane Dilatation Balloons (hereinafter referred to as "this product"), the balloon An increase in reports regarding pinholes (hereinafter referred to as "this event") was observed. We have decided to carry out a voluntary recall of specific lots. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: bile duct dilation catheter Sales name: RX Hurricane Dilation Balloon |
| Manufacturer | Boston Scientific Japan Co., Ltd. |
| Models | 26207984, 26940195, 26123253, 26769421, 26058425, 27269981, 25836098, 26123241, 27308426, 26500637, 26808195, 26559541 and 269 more |
| Date | Oct 25, 2021 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
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