International safety notice
At an overseas manufacturer, when using a specific lot of this product, the endoscope marker on the tip of the delivery system outer cylinder or the inner cylinder As we have received a report that the distal part of the product has been severed (hereinafter referred to as this event), we have decided to voluntarily recall the lot concerned. Ta.
Japan / PMDA Recalls · JPN · Dec 20, 2024
Key facts
| Title | At an overseas manufacturer, when using a specific lot of this product, the endoscope marker on the tip of the delivery system outer cylinder or the inner cylinder As we have received a report that the distal part of the product has been severed (hereinafter referred to as this event), we have decided to voluntarily recall the lot concerned. Ta. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Pancreatic fistula formation prosthesis Sales name: Hot AXIOS system |
| Manufacturer | Boston Scientific Japan Co., Ltd. |
| Models | M00553640, 34006713, 33315970, 33333648, 33765268, 33686170, 33568703, 33008427, 33577905, 33013790, 33233460, 33509930 and 24 more |
| Date | Dec 20, 2024 |
| 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