International safety notice
During the pre-shipment inspection of this product, it was confirmed that foreign matter had entered the product, so we investigated the cause and found that the problem occurred when the balloon lumen was formed. It was discovered that a foreign object had gotten into the product's balloon lumen. Based on the above, we have decided to carry out a voluntary recall of products from the relevant lot where the above event may have occurred. did.
Japan / PMDA Recalls · JPN · May 9, 2022
Key facts
| Title | During the pre-shipment inspection of this product, it was confirmed that foreign matter had entered the product, so we investigated the cause and found that the problem occurred when the balloon lumen was formed. It was discovered that a foreign object had gotten into the product's balloon lumen. Based on the above, we have decided to carry out a voluntary recall of products from the relevant lot where the above event may have occurred. did. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: central circulatory system embolus capture catheter Sales name: TMP Occlusion |
| Manufacturer | Tokai Medical Products Co., Ltd. |
| Models | PBG184682, PBG183451, PBG184246, BG99390, BG88590, PBG180832, PBG183942, BG99390F, PBG182767 |
| Date | May 9, 2022 |
| 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