International safety notice
In Japan, only heparin-added dextrose injection has been approved for use as a purge liquid in combination with this product. It has been done. The use of purge liquid containing sodium bicarbonate has been approved by the pharmaceutical regulations. In this product, a glucose solution with sodium bicarbonate added instead of heparin was used as the purge liquid in the United States. If the backflow prevention valve (check valve) of the purge side arm is exposed to sodium bicarbonate for a long period of time, it may deteriorate. We have decided to voluntarily recall the product as it was discovered that there had been an incident where the product leaked.
Japan / PMDA Recalls · JPN · Apr 20, 2023
Key facts
| Title | In Japan, only heparin-added dextrose injection has been approved for use as a purge liquid in combination with this product. It has been done. The use of purge liquid containing sodium bicarbonate has been approved by the pharmaceutical regulations. In this product, a glucose solution with sodium bicarbonate added instead of heparin was used as the purge liquid in the United States. If the backflow prevention valve (check valve) of the purge side arm is exposed to sodium bicarbonate for a long period of time, it may deteriorate. We have decided to voluntarily recall the product as it was discovered that there had been an incident where the product leaked. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Intracardial pump catheter for circulatory support Brand name: IMPELLA 5.5 Pump catheter for auxiliary circulation |
| Manufacturer | Japan Abiomed Co., Ltd. |
| Models | 405471, 387501, 404266, 385179, 405862, 386132, 404698, 406342, 405172, 1000211, 385162, 385674 and 41 more |
| Date | Apr 20, 2023 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 10–99 Matching device models in FDA data
- 1–9 Matching catalog numbers 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