International safety notice
This product has a component called a "retainer" that fixes the reservoir used in conjunction with the pump's reservoir housing. In this case, the connection between the reservoir and the reservoir compartment became loose due to damage to the retainer, and it could no longer be properly secured to the pump. Information for discontinuing the use of pumps with damaged retainers from November 22, 2019 due to a reported problem. We are providing. We have decided to collect the old (Ryozen) pump and offer a pump with a black retainer (after improvement). It will take several months before we can start providing the new Tena (improved) pump, but if the pump falls or hits a hard object, If the retainer is not loosened, damaged, or missing due to use, continue to use the pump. There is no problem.
Japan / PMDA Recalls · JPN · Oct 7, 2021
Key facts
| Title | This product has a component called a "retainer" that fixes the reservoir used in conjunction with the pump's reservoir housing. In this case, the connection between the reservoir and the reservoir compartment became loose due to damage to the retainer, and it could no longer be properly secured to the pump. Information for discontinuing the use of pumps with damaged retainers from November 22, 2019 due to a reported problem. We are providing. We have decided to collect the old (Ryozen) pump and offer a pump with a black retainer (after improvement). It will take several months before we can start providing the new Tena (improved) pump, but if the pump falls or hits a hard object, If the retainer is not loosened, damaged, or missing due to use, continue to use the pump. There is no problem. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common Name: Portable Insulin Infusion Pump Brand name: Medtronic MiniMed 600 series |
| Manufacturer | Japan Medtronic Co., Ltd. |
| Models | NG1066893H, NG1596297H, NG1842435H, NG1244161H, NG1601908H, NG1955292H, NG1780366H, NG1360198H, NG1100221H, NG1935519H, NG1780802H, NG1306570H and 6012 more |
| Date | Oct 7, 2021 |
| 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