International safety notice
Due to poor adhesion between the foot step of the product, which adsorbs to the myocardium, and the suction tube at the end, the tube comes off, resulting in surgery. Multiple cases of malfunctions resulting in poor suction during the procedure were reported. Similar incidents have been observed in several lots of products, so we will recall all currently shipped product lots.
Japan / PMDA Recalls · JPN · Jul 9, 2024
Key facts
| Title | Due to poor adhesion between the foot step of the product, which adsorbs to the myocardium, and the suction tube at the end, the tube comes off, resulting in surgery. Multiple cases of malfunctions resulting in poor suction during the procedure were reported. Similar incidents have been observed in several lots of products, so we will recall all currently shipped product lots. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Single-use organ fixation indenter Brand name: OPHIDIA II Heart Stabilization System |
| Manufacturer | Vital Co., Ltd. |
| Models | S1RB0402V, S1RB0403V, S1RB0201V, S1RB0101V, S1RB0401V, S1RA0901V, S1RA1201V, S1RB0202V |
| Date | Jul 9, 2024 |
| 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