International safety notice
From July 2020 to August 2021, the built-in malleable wire will be removed from the tip of the catheter of this product worldwide. A total of 14 bug reports have been received. Therefore, we have decided to carry out a voluntary recall of all lots of the affected models whose expiry date remains.
Japan / PMDA Recalls · JPN · Aug 25, 2021
Key facts
| Title | From July 2020 to August 2021, the built-in malleable wire will be removed from the tip of the catheter of this product worldwide. A total of 14 bug reports have been received. Therefore, we have decided to carry out a voluntary recall of all lots of the affected models whose expiry date remains. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: caval cannula Brand name: DLP heart-lung machine cannula (left ventricular vent catheter) |
| Manufacturer | Japan Medtronic Co., Ltd. |
| Models | 12116, 2018090434, 2020021113, 2020060370, 2018111421, 2018080451, 2018080039, 2020011619, 2019041189, 2019060424, 2018111024, 2019070715 and 73 more |
| Date | Aug 25, 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