International safety notice
0.014 In some products of PTA balloon catheter (OTW type), the outer catheter may be damaged due to the manufacturing process. damage to the Due to the possibility of a balloon deflation defect occurring, we have implemented a voluntary recall for a specific lot. I decided to do so.
Japan / PMDA Recalls · JPN · Dec 11, 2024
Key facts
| Title | 0.014 In some products of PTA balloon catheter (OTW type), the outer catheter may be damaged due to the manufacturing process. damage to the Due to the possibility of a balloon deflation defect occurring, we have implemented a voluntary recall for a specific lot. I decided to do so. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Balloon-expandable angioplasty catheter Brand name: 0.014 PTA balloon catheter |
| Manufacturer | Japan Medtronic Co., Ltd. |
| Models | B740725, AB14W050040090 |
| Date | Dec 11, 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