International safety notice
Changes have been made to certain manufacturing lines for some IN.PACT Admiral drug-coated balloon catheter products. As a result of this, it was discovered that the sterile packaging could be damaged and sterility could no longer be guaranteed. We have decided to carry out a voluntary recall of the product numbered.
Japan / PMDA Recalls · JPN · Mar 24, 2022
Key facts
| Title | Changes have been made to certain manufacturing lines for some IN.PACT Admiral drug-coated balloon catheter products. As a result of this, it was discovered that the sterile packaging could be damaged and sterility could no longer be guaranteed. We have decided to carry out a voluntary recall of the product numbered. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Balloon-expandable angioplasty catheter Brand name: IN.PACT Admiral drug coated balloon catheter |
| Manufacturer | Japan Medtronic Co., Ltd. |
| Models | 0010965798, ADM07006013P, ADM04008013P, 0010935574, ADM05006013P, ADM04015013P, ADM07008013P, 0010896018, 0010926488, 0010975488, 0010863872, 0010861910 and 13 more |
| Date | Mar 24, 2022 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 100–999 Matching device models 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