International safety notice
In selected lots from the worldwide market, the Luer connection of the 20/30 inflator (which is a component of this product) We have observed an increasing trend in customer complaints regarding leaks from male connectors. As a result, have we confirmed the potential risk of this malfunction due to the O-ring used in the male connector? We will carry out a voluntary recall.
Japan / PMDA Recalls · JPN · Nov 6, 2024
Key facts
| Title | In selected lots from the worldwide market, the Luer connection of the 20/30 inflator (which is a component of this product) We have observed an increasing trend in customer complaints regarding leaks from male connectors. As a result, have we confirmed the potential risk of this malfunction due to the O-ring used in the male connector? We will carry out a voluntary recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Connector for catheters for balloon dilatation angioplasty Sales name: Angioplasty accessory kit (20/30 Indeflator Priority Pack) |
| Manufacturer | Abbott Medical Japan LLC |
| Models | 60538750, 1000186 |
| Date | Nov 6, 2024 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 Matching catalog numbers 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