International safety notice
After receiving reports from medical institutions that the balloon was not fully expanded, an investigation was conducted at an overseas manufacturer. Due to the possibility of a manufacturing defect, we have decided to conduct a voluntary recall of the affected lot products. Did.
Japan / PMDA Recalls · JPN · Jun 24, 2024
Key facts
| Title | After receiving reports from medical institutions that the balloon was not fully expanded, an investigation was conducted at an overseas manufacturer. Due to the possibility of a manufacturing defect, we have decided to conduct a voluntary recall of the affected lot products. Did. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: balloon pumping catheter Brand name: Arrow Ladyguard IABP Catheter Set |
| Manufacturer | Teleflex Medical Japan Co., Ltd. |
| Models | 18F22H0004, 18F23E0036, 18F23D0027, 18F22H0002, 18F23G0025, IAB-06830U, IAB-06840-U, 18F22G0007, 18F22H0010, IAB-06830-U, 18R23G0002, 18F23E0014 and 9 more |
| Date | Jun 24, 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