International safety notice
In cases of highly calcified lesions, MH Surgent Support Catheter (compatible guide wire diameter 0.018 inch) (hereinafter referred to as It has been discovered that there is an incident where the outer coating of ``Recovery Items'') is damaged in the same location. As a result of discussions with the manufacturer regarding this event, we found that it is not possible to prevent recurrence of this event by simply limiting the cases in which users use the product. Since it would be difficult to stop the product, we decided that it would be appropriate for the manufacturer to recall the product.
Japan / PMDA Recalls · JPN · Jul 18, 2024
Key facts
| Title | In cases of highly calcified lesions, MH Surgent Support Catheter (compatible guide wire diameter 0.018 inch) (hereinafter referred to as It has been discovered that there is an incident where the outer coating of ``Recovery Items'') is damaged in the same location. As a result of discussions with the manufacturer regarding this event, we found that it is not possible to prevent recurrence of this event by simply limiting the cases in which users use the product. Since it would be difficult to stop the product, we decided that it would be appropriate for the manufacturer to recall the product. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Catheter for penetrating vascular stenosis Brand name: MH Surgent Support Catheter |
| Manufacturer | Medicos Hirata Co., Ltd. |
| Models | 2310868, 2301764, 2213312, 2305143, 2300983, 2303788, 2300985, 2308172, 2305372, 2305368, 2302972, 2307855 and 102 more |
| Date | Jul 18, 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