International safety notice
An overseas manufacturer sells "Capio Capturing Device (Capio Slim)" (hereinafter referred to as "this product"). The needle/bread of the suture (not included in this product) cannot be captured as expected during use (hereinafter referred to as "this problem"). In response to an increase in complaints regarding We have determined that the tooling may have caused variations in component dimensions that may have affected the functionality of this product. We have decided to voluntarily recall certain lots of this product.
Japan / PMDA Recalls · JPN · Jun 27, 2024
Key facts
| Title | An overseas manufacturer sells "Capio Capturing Device (Capio Slim)" (hereinafter referred to as "this product"). The needle/bread of the suture (not included in this product) cannot be captured as expected during use (hereinafter referred to as "this problem"). In response to an increase in complaints regarding We have determined that the tooling may have caused variations in component dimensions that may have affected the functionality of this product. We have decided to voluntarily recall certain lots of this product. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Single-use automatic suturing device Brand name: Capio Capturing Device |
| Manufacturer | Boston Scientific Japan Co., Ltd. |
| Models | 30434163, 30598976, 30367934, 31727288, 30997334, 31856165, 30842709, 31942747, 30993213, 31942748, M0068318250, 32664886 and 13 more |
| Date | Jun 27, 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