International safety notice
In some lots of the Trapper Exchange Device (hereinafter referred to as the "Product"), there was a problem with balloon expansion (hereinafter referred to as "Product"). An increase in the number of reports regarding this event (hereinafter referred to as "this event") was observed. This occurred due to insufficient adhesive strength between the manifold and telescope handle in a particular lot. I thought it was a possibility. We have decided to do so.
Japan / PMDA Recalls · JPN · Jun 8, 2021
Key facts
| Title | In some lots of the Trapper Exchange Device (hereinafter referred to as the "Product"), there was a problem with balloon expansion (hereinafter referred to as "Product"). An increase in the number of reports regarding this event (hereinafter referred to as "this event") was observed. This occurred due to insufficient adhesive strength between the manifold and telescope handle in a particular lot. I thought it was a possibility. We have decided to do so. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Coronary catheter exchange catheter Sales name: Trapper Exchange Device |
| Manufacturer | Boston Scientific Japan Co., Ltd. |
| Models | H74939330130, 3571027335, 3571027334 |
| Date | Jun 8, 2021 |
| 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