International safety notice
Our company and the overseas manufacturer have received reports of cases in which the distal portion of the delivery wire was severed during the placement procedure for this product. did. We are voluntarily recalling the manufacturing lot of this product identified through the original investigation.
Japan / PMDA Recalls · JPN · Jul 19, 2021
Key facts
| Title | Our company and the overseas manufacturer have received reports of cases in which the distal portion of the delivery wire was severed during the placement procedure for this product. did. We are voluntarily recalling the manufacturing lot of this product identified through the original investigation. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | General name: Prosthetic material for promoting embolization in blood vessels of the central circulatory system Sales name: Pipeline Flex flow diverter system |
| Manufacturer | Japan Medtronic Co., Ltd. |
| Models | A819168, A821019, A912449, A834393, A854828, A825692, A869904, A816329, A914212, PED2-500-16, A848260, PED2-325-20 and 274 more |
| Date | Jul 19, 2021 |
| 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