International safety notice
The following events have been confirmed in specific lots from markets around the world. We will carry out a voluntary recall. a) Contrast leakage from the stopcock connection of the 20/30 indeflator was reported in a specific lot. As a result of an investigation by an outside manufacturer, it was determined that the cause was due to poor molding of the stopcock fitting parts. b) An abnormal connection of the three-way stopcock was reported in a specific lot. It was discovered that due to changing the design of the three-way stopcock, there was a possibility that a sufficient connection could not be obtained.
Japan / PMDA Recalls · JPN · Mar 14, 2022
Key facts
| Title | The following events have been confirmed in specific lots from markets around the world. We will carry out a voluntary recall. a) Contrast leakage from the stopcock connection of the 20/30 indeflator was reported in a specific lot. As a result of an investigation by an outside manufacturer, it was determined that the cause was due to poor molding of the stopcock fitting parts. b) An abnormal connection of the three-way stopcock was reported in a specific lot. It was discovered that due to changing the design of the three-way stopcock, there was a possibility that a sufficient connection could not be obtained. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common names: (1) Angioplasty balloon pressurizer, (2) Angioplasty balloon pressurizer, (3) Balloon-expandable angioplasty connector for catheter Sales name: (1) Indeflator PLUS 30 (2)20/30 Indeflator (3) Angioplasty accessory kit |
| Manufacturer | Abbott Medical Japan LLC |
| Models | 60312167, 60315919, 60317542, 60311338, 60320075, 60312169, 1000184, 1000186, 60309682, 60308575, 60320909, 60320070 and 21 more |
| Date | Mar 14, 2022 |
| 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