International safety notice
Medical institutions in Japan and overseas have reported that “Contact Force Catheter is intended” when this product is connected to a TactiSys Quartz unit. We have received reports that you are receiving an error message "for single use only". After investigation, we have found that some products The device may be mistakenly recognized as previously used if it is shipped with a previous use date recorded. I understand.
Japan / PMDA Recalls · JPN · Mar 24, 2022
Key facts
| Title | Medical institutions in Japan and overseas have reported that “Contact Force Catheter is intended” when this product is connected to a TactiSys Quartz unit. We have received reports that you are receiving an error message "for single use only". After investigation, we have found that some products The device may be mistakenly recognized as previously used if it is shipped with a previous use date recorded. I understand. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Cardiovascular catheter for ablation Brand name: TactiCath SE Irrigation Catheter |
| Manufacturer | Abbott Medical Japan LLC |
| Models | 8184817, 8202313, 8184393, 8184739, 8162700, 8190306, 8181068, 8203857, 8183581, 8179358, 8203518, 8180723 and 12 more |
| Date | Mar 24, 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