International safety notice
Zeltiq Aesthetics, Inc continues to collect information on adverse events of paradoxical hyperplasia regarding CoolSculpting. I am. The incidence of paradoxical hyperplasia in Cool Core, Cool Curve, Cool Curve+, Cool Max, Cool Fit) is As it was confirmed that the incidence rate was higher than the incidence rate stated in the package insert, the drug has been voluntarily recalled from the global market. We have decided to implement it. Therefore, we have decided to carry out the same collection.
Japan / PMDA Recalls · JPN · Jun 20, 2022
Key facts
| Title | Zeltiq Aesthetics, Inc continues to collect information on adverse events of paradoxical hyperplasia regarding CoolSculpting. I am. The incidence of paradoxical hyperplasia in Cool Core, Cool Curve, Cool Curve+, Cool Max, Cool Fit) is As it was confirmed that the incidence rate was higher than the incidence rate stated in the package insert, the drug has been voluntarily recalled from the global market. We have decided to implement it. Therefore, we have decided to carry out the same collection. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: cooling pack Brand name: Cool Sculpting Suction type applicator (Type name: Cool Core, Cool Curve, Cool Curve+, Cool Max、Cool Fit） |
| Manufacturer | JIMEC Co., Ltd. |
| Models | V0662013108007, V0632010322002, V0642013294004, V0662013214002, V0622012101003, V0662013108004, V0642012240004, V0642014077001, V0622012160005, V0662013134008, V0632014182006, V0662015230004 and 253 more |
| Date | Jun 20, 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