Class II — PEROUSE MEDICAL
| Recalling firm | Perouse Medical |
|---|---|
| Registered facility | Perouse Medical (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Additional instructions for use due to inability to raise the pressure above 10 atm during inflation phase may result in an incomplete inflation or delay in procedure |
| Product | Bard Caliber (CL3030) Inflation Device Product Usage: Inflation Device intended for use during cardiovascular to create and maintain, monitor pressure in the balloon catheter - balloon inflation device for angioplasty procedures |
| Quantity | 24821 units |
| Distribution | US Nationwide Distribution in the states of AZ and CO. |
| Initiated | 2014-10-06 |
| Classified | 2014-12-29 |
| Terminated | 2017-03-24 |
| Recall number | Z-0876-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — PEROUSE MEDICAL (Z-0876-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/69879/
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