Bard Caliber — Class II medical device recall Z-0876-2015
Terminated recall by PEROUSE MEDICAL, reported 2015-01-07, distributed nationwide. Additional instructions for use due to inability to raise the pressure above 10 atm during inflation phase may
| Recall number | Z-0876-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | PEROUSE MEDICAL, Ivry Le Temple, N/A, France |
| Recall initiated | 2014-10-06 |
| Classified | 2014-12-29 |
| Reported by FDA | 2015-01-07 |
| Terminated | 2017-03-24 |
| Distributed | Nationwide (US) |
| Quantity | 24,821 units |
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
Reason for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0876-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.