Penumbra Inc.
3 recall(s) on record — most severe on record: Class I.
Activity by year
- Recalls (3)
Devices registered here (1)
- Catheter, PercutaneousProduct code DQY (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.1250
Recalls & enforcement
- Class IIOngoing2026-06-03Due to manufacturing issues, reperfusion catheters may fractures
- Class ITerminated2020-12-15The catheter may become susceptible to distal tip damage during use. Distal tip damage in conjunction with pressurization of contrast injection may result in potential vessel damage, and subsequent patient injury or death.
- Class ITerminated2017-06-09Penumbra has identified an issue in these four lots involving a raw material component of the delivery wire. This issue could result in breakage of the delivery wire, which could potentially lead to serious patient injury or death.
Related
- All facilities operated by PENUMBRA, INC.
- Penumbra Inc. (CA)
- Penumbra Inc. (UT)
- PENUMBRA, INC. (CA)
- Penumbra Costa Rica, S.R.L. (CR)
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Penumbra Inc. (FEI 3016591327) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3016591327-penumbra-inc/
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