RegWardenFDA facility compliance records
Company

PENUMBRA, INC.

3 recall(s) on record — most severe on record: Class I.

Recalls by year

FDA actions on record by year2017: 1 recalls; 2020: 1 recalls; 2026: 1 recalls1201720182019120202021202220232024202512026
  • Recalls (3)

Registered facilities (5)

Recalls & enforcement

  • Class IIOngoing2026-06-03
    Due to manufacturing issues, reperfusion catheters may fractures
  • Class ITerminated2020-12-15
    The 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 ITerminated2017-06-09
    Penumbra 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.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “PENUMBRA, INC. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9072336-penumbra-inc/

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