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Adverse-event reports (MAUDE)

Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history
InitiatedRecall #ClassStatusReasonQuantityLink basis
2017-06-09Z-2702-2017Class ITerminatedPenumbra 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.Distribution: Nationwide Distribution to the following states: AZ, CA, CO, FL, IN, MA, MI, MN, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WV155 unitsclearance family
Regulatory clearances
  • 510(k)K162901Substantially equivalent (SESE) · 2017-04-20clearance family
  • 510(k)K160449Substantially equivalent (SESE) · 2016-05-25clearance family

Predicate lineage

Cited as predicate by: K242033

Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2021-06-21NAINo action indicatedPenumbra Inc.0
2021-06-21NAINo action indicatedPenumbra Inc.0
2017-02-13NAINo action indicatedPenumbra Inc.0
2017-02-13NAINo action indicatedPenumbra Inc.0
2016-02-23VAIVoluntary action indicatedPenumbra Inc.0
2016-02-23VAIVoluntary action indicatedPenumbra Inc.0
2015-08-04VAIVoluntary action indicatedPenumbra Inc.1
2015-08-04VAIVoluntary action indicatedPenumbra Inc.1
2015-07-15VAIVoluntary action indicatedPenumbra Inc.1
2015-07-15VAIVoluntary action indicatedPenumbra Inc.1
2014-04-30NAINo action indicatedPenumbra Inc.0
2014-04-30NAINo action indicatedPenumbra Inc.0
2012-02-27NAINo action indicatedPenumbra Inc.0
2012-02-27NAINo action indicatedPenumbra Inc.0
2010-08-24VAIVoluntary action indicatedPenumbra Inc.1
2010-08-24VAIVoluntary action indicatedPenumbra Inc.1
2009-12-31WLWarning LetterPenumbra Inc.—
2009-12-31WLWarning LetterPenumbra Inc.—
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