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Penumbra, Inc.

Active in EUDAMED

United Statesfrom SRN EUDAMED FDA SRN US-MF-000008514 FEI 3013758550

Devices
1,653
Registrations
EUDAMEDFDA
FDA recalls
122 ongoing

At a glance

Counted by deviCERTS from registry records

EU certificates

4 of 4 in force.

See certificates

Market reach

European Union
EUDAMED actor, 4 certificates
United States
FDA FEI, FDA recalls
Authorised rep.
Penumbra Europe GmbHDE

What Penumbra, Inc. makes

Penumbra, Inc. manufactures embolization implant kits, including neurovascular and non-neurovascular embolization coils, as well as coil detachment handles for precise vascular interventions. Their portfolio also includes thrombectomy suction catheters, vascular microcatheters, single-use guide-catheters, and software for managing aspiration during thrombectomy procedures. Surgical irrigation/aspiration systems are designed for intraoperative fluid control in vascular and neurovascular surgeries.

The company’s devices are classified under Class I and Class II regulations, with listings in the EU’s EUDAMED database and the FDA’s Unique Device Identifier (UDI) system. Penumbra, Inc. is headquartered in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue1,653

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Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
US-MF-000008514
FDA FEI number
3013758550
DUNS number
191077671
EU VAT number
05-0605598
EUDAMED status
Active
EUDAMED registered name
Penumbra, Inc.
EUDAMED abbreviated name
PEN
Registered address
One Penumbra Place, 94502, Alameda, United States
Phone
1-888-272-4606
PRRC contact
Mary Rose(public in EUDAMED)

EUDAMED certificates4

4 certificates4 valid, 0 expiredMDR 4next expiry 28 Mar 2028

EUDAMED certificates (4)

BSI Group The Netherlands B.V. 2797 4 certificates

  • MDR 739816 Active Reissued

    Quality management system EU MDR

    Issued
    17 Sep 2026
    Expires
    29 Nov 2031
    Valid from
    30 Nov 2026
  • MDR 781036 Active

    Technical documentation EU MDR

    Issued
    17 Mar 2025
    Expires
    16 Mar 2030
  • MDR 781037 Active Supplemented

    Technical documentation EU MDR

    Issued
    22 Jun 2026
    Expires
    26 Mar 2029
    Reason
    Other
  • MDR 739883 Active Supplemented

    Technical documentation EU MDR

    Issued
    22 Jun 2026
    Expires
    28 Mar 2028
    Reason
    Other

FDA recalls12

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 12 recalls initiated by PENUMBRA, INC., the earliest on 2009-07-01 and the most recent on 2026-07-24. By recorded status: 2 ongoing and 10 terminated. The reasons filed fall into these groups: mechanical integrity and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 1
  • 2018 0
  • 2019 0
  • 2020 4
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 2

5 initiated before 2017

Showing the 10 most recent of 12 recalls.

  • 2026

    • 24 Jul 2026 Z-3331-2026 Class II Ongoing Due to manufacturing issues reperfusion catheters may fracture. Distribution: US Nationwide distribution in the states of AL, CA, CO, FL, LA, NC, NY, TX, UT, WI. Submission numbers: K203440, K250690
    • 3 Jun 2026 Z-2770-2026 Class II Ongoing Due to manufacturing issues, reperfusion catheters may fractures Distribution: Worldwide - US Nationwide distribution including in the states and territories of AK, AL, AE, AZ, CA, CO, CT, FL, GA,…
      Full distribution text Worldwide - US Nationwide distribution including in the states and territories of AK, AL, AE, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, Puerto Rico and the countries of Brazil, Canada, Colombia, Ecuador, Indonesia, Israel, Lebanon, Mexico, Mongolia, Philippines, Saudi Arabia, Thailand, and United Arab Emirates.
      Submission number: K211411

  • 2020

    • 15 Dec 2020 Z-0848-2021 Class I Terminated 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. Distribution: Worldwide distribution: U.S. (nationwide) including states of: AL, AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI IA, ID,…
      Full distribution text Worldwide distribution: U.S. (nationwide) including states of: AL, AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO , MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. And O.U.S (countries) of: Canada, Chile, Colombia, Costa Rica, Dominican Republic, Hong Kong, Israel, Japan, Korea, Lebanon, Malaysia, Nepal, New Zealand, Oman, Panama, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand, United Arab Emirates, and Vietnam.
      Submission numbers: K190010, K202251, K191946
    • 15 Dec 2020 Z-0849-2021 Class I Terminated 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. Distribution: Worldwide distribution: U.S. (nationwide) including states of: AL, AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI IA, ID,…
      Full distribution text Worldwide distribution: U.S. (nationwide) including states of: AL, AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO , MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. And O.U.S (countries) of: Canada, Chile, Colombia, Costa Rica, Dominican Republic, Hong Kong, Israel, Japan, Korea, Lebanon, Malaysia, Nepal, New Zealand, Oman, Panama, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand, United Arab Emirates, and Vietnam.
      Submission numbers: K190010, K202251, K191946
    • 15 Dec 2020 Z-0850-2021 Class I Terminated 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. Distribution: Worldwide distribution: U.S. (nationwide) including states of: AL, AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI IA, ID,…
      Full distribution text Worldwide distribution: U.S. (nationwide) including states of: AL, AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO , MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. And O.U.S (countries) of: Canada, Chile, Colombia, Costa Rica, Dominican Republic, Hong Kong, Israel, Japan, Korea, Lebanon, Malaysia, Nepal, New Zealand, Oman, Panama, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand, United Arab Emirates, and Vietnam.
      Submission numbers: K190010, K202251, K191946
    • 15 Dec 2020 Z-0851-2021 Class I Terminated 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. Distribution: Worldwide distribution: U.S. (nationwide) including states of: AL, AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI IA, ID,…
      Full distribution text Worldwide distribution: U.S. (nationwide) including states of: AL, AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO , MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. And O.U.S (countries) of: Canada, Chile, Colombia, Costa Rica, Dominican Republic, Hong Kong, Israel, Japan, Korea, Lebanon, Malaysia, Nepal, New Zealand, Oman, Panama, Saudi Arabia, Singapore, South Africa, Taiwan, Thailand, United Arab Emirates, and Vietnam.
      Submission numbers: K190010, K202251, K191946

  • 2017

    • 9 Jun 2017 Z-2702-2017 Class I Terminated 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. 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,…
      Full distribution text Nationwide Distribution to the following states: AZ, CA, CO, FL, IN, MA, MI, MN, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WV
      Submission number: K162901

  • 2011

    • 4 Mar 2011 Z-1906-2011 Unclassified (pre-2012) Terminated The diameter of a component of the device is out of tolerance specification; the Delivery Pusher pull wire which secures the coil in place can prolapse and allow premature detachment of the coil. Distribution: Worldwide Distribution - USA (nationwide) and the countries in the European Union (Denmark, Germany, Italy, Netherlands,…
      Full distribution text Worldwide Distribution - USA (nationwide) and the countries in the European Union (Denmark, Germany, Italy, Netherlands, Slovakia, Slovenia, Spain, United Kingdom and Switzerland) and South Africa.
      Submission number: K103305

  • 2010

    • 25 Oct 2010 Z-0428-2011 Unclassified (pre-2012) Terminated Reperfusion catheter may fail at the mid-shaft joint and may break off. If the segment cannot be removed, it may result in blocked blood flow, requiring emergency medical treatment. Distribution: Worldwide Distribution: 17 consignees in the US, including in the states of CA, FL, HI, ID, IL, KY, MA, MS, NJ, NY, PA,…
      Full distribution text Worldwide Distribution: 17 consignees in the US, including in the states of CA, FL, HI, ID, IL, KY, MA, MS, NJ, NY, PA, and TX, 1 in Canada and 21 in the EU countries of France, Germany, Hungary, Italy, Norway, Slovenia, Spain, and the United Kingdom.
      Submission number: K072718

  • 2009

    • 22 Sep 2009 Z-0001-2010 Unclassified (pre-2012) Terminated Failure-- product can kink or ovalize, which may result in difficulty in catheter advancement or delivery of other devices and damage to catheter, which could lead to patient injury or death as a result of portions being retained in the patient. Distribution: Worldwide Distribution -- USA, Canada, Hong Kong, Chile, the UK, Denmark, Norway, Sweden, Finland, Netherlands, Germany,…
      Full distribution text Worldwide Distribution -- USA, Canada, Hong Kong, Chile, the UK, Denmark, Norway, Sweden, Finland, Netherlands, Germany, Switzerland, Austria, and Spain.
      Submission number: K082290
Show all 12 recalls

  • 2009

    • 2 Jul 2009 Z-2049-2009 Unclassified (pre-2012) Terminated Leakage-- Due to a manufacturing error, some products may have a fold in the innermost layer, causing disruption in the layering process and may result in blow holds or exposed wire braids, which may result in further damage. Distribution: Worldwide Distribution -- US (IA, NJ, NY and VA), and Canada. Submission number: K083125
    • 1 Jul 2009 Z-2313-2009 Unclassified (pre-2012) Terminated Misbranding--Some products may be identified with the wrong ID band content 'Neuron 6F 070' instead of 'Neuron 6F delivery' Distribution: CA, FL, NC, MI, MO, VA, AZ, CT, IA, NY, and CO, Foreign: Germany and Australia. Submission number: K070970

Sites1

Frequently asked questions

How many devices does PENUMBRA, INC. have in the registry?

The registry currently lists 1653 devices for PENUMBRA, INC.. Devices recorded under merged duplicate company entries are counted once.

Which registries list PENUMBRA, INC.'s devices?

Among its 50 most recently registered devices, PENUMBRA, INC. has devices listed in EUDAMED (49 devices) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.

What risk classes do PENUMBRA, INC.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for PENUMBRA, INC.'s devices are Class II and Class III. Each device page shows its own class and authorisation.

Are there FDA recall records for PENUMBRA, INC.?

FDA recall records list 12 recalls initiated by PENUMBRA, INC., the most recent initiated on 24 Jul 2026. 2 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What EUDAMED certificates are recorded for PENUMBRA, INC.?

EUDAMED lists 4 certificates for PENUMBRA, INC. (quality management system; technical documentation) under MDR. 1 is recorded with the status issued. The most recent was issued on 17 Sep 2026.

What are the newest devices from PENUMBRA, INC. in the registry?

The most recently registered devices listed for PENUMBRA, INC. include INDIGO® Aspiration System, swiftPAC Coil, 30 cm, Penumbra Coil 400 Curve Extra Soft 3 mm x 4 cm and Packing Coil 5 cm.

Generated automatically from registry data and not verified by a human reviewer.