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Sign in to claim this brandPENUMBRA, INC.
United States·US-MF-000008514
Last updated September 17, 2026
Information
- Country
- United States
- Address
- One Penumbra Place, Alameda, United States
- Website
- penumbrainc.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Mary Rose
- EUDAMED SRN
- US-MF-000008514
- FDA FEI Number
- 3013758550
- DUNS Number
- 191077671
Catalogue (1506)
Page 5 of 31| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Penumbra Coil 400 | 4006U0406-A | FDA UDI | Class II | Active |
| Smart Coil | 400SMTSTD4H12 | FDA UDI | Class II | Active |
| Smart Coil | 400SMTSFT0830 | FDA UDI | Class II | Active |
| PX SLIM Delivery Microcatheter | PXSLIM130-B | FDA UDI | Class II | Active |
| LP Coil System | RBYLP0630-B | FDA UDI | Class II | Active |
| Smart Coil | 400SMTSTD1030 | FDA UDI | Class II | Active |
| Swift Coil System | 400SWPC45-A | FDA UDI | Class II | Active |
| LP Coil System | RBYPCLP05 | FDA UDI | Class II | Active |
| Ace | 5MAXACE068L127 | FDA UDI | Class II | Active |
| Ruby XL Coil System | RBYPODXL0530-A | FDA UDI | Class II | Active |
| Smart Coil | 400SMTSTD1845 | FDA UDI | Class II | Active |
| Indigo System | CAT8XTORQ115 | FDA UDI | Class II | Active |
| Ruby XL Coil System | RBYXL3255-A | FDA UDI | Class II | Active |
| Swift Coil System | 400SWPC01-A | FDA UDI | Class II | Active |
| Indigo System | SEP750-A | FDA UDI | Class II | Active |
| Penumbra Coil 400 | 4004C0935 | FDA UDI | Class II | Active |
| Indigo System | LITNGFXT80H1-A | FDA UDI | Class II | Active |
| Penumbra Coil 400 | 4002C1245-A | FDA UDI | Class II | Active |
| Penumbra Coil 400 | 4002C0415-A | FDA UDI | Class II | Active |
| Benchmark | BMK6F115M-A | FDA UDI | Class II | Active |
| Penumbra Coil 400 | 4004C1450 | FDA UDI | Class II | Active |
| Penumbra System | 5MAXJET7B-A | FDA UDI | Class II | Active |
| Smart Coil | 400SMTXSFT0105 | FDA UDI | Class II | Active |
| Indigo System | LITNGBT6X150-A | FDA UDI | Class II | Active |
| LP Coil System | RBYLP0201 | FDA UDI | Class II | Active |
| Smart Coil | 400SMTSTD0825 | FDA UDI | Class II | Active |
| LP Coil System | RBYLP0304 | FDA UDI | Class II | Active |
| Smart Coil | 400SMTXSFT1H06 | FDA UDI | Class II | Active |
| Smart Coil | 400SMTHXSFT2H03 | FDA UDI | Class II | Active |
| Smart Coil | 400SMTSFT1330 | FDA UDI | Class II | Active |
| Benchmark | BMK6F95SIM120 | FDA UDI | Class II | Active |
| RUBY Coil | RBY2C0415-B | FDA UDI | Class II | Active |
| Artemis | AP21-A | FDA UDI | Class II | Active |
| Benchmark MAX System | BMX7F115MSIM130-A | FDA UDI | Class II | Active |
| LP Coil System | RBYLP0530 | FDA UDI | Class II | Active |
| Smart Coil | 400SMTHXSFT0404 | FDA UDI | Class II | Active |
| LP Coil System | RBYLP0103 | FDA UDI | Class II | Active |
| PX SLIM Delivery Microcatheter | PXSLIM160045-A | FDA UDI | Class II | Active |
| Neuron | PNS6F105SIM | FDA UDI | Class II | Active |
| Benchmark | BMK6F105 | FDA UDI | Class II | Active |
| Indigo System | CAT8XTORQ115KIT-B | FDA UDI | Class II | Active |
| RUBY Coil | RBY2C0612-B | FDA UDI | Class II | Active |
| Penumbra Coil 400 | 4004J2 | FDA UDI | Class II | Active |
| Penumbra Coil 400 | 4002C0740 | FDA UDI | Class II | Active |
| RUBY Coil | RBY2C1857-A | FDA UDI | Class II | Active |
| Indigo System | SEP6 | FDA UDI | Class II | Active |
| Penumbra Coil 400 | 4006C0202 | FDA UDI | Class II | Active |
| RUBY Coil | RBY4C0860-B | FDA UDI | Class II | Active |
| Neuron | PNS5F130BER-R | FDA UDI | Class II | Active |
| Penumbra Coil 400 | 400PAC45 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
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FDA Recalls (10)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Dec 15, 2020 | Z-0848-2021 | — | 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. |
| Dec 15, 2020 | Z-0851-2021 | — | 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. |
| Dec 15, 2020 | Z-0850-2021 | — | 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. |
| Dec 15, 2020 | Z-0849-2021 | — | 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. |
| Jun 9, 2017 | Z-2702-2017 | — | 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. |
| Mar 4, 2011 | Z-1906-2011 | — | 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. |
| Oct 25, 2010 | Z-0428-2011 | — | 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. |
| Sep 22, 2009 | Z-0001-2010 | — | 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. |
| Jul 2, 2009 | Z-2049-2009 | — | 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. |
| Jul 1, 2009 | Z-2313-2009 | — | terminated | Misbranding--Some products may be identified with the wrong ID band content 'Neuron 6F 070' instead of 'Neuron 6F delivery' |
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Penumbra Inc. Roseville, CA · US FEI 3016591327