CLASS I Device recall · Reported 26 Jul 2017 · FDA Enforcement Report
3D Revascularization Device It is indicated for used recalled
Penumbra is recalling 3D Revascularization Device It is indicated for used in the revascularization of patients, distributed nationwide in the US. The recall was initiated on 9 Jun 2017 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2702-2017
- FDA event ID
- 77571
- Recalling firm
- Penumbra, Alameda, CA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 9 Jun 2017
- FDA classified
- 20 Jul 2017
- Reported
- 26 Jul 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 9 Jun 2017 | Recall initiated by company | |
| 20 Jul 2017 | Classified by FDA | +41 days |
| 26 Jul 2017 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Penumbra 3D Revascularization Device It is indicated for used in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral-M1 and M2 segments) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
Where it was distributed
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
Nationwide ArizonaCaliforniaColoradoFloridaIndianaMassachusettsMichiganMinnesotaNevadaNew YorkOhioOklahomaPennsylvaniaSouth CarolinaTennesseeTexasUtahVirginiaWest Virginia
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lots C00644, C00645, C00646, C00717
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Penumbra
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|---|---|---|---|---|---|
| Device | CLASS II | System RED 68 Reperfusion Catheter recalled by Penumbra | Penumbra | Other | Nationwide |
| Device | CLASS I | JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing recalled | Penumbra | Other | Nationwide |
| Device | CLASS I | JET 7MAX KIT Penumbra JET 7 Reperfusion Catheter+ MAX recalled | Penumbra | Other | Nationwide |
| Device | CLASS I | JET 7 Reperfusion Catheter recalled by Penumbra | Penumbra | Other | Nationwide |
| Device | CLASS I | JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing recalled | Penumbra | Other | Nationwide |
Other Heart & Vascular Devices recalls
All 6,212| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Imager II Angiographic Catheters M001314001 Imager recalled | Boston Scientific | Other | Nationwide |
| Device | CLASS II | Olympus EZDilate Endoscopic Balloon Dilator Wired-guided recalled | Olympus Corporation of the Americas | Other | PA |
| Device | CLASS II | Cardioroot Woven Collagen Coated Vascular Graft recalled | SAS Intervascular | Other | Nationwide |
| Device | CLASS II | Automated Impella Controller (AIC) recalled by Abiomed | Abiomed | Potency & Assay | Nationwide |
| Device | CLASS I | DuoGlide Short-Term Straight Dialysis Catheter recalled | Bard Access Systems | Other | 50 states |