Penumbra Coil 400 Embolization Coil

Penumbra Inc.

Not determinedIndexed from FDA records

MR Conditional — conditions not yet documented here. We have a Conditional label for this device but the specific scan conditions (field strength, SAR / B1+rms, monitoring requirements) aren't in our records yet. Treat as Not determined and let your MRI team confirm before any scan.

Here's what to do next — you're going to be okay:

  1. Bring your device card (the wallet card from your surgery) to your appointment. Your MRI team can identify any device from it.
  2. Call the manufacturer's patient line — the number is on your card. They answer device questions every day.
  3. Tell your imaging center about your device when you book. They screen every patient before every scan — no one will scan you unless it's safe.

Don't schedule an MRI based on this page alone — your MRI team verifies every device.

What this means for you

MR Conditional — but the conditions are not yet on file. The label exists. The scan rules (field, SAR, monitoring) do not. Treat as Not determined and let your MRI team confirm before any scan.

Here's what to do next — you're going to be okay:

  1. Bring your device card (the wallet card from your surgery) to your appointment. Your MRI team can identify any device from it.
  2. Call the manufacturer's patient line — the number is on your card. They answer device questions every day.
  3. Tell your imaging center about your device when you book. They screen every patient before every scan — no one will scan you unless it's safe.
Sign in to save implants to your account

For information only — your MRI team makes the final decision before any scan. They check every patient, every time.

✅This recall has been resolved
⚠️

FDA Recall Alert

Class I — Most Serious

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.

💡 What this means for you

This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.

7/1/2009 · View on FDA.gov

✅This recall has been resolved
⚠️

FDA Recall Alert

Class I — Most Serious

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.

💡 What this means for you

This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.

12/14/2020 · View on FDA.gov

✅This recall has been resolved
⚠️

FDA Recall Alert

Class I — Most Serious

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.

💡 What this means for you

This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.

12/14/2020 · View on FDA.gov

✅This recall has been resolved
⚠️

FDA Recall Alert

Class I — Most Serious

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.

💡 What this means for you

This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.

12/14/2020 · View on FDA.gov

✅This recall has been resolved
⚠️

FDA Recall Alert

Class I — Most Serious

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.

💡 What this means for you

This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.

12/14/2020 · View on FDA.gov

✅This recall has been resolved
⚠️

FDA Recall Alert

Class I — Most Serious

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.

💡 What this means for you

This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.

9/21/2009 · View on FDA.gov

✅This recall has been resolved
⚠️

FDA Recall Alert

Class I — Most Serious

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.

💡 What this means for you

This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.

6/8/2017 · View on FDA.gov

✅This recall has been resolved
⚠️

FDA Recall Alert

Class I — Most Serious

Misbranding--Some products may be identified with the wrong ID band content 'Neuron 6F 070' instead of 'Neuron 6F delivery'

💡 What this means for you

This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.

6/30/2009 · View on FDA.gov

✅This recall has been resolved
⚠️

FDA Recall Alert

Class I — Most Serious

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.

💡 What this means for you

This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.

3/3/2011 · View on FDA.gov

✅This recall has been resolved
⚠️

FDA Recall Alert

Class I — Most Serious

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.

💡 What this means for you

This is the most serious type of recall. The FDA determined this product could cause serious health consequences. Talk to your doctor about what this means for you.

10/24/2010 · View on FDA.gov

⚕️ This information is for reference only. A recall does not necessarily mean your device needs removal. Consult your healthcare provider for medical advice.

Regulatory Info

510(k) NumberK160832 ↗
Clearance Date4/19/2016
Product CodeHCG
✅
All Recalls Resolved

10 past recalls — all corrective actions completed

Data sourced from openFDA. This is for reference only — consult your healthcare provider for medical advice.

Category

Neuro

Body Region

Aneurysm Coils

MRI Conditions

MRI conditional up to 3.0T; Conditional 5

🔔 Get Recall Alerts for Penumbra Coil 400 Embolization Coil
Get notified if the FDA issues a recall for this specific implant

Indexed from FDA records. Conditions on this page have not been verified against the manufacturer's instructions for use.