Penumbra Recalls

5 recalls on record in the United States

medical: 5
medical Class I
2017-07-26

Penumbra Inc. recalls Penumbra 3D Revascularization Device It is indicated for us

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.

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medical Class I
2021-01-27

Penumbra Inc. recalls Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Asp

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.

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medical Class I
2021-01-27

Penumbra Inc. recalls Penumbra JET 7 Reperfusion Catheter REF 5MAXJET7 The Penu

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.

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medical Class I
2021-01-27

Penumbra Inc. recalls Penumbra JET 7MAX KIT Penumbra JET 7 Reperfusion Catheter+ M

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.

View recall details →
medical Class I
2021-01-27

Penumbra Inc. recalls Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Asp

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.

View recall details →