The Recall Desk

FDA (Devices) recall action 86989

Penumbra Inc. recalled 4 products on 2021-01-27

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2021-01-27
Critical
4
Units
30,882

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–4 of 4

  • CriticalFDA (Devices)··2021-01-27

    Penumbra JET 7 Reperfusion Catheter Recalled for Potential Tip Damage

    Penumbra Inc. is recalling 3,368 JET 7 Reperfusion Catheters because the distal tip may become damaged during use, posing a risk of vessel damage and patient injury or death.

    Product
    Penumbra JET 7 Reperfusion Catheter REF 5MAXJET7 The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspiration from the Aspiration Pump to the site of occlusion to assist in the…
    Category
    Distribution
    49 states
  • CriticalFDA (Devices)··2021-01-27

    Penumbra JET 7 Reperfusion Catheter Recalled for Potential Vessel Damage

    Penumbra Inc. is recalling JET 7 Reperfusion Catheters because distal tip damage could cause vessel injury or death during use.

    Product
    Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7KIT The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspiration from the Aspiration Pump…
    Category
    Distribution
    49 states
  • CriticalFDA (Devices)··2021-01-27

    Penumbra JET 7 Reperfusion Catheter Recalled for Potential Tip Damage

    Penumbra Inc. is recalling JET 7 Reperfusion Catheters because distal tip damage could cause vessel injury or death during use.

    Product
    Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF 5MAXJET7L138KIT The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers aspiration from the Aspiration…
    Category
    Distribution
    49 states
  • CriticalFDA (Devices)··2021-01-27

    Penumbra JET 7MAX Kits Recalled for Potential Vessel Damage Risk

    Penumbra Inc. is recalling JET 7MAX Kits because catheter tip damage during use could cause vessel damage, leading to patient injury or death.

    Product
    Penumbra JET 7MAX KIT Penumbra JET 7 Reperfusion Catheter+ MAX Delivery Device + Hi-Flow Aspiration Tubing REF J7XKIT132 The Penumbra JET 7 Reperfusion Catheter with Xtra Flex technology (JET 7 Xtra Flex) is a component of the Penumbra system. JET 7 Xtra Flex delivers…
    Category
    Distribution
    49 states