FDA approvals and recalls

Stroke: FDA Approvals, Recalls, 510(k) Clearances and Side Effect Reports

What the US Food and Drug Administration has cleared, approved and recalled on this topic, and the side effects people report.

Each number has its full source under its own list below.

Drug recalls

18 recalls (since 1 Jan 2023). Recalls of medicines for this topic, newest first.

At the source

Source: openFDA, Drug recall enforcement reports, since 1 Jan 2023. Retrieved 12 Nov 2026.

Device recalls

9 recalls (since 1 Jan 2023). Recalls of medical devices for this topic, newest first.

At the source

  • Catheter, Thrombus Retriever

    Reason: Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result, this could potential create a breach in the sterile barrier.

    Z-1234-2025

  • Cardiovascular Procedure Kit

    Reason: Fluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the required grey micro drip chamber. The macro drip chamber delivers three times more fluid per drop than th…

    Z-0765-2025

  • Catheter, Thrombus Retriever

    Reason: Due to Retrieval Device product labels stating the incorrect expiration dates that (5 years instead of 3 years) which extends beyond their true expiration date.

    Z-3157-2024

  • Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment

    Reason: Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may ex…

    Z-1902-2024

  • Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment

    Reason: Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI ST72 standard, so these devices may ex…

    Z-1905-2024

  • Catheter, Percutaneous

    Reason: Their is the potential for distal tip separation at the proximal marker band of the delivery catheters

    Z-1614-2024

  • Cardiovascular Procedure Kit

    Reason: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

    Z-2165-2023

  • Cardiovascular Procedure Kit

    Reason: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

    Z-2302-2023

  • Cardiovascular Procedure Kit

    Reason: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

    Z-2303-2023

Source: openFDA, Medical device recalls, since 1 Jan 2023. Retrieved 12 Nov 2026.

510(k) clearances

7 devices cleared (since 1 Jan 2023). Devices the FDA cleared to sell in the US, newest first.

At the source

Source: openFDA, Premarket notifications (510(k)) cleared, since 1 Jan 2023. Retrieved 12 Nov 2026.

Side effects people report

1,644 side effect reports (reports received since 1 Jan 2023). The reactions named most often in reports about medicines used for this topic.

At the source
  1. 1Angioedema105 reports
  2. 2Cerebral haemorrhage97 reports
  3. 3Neurological decompensation76 reports
  4. 4Haemorrhagic transformation stroke70 reports
  5. 5Acute kidney injury52 reports
  6. 6Ischaemic stroke51 reports
  7. 7Vomiting50 reports
  8. 8Haemorrhage intracranial49 reports
  9. 9Pneumonia49 reports
  10. 10Cerebral infarction40 reports

Anyone can send a report. A report does not prove that the medicine caused the reaction, and the counts do not show how often it happens.

Source: openFDA, FDA Adverse Event Reporting System (FAERS), reports by reaction, reports received since 1 Jan 2023. Retrieved 12 Nov 2026.

Benchmarks on stroke

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