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RESEARCH DRAFT

Research draft. Conclusions may change; review the sources and limitations before relying on them.

RESEARCH DRAFT · NOT A VERIFIED CONCLUSION

Five device identifiers. Two safety notices. One completed repair is not a complete checklist.

An identifier-level comparison links the same five Impella controller models to mechanical and cybersecurity notices with different corrective actions.

research_draftUpdated 2026-09-080 recorded actions
Conceptual generated illustration of documents and civic architectureCONCEPTUAL ILLUSTRATION

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2Recorded evidence rows
0Investigation actions
5Review limitations
0Recorded answers

What this page shows

Comparing the affected-product tables in two FDA notices yields five matching UDI device identifiers: 00813502010022, 00813502010985, 00813502011401, 00813502013030 and 00813502010442. These identify device models, not five individual devices or five hospitals. The purge-retainer notice describes a mechanical issue addressed through manufacturer servicing. The cybersecurity notice describes a separate issue and manufacturer-directed network mitigation. A record that one action is complete therefore cannot, by itself, establish completion of the other. The useful construction is a per-asset action matrix: join a hospital's inventory to affected identifiers, check serial-number eligibility and record evidence of each applicable corrective action separately. This publication establishes the model-level overlap, not the condition or remediation status of any installed device. Follow the current official notices and manufacturer guidance for operational decisions.

Recorded evidence

FDA · device recall notice
Automated Impella Controllers — purge-retainer issue and affected UDI table
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FDA · cybersecurity correction notice
Automated Impella Controller — cybersecurity issue and affected UDI table
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Limitations & review notes

  • Research draft. Conclusions may change; review the sources and limitations before relying on them.
  • Restored archival research draft: not independently reverified for this republication and not actively monitored. Check the linked originals and dated scope before relying on it.
  • These recalls have already been discussed together in public coverage. The contribution here is an explicit identifier-level overlap and separate-action checklist, not a claim of a previously unknown recall cluster.
  • A UDI-DI identifies a model/version, not a unique physical asset. Serial-number scope, service records and newer notices must be checked before drawing asset-level conclusions.
  • The cybersecurity notice reports no related cyberattacks or patient harm at the time of that communication. No attack or failure of a completed repair is alleged.

Questions this connection opens

  1. For the five Impella controller UDI-DIs shared by the purge-retainer and cybersecurity FDA notices, construct a separate row for each corrective action. Join an authorized hospital inventory by UDI-DI and serial number, then check service and mitigation evidence. Which assets have only one action documented? Do not infer missing remediation from missing records.
  2. Across FDA device notices, which models require independent mechanical, software and cybersecurity corrections? Deduplicate updates to the same notice, distinguish model overlap from serial-number overlap, and generate a source-linked checklist rather than one undifferentiated recalled flag.
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