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Simulus™ 850Recalls & reported problems

Medtronic, Inc. · ACCY KIT 850 SIMULUS SEMI-RIGID RING/B · Class 1

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Jan 14, 2020Open, Classified

    Demonstration Simulus Reusable Sizer Accessory Kits were being incorrectly sourced to customers. The demonstration product (product used within a wet lab) could have come in contact with non-human (porcine) tissue.

    Z-1450-2020 · Root cause: Nonconforming Material/Component · FDA record ↗

Other SIZER, HEART-VALVE, PROSTHESIS devices

All SIZER, HEART-VALVE, PROSTHESIS devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.