Sizer, Heart-Valve, Prosthesis
FDA adverse event reports and recall history for sizer, heart-valve, prosthesis (product code DTI), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 200
- Deaths
- 0
- Injuries
- 39
- Malfunctions
- 157
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2020-02-14Open, ClassifiedNonconforming Material/Component
Medtronic Simulus 750 Flexible Ring/Band Accessory Kit - Product Usage: Used to size a patient's mitral or tricuspid valve in cardiac procedures.
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.
- 2020-02-14Open, ClassifiedNonconforming Material/Component
Medtronic Simulus 850 Semi Rigid Ring/Band Accessory Kit Used to size a patient's mitral or tricuspid valve in cardiac procedures.
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.
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