SAVI® 00884450434413Recalls & reported problems
Merit Medical Systems, Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884450434413), received between Jan 7, 2021 and Jan 7, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 7, 2021Detachment of Device or Device Component; Detachment of Device or Device Component
THE ACCOUNT ALLEGES THAT DURING REMOVAL OF THE DEVICE, A PART OF IT BROKE OFF. THE DEVICE WAS SURGICALLY REMOVED FROM THE PATIENT.
Patient problems: Foreign Body In Patient
MAUDE report 11132709 ↗
Other System, applicator, radionuclide, remote-controlled devices
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- Advanced Gynecological Applicator 126013-01Nucletron B.V. · System, applicator, radionuclide, remote-controlled1 recall0 reports
- Advanced Gynecological Applicator 126023-01Nucletron B.V. · System, applicator, radionuclide, remote-controlled1 recall0 reports
- Geneva 152019-00Nucletron B.V. · System, applicator, radionuclide, remote-controlled1 recall0 reports
- Fletcher CT/MR Shielded Applicator 110980-00Nucletron B.V. · System, applicator, radionuclide, remote-controlled1 recall0 reports
- Geneva 152020-00Nucletron B.V. · System, applicator, radionuclide, remote-controlled1 recall0 reports
- Geneva 152011-00Nucletron B.V. · System, applicator, radionuclide, remote-controlled1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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