SmartView SW001URecalls & reported problems
Microport Crm Srl · SmartView Connect App · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08031527019932), received between Aug 20, 2026 and Aug 20, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Displays Incorrect Message” (1 report).
1 other recall cover devices cleared under the same FDA submission (P950029); they may or may not involve this specific model.
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.
Reports received per month
Most reported problems
Device problems
- Device Displays Incorrect Message1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 20, 2026Device Displays Incorrect Message
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50339041 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P950029. One submission often covers many models, so check the product and lot details in each record.
- Z-2235-2009 · Sep 23, 2008 · TerminatedSorin Group Reply DR Rate responsive dual-chamber pacemaker. Made in Italy by: Sorin BioMedica CRM S.r.l., Via Crescentino s.n., 13040 Saluggia (VC) Italy. ELA Medical, Inc., 14
Other Transmitters And Receivers, Physiological Signal, Radiofrequency devices
- NA ORG-9110ANihon Kohden Corporation · TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY272 reports
- NA GZ-130PNihon Kohden Corporation · TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY1 death203 reports
- NA ORG-9100ANihon Kohden Corporation · TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY106 reports
- Midmark Midmark Digital ECGCardioline SPA · Transmitters And Receivers, Physiological Signal, Radiofrequency1 recall1 report
- Vital Sync VITALSYNCSW03Covidien LP · TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY1 recall1 report
- Vital Sync VITALSYNCSW03Covidien LP · TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY1 recall1 report
- VistaCenter 6200-01Vital Connect, Inc. · Transmitters And Receivers, Physiological Signal, Radiofrequency1 recall1 report
- BioButton v3 (BBN-r, different batch) BIOST06040Biointellisense, Inc. · Transmitters And Receivers, Physiological Signal, Radiofrequency1 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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