Early Bird Bleed Monitoring System FG001-02Recalls & reported problems
Saranas Inc. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00866532000419), received between Jan 16, 2023 and Jan 16, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).
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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Aug 10, 2022Class IIOpen, Classified
Bleed monitoring system device design error, causing the device to not power on and complete the series of self-tests so instructions for use being updated to include device check before use ensure that the device is functioning appropriately.
Z-1684-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method1
Patient problems
- Low Blood Pressure/ Hypotension1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 16, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
THE EVENT OCCURRED ON (B)(6) 2022 AT (B)(6). THE COMPLAINT WAS RECEIVED ON OCTOBER 6, 2022 BY THE SARANAS SALES REPRESENTATIVE WHO WAS NOT PRESENT AT THE CASE. THE FACILITY REPORTING PERSON INDICATED THAT PRIOR TO THE PROCEDURE, THE SARANAS EARLY BIRD BLEED MONITORING SYSTEM (8FR) WAS PREPARED AT THE SCRUB TABLE PER THE INSTRUCTIONS FOR USE (IFU). THE EARLY BIRD BATTERY ISOLATION PULL TAB WAS REMOVED TO ACTIVATE THE DEVICE, AND A GREEN BLINKING LIGHT WAS OBSERVED ON THE DEVICE USER INTERFACE DISPLAY INDICATING THAT THE DEVICE WAS FUNCTIONING PROPERLY. THE DEVICE WAS TURNED OFF AND SUBSEQUENTLY IMPLANTED INTO THE PATIENT AS PER THE IFU. THE EARLY BIRD DEVICE WAS NOT TO BE ACTIVATED FOR BLEED MONITORING UNTIL AFTER THE MEDICAL PROCEDURE WAS PERFORMED. THE PATIENT WAS UNDERGOING A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. DURING THE TAVR PROCEDURE, INTERNAL BLEEDING EVENTS OCCURRED. IT WAS REPORTED THAT A BLEED HAD OCCURRED DUE TO A FAILED MANTA VASCULAR CLOSURE DEVICE IN THE COMMON LEFT FEMORAL ARTERY. ONE OF THE DOCTORS ALSO REPORTED THAT THERE MAY HAVE BEEN SOME BLEEDING FROM THE EPIGASTRIC ARTERY. AS SUCH, THE PHYSICIANS PERFORMED A BALLOON TAMPONADE OF THE LEFT FEM
Patient problems: Low Blood Pressure/ Hypotension
MAUDE report 16173395 ↗
Other Intravascular Bleed Monitor devices
- Early Bird Bleed Monitoring System FG001-01Saranas Inc. · Intravascular Bleed Monitor1 recall1 death2 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 · each recall links to the FDA recall notice
- 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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