PEDIATRIC FLOW PROBE 1/4" X 3/32" 104298Recalls & reported problems
Thoratec Switzerland GmbH · Class 2
Data updated Oct 18, 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 07640135140146), received between May 19, 2021 and May 19, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (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
- Device Markings/Labelling Problem1
- Inadequate Instructions for Healthcare Professional1
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.
MalfunctionMay 19, 2021Inadequate Instructions for Healthcare Professional; Device Markings/Labelling Problem; Inadequate Instructions for Healthcare Professional; Device Markings/Labelling Problem
IT WAS REPORTED THAT THE PRODUCT WAS DEFECTIVE OUT OF THE BOX. THE FLOW PROBE WAS PLACED BACK IN THE BOX AN LABELED AS DEFECTIVE. THE FLOW PROBE DID NOT INCLUDE A MANUFACTURE LABEL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11849438 ↗
Other Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type devices
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- CentriMag™ 102953Thoratec Switzerland GmbH · Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type1 recall35 deaths209 reports
- Impella Impella LD AIC Pump SetAbiomed, Inc. · Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type3 recalls9 deaths57 reports
- NA HY8M65R2Medtronic, Inc. · PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE4 recalls0 reports
- Custom Perfusion System HY8L55R5Medtronic, Inc. · PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE3 recalls3 reports
- Custom Perfusion System BB6U40R11Medtronic, Inc. · PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE2 recalls1 report
- NA BB8C33R6Medtronic, Inc. · Pump, blood, cardiopulmonary bypass, non-roller type2 recalls0 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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