TRIPOD Heart Stabilizer Nylon Blwr/Occ STO-3BC4SRecalls & reported problems
KDL Medical, Inc. · Heart Stabilizer, Nylon Textured Feet w/ Blower, Occluders · Class 1
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 00899054002531), received between Jan 11, 2023 and Jan 11, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (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
- Loss of or Failure to Bond1
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.
MalfunctionJan 11, 2023Loss of or Failure to Bond; Loss of or Failure to Bond
AS REPORTED - ONE OF THE STABILIZER FEET CAME LOOSE FROM THE BARREL DURING THE PROCEDURE. STABILIZER WAS REMOVED AND A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT HARM REPORTED RESULTING FROM THIS COMPLAINT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16142179 ↗
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- Acrobat-I Stabilizer OM-10000Maquet Cardiovascular LLC · Stabilizer,Heart1 recall1 death51 reports
- Acrobat SUV Stabilizer OM-9000ZMaquet Cardiovascular LLC · Stabilizer,Heart1 recall19 reports
- OCTOPUS® TS2000Medtronic, Inc. · stabilizer,heart1 recall15 reports
- Herc Flex Universal Stabilizer Arm T401163Terumo Cardiovascular Systems Corporation · Stabilizer, Heart1 recall10 reports
- Acrobat V Stabilizer OM-9100SMaquet Cardiovascular LLC · Stabilizer,Heart1 recall7 reports
- OCTOPUS® TSMICS1Medtronic, Inc. · Stabilizer, heart1 recall5 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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