TRIPOD Heart Stabilizer-Nylon Fastract STB-30C4SRecalls & reported problems
KDL Medical, Inc. · Heart Stabilizer, Nylon Textured Feet · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00899054002449), received between Mar 9, 2018 and Nov 14, 2019 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (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
- Break1
- Component Missing1
- Device Operates Differently Than Expected1
Patient problems
- No Consequences Or Impact To Patient2
- No Patient Involvement1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 14, 2019Component Missing
AS REPORTED - STABILIZER WAS MISSING ONE FOOT AND O-RING. THIS WAS NOTICED PRIOR TO USE AND ANOTHER STABILIZER WAS USED WITHOUT HARM TO THE PATIENT. CHASE MEDICAL WAS NOTIFIED OF THE COMPLAINT ON 10/23/2019 BY THE SALES REPRESENTATIVE WITH MBA MEDICAL. THE EVENT OCCURRED AT (B)(6).
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9324815 ↗MalfunctionMar 15, 2018Break
AS DESCRIBED - RELATED TO A STABILIZER, "IT WOULDN'T STAY TOGETHER". THE EVENT OCCURRED PRIOR TO USE AND THERE WAS NO PATIENT HARM. ANOTHER STABILIZER WAS USED FOR THE PROCEDURE. CHASE MEDICAL WAS NOTIFIED OF THIS COMPLAINT ON (B)(6) 2018 BY (B)(6), (B)(4). THIS INCIDENT OCCURRED AT (B)(6) HOSPITAL, (B)(6).
Patient problems: No Patient Involvement
MAUDE report 7343780 ↗MalfunctionMar 9, 2018Device Operates Differently Than Expected
AS DESCRIBED - "ARM WOULDN'T HOLD ON STABILIZER DURING SURGERY". THERE WAS NO HARM TO THE PATIENT AND THEY JUST USED ANOTHER STABILIZER. CHASE MEDICAL WAS NOTIFIED OF THIS COMPLAINT ON (B)(6) 2018 BY CUSTOMER, (B)(6). THIS INCIDENT OCCURRED AT (B)(6) GENERAL HOSPITAL.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7327181 ↗
Other Stabilizer,Heart devices
- Acrobat-I Stabilizer OM-10000ZMaquet Cardiovascular LLC · Stabilizer,Heart2 recalls120 reports
- Acrobat-i Positioner XP-5000ZMaquet Cardiovascular LLC · Stabilizer,Heart2 recalls34 reports
- 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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