Mikro-Cath Pressure Catheter 825-0101Recalls & reported problems
Millar Inc. · The Millar Mikro-Cath Cardiovascular Catheter is fitted with an ultra-miniature pressure sensor near the distal end. The sensor is side mounted at the catheter tip. The proximal end terminates in a connector. The pressure sensor produces an electrical output signal which varies in direct proportion to the magnitude of sensed pressure or sound. · 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 00868924000205), received between Mar 30, 2022 and Mar 30, 2022 — classified as 1 malfunction.
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
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 30, 2022Break
THE CATHETER BROKE IN TEH PATIENTS BODY AFTER THE PHYSICIAN PULLED THE CATHETER BACK TO THE AO. THE CATHETER WAS PULLED BACK JUST A LITTLE BIT AND THE TIP DID NOT PULL BACK AS THE CATHETER WAS PULLED BACK. IT WAS OBSERVED THE MILLAR CATHETER WAS BROKEN AT APPROXIMATELY 15 CM FROM THE END. PINCHED GUIDE CATHETER AND PULLED ALL OUT EASILY WITH NO RESISTANCE.
Patient problems: Foreign Body In Patient
MAUDE report 13957339 ↗
Other Transducer, Pressure, Catheter Tip devices
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- TruWave, VAMP T001744MEdwards Lifesciences LLC · Transducer, Pressure, Catheter Tip1 recall6 reports
- Comet H7493932430Boston Scientific Corporation · TRANSDUCER, PRESSURE, CATHETER TIP56 reports
- TRUWAVE PXMK2041Edwards Lifesciences LLC · TRANSDUCER, PRESSURE, CATHETER TIP1 recall4 reports
- TRUWAVE PX284Edwards Lifesciences LLC · TRANSDUCER, PRESSURE, CATHETER TIP1 recall3 reports
- TRUWAVE, VAMP PLUS PXVP2260Edwards Lifesciences LLC · TRANSDUCER, PRESSURE, CATHETER TIP1 recall2 reports
- TRUWAVE, VAMP PLUS PXVP23X3Edwards Lifesciences LLC · TRANSDUCER, PRESSURE, CATHETER TIP1 recall2 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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