ACIST Navvus® Catheter 014667Recalls & reported problems
Acist Medical Systems, Inc. · Navvus Catheter, p/n 701481-010 · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10841716101240), received between Apr 19, 2019 and Oct 13, 2021 — classified as 1 injury, 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
- Detachment of Device or Device Component1
- Device Damaged by Another Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 13, 2021Break; Break
DURING A FRACTIONAL FLOW RESERVE (FFR) PROCEDURE USING THE ACIST RAPID EXCHANGE FFR SYSTEM, MODEL RXI, AND NAVVUS CATHETER, THE NAVVUS CATHETER TIP BROKE WITHIN THE PATIENT. THE TIP WAS REMOVED BY THE PHYSICIAN AND THERE WAS NO INJURY TO THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12624950 ↗MalfunctionApr 19, 2019Detachment of Device or Device Component; Device Damaged by Another Device; Detachment of Device or Device Component; Device Damaged by Another Device
DURING AN INTERVENTIONAL PROCEDURE USING THE ACIST RAPID EXCHANGE FFR SYSTEM, MODEL RXI, WITH NAVVUS CATHETER, ON A PATIENT WITH CALCIFIED AND TORTUOUS TARGET ARTERY, THE NAVVUS CATHETER TIP SEPARATED DURING USE. THE USER WAS ABLE TO RETRIEVE THE TIP USING A SNARE DEVICE. THERE WAS NO REPORTED INJURY TO THE PATIENT. A NEW NAVVUS CATHETER WAS USED TO COMPLETE THE PROCEDURE WITH NO ADDITIONAL ISSUES.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8532010 ↗
Other Transducer, Pressure, Catheter Tip devices
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- TRUWAVE, VAMP PLUS PXVP2284AT3Edwards Lifesciences LLC · TRANSDUCER, PRESSURE, CATHETER TIP1 recall9 reports
- 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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