TRUWAVE T001709ARecalls & reported problems
Edwards Lifesciences LLC · PRESSURE MONITORING SET · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07460691947610), received between Dec 29, 2025 and Dec 29, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
1 other recall cover devices cleared under the same FDA submission (K171996, K183413); they may or may not involve this specific model.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Oct 4, 2023Open, Classified
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
Z-0413-2024 · Root cause: Device Design · FDA record ↗
Most reported problems
Device problems
- Detachment of Device or Device Component1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
AS REPORTED, DURING USE IN PATIENT, THIS DISPOSABLE PRESSURE TRANSDUCER TUBING BROKE, CAUSING MINIMAL BLEEDING FROM THE ARTERY. THIS CAUSED A DISRUPTION IN THE PROCEDURE; THE DEVICE WAS REPLACED WITH A NEW UNIT AND THE ISSUE WAS SOLVED. AS PER CUSTOMER OPINION, THE FAILURE APPEARED TO BE RELATED TO MATERIAL FATIGUE OR A MANUFACTURING DEFECT. THERE WAS NO ALLEGATION OF PATIENT INJURY. AS PER IMAGE EVALUATION, PRESSURE TUBING WAS DETACHED RATHER BROKEN. PATIENT DEMOGRAPHICS WERE NOT PROVIDED.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 23905192 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K171996, K183413. One submission often covers many models, so check the product and lot details in each record.
- Z-0414-2024 · Oct 4, 2023 · Open, ClassifiedTruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 in (173cm) PXAVMP3: x3 (3cc)/VAMP PXVK0364:(3cc)/VAMP 96in (241cm); PXVK0853: x3 (3cc)/VAMP 76in (193cm)
Other Transducer, Pressure, Catheter Tip devices
- TRUWAVE PX260Edwards Lifesciences LLC · TRANSDUCER, PRESSURE, CATHETER TIP1 recall29 reports
- TRUWAVE, VAMP PLUS PXVP2284AT3Edwards Lifesciences LLC · TRANSDUCER, PRESSURE, CATHETER TIP1 recall9 reports
- Comet H7493932430Boston Scientific Corporation · TRANSDUCER, PRESSURE, CATHETER TIP56 reports
- TruWave, VAMP T001744MEdwards Lifesciences LLC · Transducer, Pressure, Catheter Tip1 recall6 reports
- TRUWAVE PXMK2041Edwards Lifesciences LLC · TRANSDUCER, PRESSURE, CATHETER TIP1 recall4 reports
- TRUWAVE PX284Edwards Lifesciences LLC · TRANSDUCER, PRESSURE, CATHETER TIP1 recall3 reports
- TRUWAVE, VAMP PLUS PXVP23X3Edwards Lifesciences LLC · TRANSDUCER, PRESSURE, CATHETER TIP1 recall2 reports
- TRUWAVE, VAMP PLUS PXVP2260Edwards 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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