Q50 Plus Q50-65PRecalls & reported problems
Qxmedical · Q50 Plus Stent Graft Balloon Catheter, 65cm · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00853892004003), received between Aug 14, 2017 and Aug 14, 2017 — classified as 1 death.
The most frequently reported specific device problem is “Leak/Splash” (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 16, 2026.
Most reported problems
Device problems
- Leak/Splash1
Patient problems
- Death1
- Hemorrhage/Blood Loss/Bleeding1
- Rupture1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathAug 14, 2017Leak/Splash
ON (B)(6) 2017, THE PATIENT UNDERWENT TREATMENT OF A SYMPTOMATIC CONTAINED RUPTURE USING GORE® EXCLUDER® AAA ENDOPROSTHESES. IT WAS REPORTED THE PATIENT PRESENTED WITH ABDOMINAL PAIN, BUT OTHERWISE HAD A STABLE BLOOD PRESSURE AND HEART RATE. THE PATIENT WAS REPORTED TO HAVE A REVERSE TAPER IN THE PROXIMAL NECK WITH CONSECUTIVE DIAMETERS OF 27 MM, 31 MM, AND 21 MM OVER A 3 CM SEGMENT. IT WAS ALSO REPORTED THE PATIENT'S PROXIMAL NECK MEASURED GREATER THAN 90° IN ANGULATION. ON (B)(6) 2017, THE PATIENT UNDERWENT TREATMENT OF A SYMPTOMATIC CONTAINED RUPTURE USING GORE® EXCLUDER® AAA ENDOPROSTHESES. IT WAS REPORTED THE PATIENT PRESENTED WITH ABDOMINAL PAIN, BUT OTHERWISE HAD A STABLE BLOOD PRESSURE AND HEART RATE. THE PATIENT WAS REPORTED TO HAVE A REVERSE TAPER IN THE PROXIMAL NECK WITH CONSECUTIVE DIAMETERS OF 27 MM, 31 MM, AND 21 MM OVER A 3 CM SEGMENT. IT WAS ALSO REPORTED THE PATIENT'S PROXIMAL NECK MEASURED GREATER THAN 90° IN ANGULATION. IT WAS REPORTED THAT AFTER A TRUNK-IPSILATERAL LEG COMPONENT (RLT351414/16422464) AND CONTRALATERAL LEG COMPONENT (PXC121000/16080303)WERE IMPLANTED AND ONE POST-IMPLANT DILATION BALLOONING USING A CODA BALLOON WAS PERFORMED, INTRAOPERATIVE IMAGI
Patient problems: Death; Hemorrhage/Blood Loss/Bleeding; Rupture
MAUDE report 6791670 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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