UVAR XTS XT001Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20705030200010), received between Jan 5, 2017 and Apr 11, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (2 reports).

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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 11, 2018Break; Fluid/Blood Leak

  THE CUSTOMER SENT AN EMAIL TO REPORT A CENTRIFUGE BOWL LEAK/BREAK DURING THE TREATMENT PROCEDURE. THE CUSTOMER REPORTED A LEAK CENTRIFUGE ALARM WAS RECEIVED AND A LEAK WAS OBSERVED. THE LOCATION OF THE LEAK WAS NOT PROVIDED. THE CUSTOMER ABORTED THE PROCEDURE AND DID NOT RETURN BLOOD TO THE PATIENT. THE CUSTOMER REPORTED THE PATIENT WAS STABLE. THE CUSTOMER HAS RETURNED PHOTOGRAPHS FOR INVESTIGATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7422571 ↗
• MalfunctionSep 5, 2017Leak/Splash; Device Displays Incorrect Message

  CUSTOMER CALLED TO REPORT THAT HALFWAY THROUGH PHOTO ACTIVATION AN EMPTY A/C ALARM SOUNDED AND THAT IS WHEN A LEAK IN THE TUBING WAS OBSERVED. THE LEAK WAS REPORTED TO BE IN THE LINE WHERE THE HEMATOCRIT SENSOR IS PLACED. THE PROCEDURE WAS ABORTED AND NO FLUIDS WERE RETURNED TO THE PATIENT. THERE WILL BE NO PRODUCT RETURNED FOR INVESTIGATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6841795 ↗
• MalfunctionJan 5, 2017Leak/Splash; Device Displays Incorrect Message; Inadequate User Interface

  THE CUSTOMER CALLED TO REPORT OCCLUSION SYSTEM ALARMS ( X3) THAT OCCURRED DURING THE FIRST BUFFY COAT COLLECTION. THE CUSTOMER STATED THAT THEY CHECKED THE KIT FOR ANY KINKS OR CLOTS, BUT DID NOT NOTE ANY ABNORMALITIES. THE CUSTOMER WAS ASKED TO REMOVE THE CENTRIFUGE BOWL IN ORDER TO INSPECT THE CENTRIFUGE BOWL FOR CLOTS. THE CUSTOMER REPORTED THAT HE ATTEMPTED TO REMOVE THE CENTRIFUGE BOWL WITHOUT STOPPING THE CENTRIFUGE FIRST. THE CUSTOMER STATED THAT HE WAS UNABLE TO REMOVE THE CENTRIFUGE BOWL AND NOW HE HAD "BLOOD ON HIS HANDS". THE CUSTOMER REPORTED THAT THERE WAS NO LEAK ALARM. THE CUSTOMER STATED THAT THE TREATMENT WAS ABORTED WITH NO BLOOD/PRODUCTS RETURNED TO THE PATIENT. THE CUSTOMER REPORTED THAT THE PATIENT WAS IN STABLE CONDITION AND WAS STARTED ON ANOTHER TREATMENT. THE CUSTOMER STATED THAT THERE WAS A SMALL BLOOD LEAK AT THE TOP OF THE BOWL AFTER HE ATTEMPTED TO REMOVE THE BOWL WITHOUT STOPPING THE CENTRIFUGE. THE CUSTOMER REPORTED THAT HE WAS WEARING GLOVES AT THE TIME THUS THERE WAS NO BLOOD EXPOSURE. THE CUSTOMER STATED THAT HE DID NOTE AN ALARM ON THE INSTRUMENT'S DISPLAY AND THE CENTRIFUGE HAD STOPPED WHEN HE OPENED THE CENTRIFUGE LID. THE CUSTOMER REPORTED THAT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6227675 ↗