N/A (REF D087031)Recalls & reported problems
Innovative Health LLC · ViewFlex Xtra ICE Diagnostic Ultrasound Catheter 90 cm 9F · Class 2
Quick summary
This is a reprocessed ViewFlex Xtra intravascular ultrasound catheter, a tube used inside the heart to take ultrasound images from inside the blood vessels. Most of the 37 reports describe the catheter tip cracking or breaking, sometimes as it was inserted into or pulled from its sheath, along with blurry or grainy images and bent shafts. One report mentions a perforation of the heart lining, and there was 1 injury and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 37
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10841898123252), received between Mar 17, 2021 and Apr 7, 2026 — classified as 1 injury, 36 malfunctions.
The most frequently reported specific device problem is “Fracture” (34 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.
Reports received per month
Most reported problems
Device problems
- Fracture34
- Poor Quality Image5
- No Display/Image4
- Material Twisted/Bent2
- Fluid/Blood Leak1
- Positioning Failure1
Patient problems
- No Clinical Signs, Symptoms or Conditions35
- Cardiac Perforation2
Recent adverse event reports
The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 7, 2026Fracture; Poor Quality Image
THE DEVICE WAS ORIGINALLY REPORTED TO HAVE BAD IMAGES ON ICE CATHETER. VIEWS WERE BLURRY. UPON DEVICE RECEIPT AND INSPECTION, THE DEVICE WAS NOTED TO HAVE A FRACTURE IN THE DISTAL TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24810651 ↗MalfunctionAug 27, 2025Poor Quality Image; Poor Quality Image
A REPROCESSED VIEWFLEX DEVICE WAS REPORTED TO HAVE BEEN USED DURING A PROCEDURE WHERE A PERFORATION OCCURRED RESULTING IN A PERICARDIAL EFFUSION. IT WAS REPORTED THAT A BRK TRANSSEPTAL NEEDLE FROM A DIFFERENT MANUFACTURER WAS ALSO IN USE AT THE TIME OF THE EVENT.
Patient problems: Cardiac Perforation
MAUDE report 22904928 ↗MalfunctionAug 7, 2025Fracture; Poor Quality Image; Fracture; Poor Quality Image
THE DEVICES WAS REPORTED TO HAVE BEEN RECEIVED DAMAGED AND NON-FUNCTIONING. TWO IMAGES WERE PROVIDED OF THE DEVICE, ONE WITH A FRACTURE AND ONE WITH CONSOLE TRANSDUCER DIAGNOSTICS DISPLAYED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22743423 ↗MalfunctionJun 2, 2025Fracture; Fracture
THE DEVICE WAS REPORTED TO HAVE A TIP FRACTURE. THE TIP FRACTURE OCCURRED DURING THE PROCEDURE UPON EXIT FROM THE SHEATH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22126722 ↗MalfunctionMay 23, 2024Material Twisted/Bent; Material Twisted/Bent
THE DEVICE WAS REPORTED TO BE BENT. THE FAILURE WAS REPORTED TO HAVE OCCURRRED AT INSERTION OF THE DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19382659 ↗MalfunctionDec 18, 2023Fracture; Fluid/Blood Leak; Fracture
THIS DEVICE WAS REPORTED TO HAVE THE TIP OF THE DEVICE BREAK DURING INSERTION INTO THE SHEATH. NO PATIENT INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18344973 ↗MalfunctionMay 16, 2023Fracture; Poor Quality Image; Fracture; Poor Quality Image
THE DEVICE WAS REPORTED TO HAVE POOR IMAGE QUALITY DURING A PROCEDURE. THE DEVICE WAS REPORTED TO BE BENT AND HAVE A CRACK IN THE TIP. NO INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16942750 ↗MalfunctionMay 16, 2023Fracture; Poor Quality Image; Fracture; Poor Quality Image
THE DEVICE WAS REPORTED TO HAVE A GRAINY IMAGE DURING A PROCEDURE. THE CATHETER TIP WAS ALSO REPORTED TO BE BENT. NO PATIENT INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16942683 ↗MalfunctionApr 25, 2023No Display/Image; Fracture; No Display/Image; Fracture
THE DEVICE WAS REPORTED TO HAVE A BENT TIP AND NO SIGNAL. NO PATIENT INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16808934 ↗MalfunctionApr 25, 2023No Display/Image; Fracture; No Display/Image; Fracture
THE DEVICE WAS REPORTED TO HAVE A BENT TIP AND NO SIGNAL. NO PATIENT INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16808926 ↗MalfunctionMar 31, 2023Fracture; Fracture
THE TIP OF THIS DEVICE WAS REPORTED TO BE PARTIALLY BROKEN WHEN VISUALIZED WITH FLUORO AS THE DEVICE WAS INSERTED INTO THE BODY. THE DEVICE WAS IMMEDIATELY REMOVED FROM THE BODY. NO PATIENT INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16657256 ↗MalfunctionNov 19, 2022No Display/Image; Fracture; No Display/Image; Fracture
THIS DEVICE WAS REPORTED TO HAVE ITS IMAGE GO BLACK JUST BEFORE GOING TRANSSEPTAL. ANOTHER DEVICE WAS ABLE TO BE USED WITHOUT ISSUE. INVESTIGATION OF THE RETURNED DEVICE IDENTIFIED A FRACTURED TIP AND A KINK ON THE SHAFT. NO PATIENT INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15831015 ↗MalfunctionNov 14, 2022Positioning Failure; No Display/Image; Fracture; Positioning Failure; No Display/Image; Fracture
THIS DEVICE WAS REPORTED AS NOT BEING ABLE TO STEER, AND THE IMAGE WENT BLACK DURING THE PROCEDURE. INVESTIGATION OF THE RETURNED DEVICE IDENTIFIED A FRACTURED TIP. NO PATIENT INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15789253 ↗MalfunctionSep 14, 2022Fracture; Fracture
THE TIP OF THIS DEVICE WAS REPORTED TO HAVE FRACTURED DURING THE PROCEDURE. NO PATIENT INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15422577 ↗MalfunctionAug 11, 2022Fracture; Fracture
THE TIP OF THIS DEVICE WAS REPORTED TO HAVE FRACTURED DURING THE PROCEDURE. NO PATIENT INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15210534 ↗MalfunctionJun 29, 2022Fracture; Fracture
THE TIP OF THIS DEVICE WAS REPORTED TO HAVE FRACTURED DURING THE PROCEDURE. NO PATIENT INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14861845 ↗MalfunctionMay 25, 2022Material Twisted/Bent; Material Twisted/Bent
THE DISTAL SHAFT OF THIS DEVICE WAS REPORTED TO HAVE BENT WHILE INSIDE THE PATIENT. NO PATIENT INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14500507 ↗MalfunctionApr 6, 2022Fracture; Fracture
THE TIP OF THIS DEVICE WAS REPORTED TO HAVE BROKEN. NO PATIENT INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14033298 ↗MalfunctionMar 15, 2022Fracture; Fracture
THE TIP OF THIS DEVICE WAS REPORTED TO HAVE BROKEN WHILE INSIDE THE PATIENT. NO PATIENT INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13772079 ↗MalfunctionMar 8, 2022Fracture; Fracture
THE TIP OF THIS DEVICE WAS REPORTED TO HAVE BROKEN WHILE INSIDE THE PATIENT. NO PATIENT INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13694787 ↗MalfunctionMar 8, 2022Fracture; Fracture
TWO DEVICES WERE REPORTED THAT WERE INVOLVED IN TWO SEPARATE CASES. INFORMATION REGARDING WHICH DEVICE BELONGS TO WHICH EVENT WAS NOT PROVIDED. THE FIRST DEVICE WAS REPORTED TO HAVE ITS TIP BREAK WHILE INSIDE THE PATIENT. IT DID NOT BREAK OFF COMPLETELY AND THE DOCTOR WAS ABLE TO RETRIEVE THE ENTIRE CATHETER WITHOUT ANY EXTRA INTERVENTION. NO INJURIES WERE REPORTED. THE SECOND DEVICE WAS REPORTED TO HAVE ITS TIP BREAK UPON INSERTION. NO INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13694603 ↗MalfunctionMar 8, 2022Fracture; Fracture
TWO DEVICES WERE REPORTED THAT WERE INVOLVED IN TWO SEPARATE CASES. INFORMATION REGARDING WHICH DEVICE BELONGS TO WHICH EVENT WAS NOT PROVIDED. THE FIRST DEVICE WAS REPORTED TO HAVE ITS TIP BREAK WHILE INSIDE THE PATIENT. IT DID NOT BREAK OFF COMPLETELY AND THE DOCTOR WAS ABLE TO RETRIEVE THE ENTIRE CATHETER WITHOUT ANY EXTRA INTERVENTION. NO INJURIES WERE REPORTED. THE SECOND DEVICE WAS REPORTED TO HAVE ITS TIP BREAK UPON INSERTION. NO INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13694537 ↗MalfunctionNov 8, 2021Fracture; Fracture
THE TIP OF THIS DEVICE WAS REPORTEDLY KINKED WHILE ADVANCING IT INTO THE HEART FROM VEIN ACCESS. NO PATIENT INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12776098 ↗MalfunctionOct 26, 2021Fracture; Fracture
THE TIP OF THIS DEVICE WAS REPORTED TO BE BROKEN DURING THE PROCEDURE. NO PATIENT INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12700995 ↗MalfunctionOct 26, 2021Fracture; Fracture
THE TIP OF THIS DEVICE WAS REPORTED TO BE BENT. NO PATIENT INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12700964 ↗
Other Reprocessed Intravascular Ultrasound Catheter devices
- MEDLINE D087031RHMedline Industries, Inc. · Reprocessed intravascular ultrasound catheter2 recalls5 reports
- MEDLINE 10135910RHMedline Industries, Inc. · Reprocessed intravascular ultrasound catheter2 recalls0 reports
- MEDLINE 10135936RHMedline Industries, Inc. · Reprocessed intravascular ultrasound catheter2 recalls0 reports
- NA ACU10135936Sterilmed, Inc. · Reprocessed intravascular ultrasound catheter1 recall11 reports
- NA ACU10135910Sterilmed, Inc. · Reprocessed intravascular ultrasound catheter1 recall6 reports
- MEDLINE 10438577RHMedline Industries, Inc. · Reprocessed intravascular ultrasound catheter1 recall0 reports
- MEDLINE 10439236RHMedline Industries, Inc. · Reprocessed intravascular ultrasound catheter1 recall0 reports
- MEDLINE 10439011RHMedline Industries, Inc. · Reprocessed intravascular ultrasound catheter1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.