Catheter, Ultrasound, Intravascular

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2026-06-13Open, ClassifiedNonconforming Material/Component

  Description/REF: PI JACC KIT: 2L 5.5 FR X 15 CM CG+/ASK-41552-LTAC; PI JACC KIT: 3L 6 FR X 20 CM CG+/ASK-42063-LTAC; AGBA PI JACC KIT: 1-L 4.5 FR X 15 CM/CDC-41541-JX1A; AGBA PI JACC KIT: 2-L 5.5 FR X 15 CM/CDC-41552-JX1A; AGBA PI JACC KIT: 3-L 6 FR X 15 CM/CDC-41563-JX1A; AGBA PI JACC KIT: 1-L 4.5 FR X 20 CM/CDC-42041-JX1A; AGBA PI JACC KIT: 2-L 5.5 FR X 20 CM/CDC-42052-JX1A; AGBA PI JACC KIT: 3-L 6 FR X 20 CM/CDC-42063-JX1A

  Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

• 2025-07-30Open, Classified

  Volcano Visions Digital IVUS Catheter: PV.014P (Platinum), REF:85910P; PV.014P RX, REF: 014R; and PV.018, REF: 86700, 86700J used with Instructions for use.

  Reports of IVUS catheter and guide wire entanglement during radial-to-peripheral procedures, due to catheter use without appropriate sheath and/or guide catheter, which may require further intervention, such as surgical removal; Firm is restating instructions for use and adding: "Use a guide sheath of appropriate length to provide adequate support to the rapid exchange IVUS catheter and guidewire"

• 2025-04-23Open, ClassifiedProcess control

  Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product Description: Common Name: Diagnostic intravascular catheter Description: The Novasight Hybrid catheter is a 3Fr single use, sterile device, which will be able to perform transluminal ultrasound and optical coherence tomography imaging of adults. The catheter is capable of real-time 2D side viewing ultrasound and optical imaging acquired simultaneously providing precisely co-registered images with the ability to produce rapidly post processed rendered longitudinal images of the vessel. Packaging: The Novasight Hybrid Catheter is packaged in a packaging system including the protective packaging and the sterile barrier system.

  Due to manufacturing issues there is a potential for the catheter sheath to detach.

• 2024-03-28Open, ClassifiedProcess control

  OptiCross Coronary Imaging Catheter, REF H749518080120

  Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage setting, which may have resulted in decreased image brightness.

• 2021-03-04TerminatedDevice Design

  ACIST Kodama Intravascular Ultrasound Catheter The Kodama Intravascular Ultrasound Catheter is a component of the ACIST HDi System. The ACIST HDi System is intended to be used for ultrasound examination of coronary and peripheral intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. The ACIST Kodama Intravascular Ultrasound Catheter is intended for use with the ACIST HDi System.

  Test results from the manufacturing line found a piece of damaged o-ring in an unexpected section of the catheter. Further testing indicated that pieces (>200 micron) of damaged o-ring had the potential to be flushed out of the catheter. ACIST is confirming the source of the failure mode to assure the quality and reliability of the Kodama catheter. There have been no related field reports related to this incident, nor any evidence or report of patient injury or adverse health consequence.

• 2017-04-10TerminatedUnder Investigation by firm

  Refinity Rotational Intravascular Ultrasound (IVUS) Catheter; Product number: 400-0200.289; Catalog number 89800. Cardiovascular: The REFINITY (or REFINITY ST) Rotational IVUS Catheter (REFINITY or REFINITY ST) is intended for the intravascular ultrasound examination of coronary arteries. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. REFINITY (or REFINITY ST) catheters are designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.

  High complaint rates of kinking near the junction of the proximal shaft to telescope section of the catheter. Kinking could result in disruption of normal clinical workflow or loss of imaging.

• 2017-04-10TerminatedUnder Investigation by firm

  Refinity Short Tip Rotational Intravascular Ultrasound (IVUS) Catheter; Product number: 400-0200.273; Catalog number 89900. Cardiovascular: The REFINITY (or REFINITY ST) Rotational IVUS Catheter (REFINITY or REFINITY ST) is intended for the intravascular ultrasound examination of coronary arteries. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures. REFINITY (or REFINITY ST) catheters are designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.

  High complaint rates of kinking near the junction of the proximal shaft to telescope section of the catheter. Kinking could result in disruption of normal clinical workflow or loss of imaging.

• 2015-10-01TerminatedDevice Design

  SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. For intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart.

  Image disappeared from the cardiac ultrasound system when the CARTO 3 EP Navigation System needed restarting while the patient was experiencing pericardial effusion. Affects the CARTOSOUND Module of the CARTO 3 EP Navigation System when used with the SOUNDSTAR eco 8F and 10F Diagnostic Ultrasound Catheters. New precautions added.

• 2015-08-31TerminatedUnder Investigation by firm

  Arrow International, Inc. PICC Kits and VPS Access Kits with Touhy Borst Component Catheter, Intravascular, Therapeutic, Ultrasound, Long Term Greater than 30 Days

  saline leakage from unsecured connections between the Touhy Borst adaptor and the hub of the catheter. No injuries reported.

• 2015-06-25TerminatedLabeling mix-ups

  Volcano PV .035 Catheter: Part number: 88901; Product Usage: The Volcano PV .035 is indicated for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by providing a cross-sectional image of such vessels. The device is an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures and dimensional measurements from the image.

  During a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in accordance with the date of the relabeling and not in accordance with the original shelf life date at the time of manufacture