Browse Device Recalls

22 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 22 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 22 FDA device recalls.

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DateProductReasonClassFirm
Jan 19, 2022 SyncVision Systems, Model: 400-0100.10, PN: 30000485688x, with software versi... If FFR measurement(s) are made prior to an iFR/FFR co-registration/pullback in the same procedura... Class II Volcano Corporation
Nov 7, 2018 Philips Volcano FFR software used in the following systems connected to the M... Interoperability issue that affects certain systems that use the recalled software when it is con... Class II Volcano Corporation
Oct 17, 2018 Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 81234/400-0... Visions PV .035 Intravascular Ultrasound (IVUS) Catheters (catalog number 88901 adnd81234) due to... Class II Volcano Corporation
Oct 17, 2018 Visions PV .035 Digital IVUS Catheter, Catalog Number/Part Number 88901/400-0... Visions PV .035 Intravascular Ultrasound (IVUS) Catheters (catalog number 88901 adnd81234) due to... Class II Volcano Corporation
Mar 22, 2018 Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only. Used... The incorrect resistor has been used in affected CORE M2 Imaging Systems, which causes noise and ... Class II Volcano Corporation
Nov 3, 2017 Volcano Imaging System s5i REF 807400001; CORE Mobile Imaging System (120V) R... On certain Impacted Systems, an unexpected Microsoft Windows Security dialog may appear during us... Class II Volcano Corporation
Mar 29, 2017 Refinity Rotational Intravascular Ultrasound (IVUS) Catheter; Product number... High complaint rates of kinking near the junction of the proximal shaft to telescope section of t... Class II Volcano Corporation
Mar 29, 2017 Refinity Short Tip Rotational Intravascular Ultrasound (IVUS) Catheter; Prod... High complaint rates of kinking near the junction of the proximal shaft to telescope section of t... Class II Volcano Corporation
Apr 25, 2016 Volcano s5, s5i, CORE and CORE Mobile systems with software version 3.4 and v... Volcano has become aware of an incompatibility issue between Impacted Systems and hospital networ... Class II Volcano Corporation
Feb 5, 2016 Volcano SpinVision Sterile Equip cover II; Sterile; General Hospital: Thes... Volcano Corporation has identified that certain lot numbers of Volcano R-100 Sterile Equipment Co... Class II Volcano Corporation
Feb 5, 2016 Volcano R100 Sterile Equipment Cover; Sterile; General Hospital: These Ste... Volcano Corporation has identified that certain lot numbers of Volcano R-100 Sterile Equipment Co... Class II Volcano Corporation
Jul 22, 2015 Volcano Pioneer Plus Re-Entry Catheter; Product Code PPLUS20, Catheter for C... Due to a manufacturing defect, there is the possibility that a small wire could extend through th... Class II Volcano Corporation
Jun 22, 2015 Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 an... A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certa... Class II Volcano Corporation
Jun 22, 2015 Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 an... A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certa... Class II Volcano Corporation
Jun 22, 2015 Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 an... A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certa... Class II Volcano Corporation
Jun 22, 2015 Volcano s5/s5i/CORE Intravascular Ultrasound Systems with software versions 3... A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certa... Class II Volcano Corporation
Jun 22, 2015 Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 an... A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certa... Class II Volcano Corporation
Jun 22, 2015 Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 an... A software issue was discovered where an inaccurate FFR/iFR value could be calculated under certa... Class II Volcano Corporation
Jun 4, 2015 Volcano PV .035 Catheter: Part number: 88901; Product Usage: The Volcano... During a relabeling procedure at the manufacturing facility, the products were labeled with a she... Class II Volcano Corporation
Jun 4, 2015 Prestige Plus 185cm J-Tip: Part number: 9185J; Product Usage: The Presti... During a relabeling procedure at the manufacturing facility, the products were labeled with a she... Class II Volcano Corporation
Aug 13, 2014 Volcano TrakBack II Disposable Pullback Device; Sterile and nonpyrogenic; S... Internal testing had identified a potential breach to the sterile barrier that may impact the ste... Class II Volcano Corporation
Aug 24, 2012 Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Versio... The display on the system has the potential to change. In house testing eventually identified the... Class II Volcano Corporation

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.