Category

Cardiac Devices Recalls

958 cardiac devices recalls on record from CPSC, FDA, and USDA.

958 recalls
CriticalFDA
Boston Scientific Corporation
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 155 (5PKX3), REF H749085263022; cardiac catheter
Cardiac Devices·15,270 affected·Mar 21, 2024
CriticalFDA
Boston Scientific Corporation
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL2 (5PK), REF H74908526982; cardiac catheter
Cardiac Devices·8,715 affected·Mar 21, 2024
CriticalFDA
Boston Scientific Corporation
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085263012; cardiac catheter
Cardiac Devices·86,898 affected·Mar 21, 2024
High RiskFDA
Medtronic Perfusion Systems
Medtronic Left Heart Vent Catheters: a) DLP¿ Intracardiac Sump 20 Fr, Model Number 12012, b) DLP¿ Left Heart Vent Catheter 10 Fr., M...
Cardiac Devices·13,954 affected·Mar 19, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Non-sterile convenience kits: Medline Open Heart CDS, Pack #CDS981759C, containing a Pure Pouch with component Reorder #DYNJ04048, Kel...
Cardiac Devices·7,673 affected·Mar 14, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Sterile surgical convenience kits: a. Medline Cath Lab Special Procedure, Pack #00-RDF0360, containing a Pure Pouch with component M...
Cardiac Devices·12,588 affected·Mar 14, 2024
High RiskFDA
Medline Industries, Lp - Northfield
namic CONVENIENCE KIT, a) CAROTID MANIFOLD KIT, REF 60011045; b) 3V MANIFOLD KIT ON WITH NAMIC DT & WASTE MANAGEMENT, REF 60070582; ...
Cardiac Devices·570 affected·Mar 12, 2024
High RiskFDA
Biosense Webster, Inc.
CARTO VIZIGO Bi-Directional Guiding Sheath, REF D128502 The CARTO VIZIGOTM Bi-Directional Guiding Sheath is designed to provide acces...
Cardiac Devices·853 affected·Feb 16, 2024
High RiskFDA
Maquet Medical Systems Usa
BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with the CARDIOHELP heart-lung machine.
Cardiac Devices·16,520 affected·Jan 16, 2024
High RiskFDA
Maquet Medical Systems Usa
Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with the CARDIOHELP heart-lung machine.
Cardiac Devices·16,520 affected·Jan 16, 2024
CriticalFDA
Thoratec Corp.
1. HeartMate Touch Communication System, REF HMT1100 2. HeartMate Touch Communication System, Rental REF HMT1100-R 3. HeartMate Touch C...
Cardiac Devices·1,560 affected·Jan 3, 2024
High RiskFDA
Baxter Healthcare Corporation
XScribe CP Cardiac Stress Testing System, version 6, with below product names and codes: a) X-SCRIBE CPI KIT WIRELESS USB 608 MHz, 41000-...
Cardiac Devices·1,675 affected·Dec 8, 2023
High RiskFDA
Wavi Co.
WAVi Research EEG Desktop System is comprised of the WAVi Research EEG Desktop Software with Instruction Manual and Brochure, and Heart R...
Cardiac Devices·281 affected·Dec 8, 2023
High RiskFDA
Boston Scientific Corporation
Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 2892 Programmer Application Software us...
Cardiac Devices·14,328 affected·Nov 30, 2023
High RiskFDA
American Contract Systems, Inc.
Custom procedural convenience kits and trays, cardiac, labeled as: a) CENTRAL LINE INSERTION PACK, kit number LLCE52; b) Adult Centr...
Cardiac Devices·290 affected·Nov 29, 2023
High RiskFDA
Deroyal Industries Inc
DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572
Cardiac Devices·252 affected·Nov 22, 2023
High RiskFDA
Physio-control, Inc.
AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098
Cardiac Devices·18,732 affected·Nov 6, 2023
High RiskFDA
Maquet Medical Systems Usa
CARDIOHELP-i Heart Lung Support System- A blood oxygenation and carbon dioxide removal system used to pump blood through the extracorpore...
Cardiac Devices·1,595 affected·Nov 6, 2023
High RiskFDA
Medtronic Inc.
ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor
Cardiac Devices·64,739 affected·Nov 3, 2023
High RiskFDA
St. Jude Medical
CardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for wirelessly measuring and monitoring pulmonary artery press...
Cardiac Devices·36,153 affected·Oct 4, 2023
High RiskFDA
Maquet Cardiovascular, Llc
Maquet Acrobat-i Vacuum Stabilizer System Intended for use during performance of cardiac surgical procedures through a sternotomy incisio...
Cardiac Devices·2,951 affected·Sep 13, 2023
High RiskFDA
American Contract Systems, Inc.
Pediatric Heart SJH, REF SJPH34K
Cardiac Devices·72 affected·Sep 1, 2023
High RiskFDA
American Contract Systems, Inc.
Cath Cardiac Pack, REF IHCC03V
Cardiac Devices·1,260 affected·Sep 1, 2023
High RiskFDA
Boston Scientific Corporation
Guider Softip Guide Catheter 5F 100CM MULTI PURPOSE, Catalog number M003101630, cardiac guide catheter
Cardiac Devices·116 affected·Jul 27, 2023
High RiskFDA
Boston Scientific Corporation
Guider Softip Guide Catheter 8F 90CM MULTI PURPOSE, Catalog number H965100480, cardiac guide catheter
Cardiac Devices·17,436 affected·Jul 27, 2023
High RiskFDA
Boston Scientific Corporation
Guider Softip Guide Catheter 5F PRE-SHAPED 40 90CM, Catalog number M003100620, cardiac guide catheter
Cardiac Devices·1,086 affected·Jul 27, 2023
High RiskFDA
Boston Scientific Corporation
Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460, cardiac guide catheter
Cardiac Devices·2,245 affected·Jul 27, 2023
High RiskFDA
Boston Scientific Corporation
Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Cardiac Devices·4,990 affected·Jul 27, 2023
High RiskFDA
Boston Scientific Corporation
Guider Softip Guide Catheter 5F 90CM MULTI PURPOSE, Catalog number M003100630, cardiac guide catheter
Cardiac Devices·326 affected·Jul 27, 2023
High RiskFDA
Boston Scientific Corporation
Guider Softip Guide Catheter 7F 100CM MULTI PURPOSE, Catalog number M003101470, cardiac guide catheter
Cardiac Devices·828 affected·Jul 27, 2023
High RiskFDA
Boston Scientific Corporation
Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440, cardiac guide catheter
Cardiac Devices·8,475 affected·Jul 27, 2023
High RiskFDA
Boston Scientific Corporation
Guider Softip Guide Catheter 8F 100CM MULTI PURPOSE, Catalog number M003101480, cardiac guide catheter
Cardiac Devices·3,777 affected·Jul 27, 2023
High RiskFDA
Boston Scientific Corporation
Guider Softip Guide Catheter 8F PRE-SHAPED 40 100CM, Catalog number M003101440, cardiac guide catheter
Cardiac Devices·2,184 affected·Jul 27, 2023
High RiskFDA
Maquet Cardiovascular, Llc
ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000S. Component of a chest stabilization system for cardiac and chest surgery.
Cardiac Devices·401 affected·Jun 28, 2023
High RiskFDA
Maquet Cardiovascular, Llc
ACCESSRAIL Platform (Standard Blade) Part Number SB-1000, and (Deep Blades) Part Number C-DB-1000. Component of a chest stabilization sy...
Cardiac Devices·785 affected·Jun 28, 2023
High RiskFDA
Maquet Cardiovascular, Llc
ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-10000. Component of a chest stabilization system for cardiac and chest surgery.
Cardiac Devices·334 affected·Jun 28, 2023
High RiskFDA
Deroyal Industries Inc
Custom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF '53-1941; b) CARDIAC CATH PACK, REF '89-10045; c) SHOUL...
Cardiac Devices·4,225 affected·May 30, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a. NORTON CHILDRENS CATH LAB-LF, Model Number 00-...
Cardiac Devices·172,722 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY PACK, Model Number DYNJ55252C; b) ...
Cardiac Devices·3,740,814 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ANGIOGRAPHY DRP PK PEDI CATH, Model Number 00-4...
Cardiac Devices·55,014 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) EP PACER PACK, Model Number DYNJ67770A; b) EP ...
Cardiac Devices·3,740,814 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) MHC VASCULAR HYBRID PK-LF, Model Number DYNJ534...
Cardiac Devices·3,740,814 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PEDIATRIC CATH ANGIO PA...
Cardiac Devices·233,638 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CRMC MINOR IR PROCEDURE...
Cardiac Devices·76,870 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. AAA PACK, Model Number:...
Cardiac Devices·46,124 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. OPEN HEART CDS-LF, Mode...
Cardiac Devices·43,149 affected·May 15, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. (13) STC IVC FILTER/ANG...
Cardiac Devices·97,677 affected·May 15, 2023
High RiskFDA
Remote Diagnostic Technologies Ltd.
Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020
Cardiac Devices·1,147 affected·May 8, 2023