Category

Cardiac Devices Recalls

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

958 recalls
High RiskFDA
Merit Medical Systems, Inc.
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: K12T/12PI (Custom Pr...
Cardiac Devices·34,197 affected·Jun 11, 2024
High RiskFDA
Baxter Healthcare Corporation
Welch Allyn CP150 Electrocardiograph with Spirometry Option, Product Code: CP150A-1ENB. The Electrocardiograph is one of the tools that c...
Cardiac Devices·1 affected·Jun 3, 2024
CriticalFDA
Abiomed, Inc.
Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
Cardiac Devices·9 affected·May 31, 2024
High RiskFDA
Cardinal Health 200, Llc
Presource kits and trays, labeled as: 1) Cardiovascular Procedure Kit, Catalog Number SAN29ANCC3; 2) Cardiovascular Procedure Kit, Cat...
Cardiac Devices·17,445 affected·May 29, 2024
High RiskFDA
Artivion, Inc
(1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellularized Cardiac Tissue Allograft Prepare...
Cardiac Devices·2 affected·May 28, 2024
High RiskFDA
Remote Diagnostic Technologies Ltd.
Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual
Cardiac Devices·1,745 affected·May 9, 2024
High RiskFDA
Philips Medical Systems Nederland B.v.
Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascu...
Cardiac Devices·391 affected·May 2, 2024
High RiskFDA
Nihon Kohden America Inc
BSM-3000 Series Bedside Monitor REF BSM-3572A The Life Scope BSM-3000 Series Bedside Monitoring System is intended to monitor, display...
Cardiac Devices·16 affected·Apr 29, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits labeled as: 1) KIT MANIFOLD CSTM-NORTHRIDGE, Pack Number 129736 ; 2) KIT LEFT HEART-VA MED, Pack Number 132...
Cardiac Devices·0 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline procedural kits labeled as: 1) OPEN HEART PEDS, Pack Number CDS981050Q; 2) OPEN HEART CDS, Pack Number CDS982411N; 3) OPEN...
Cardiac Devices·0 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Centurion procedure kits labeled as: 1) 3" RADIAL ARTERIAL LINE KIT- ICU, Pack Number ART240B; 2) 5FR 2L PICC LINE TRAY, Pack Number P...
Cardiac Devices·0 affected·Apr 8, 2024
High RiskFDA
Heartsine Technologies Ltd
HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P
Cardiac Devices·183,248 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits labeled as: 1) EP DRAPE PACK-LF, Pack Number DYNJ0209716K ; 2) MERCY COMBINED PACK-LF, Pack Number DYNJ0233...
Cardiac Devices·0 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline procedural kits labeled as: 1) DRAWER 3 LAB DRAW & IV START, Pack Number ACC010417 ; 2) DRAWER 3 LAB DRAW & IV START, Pack N...
Cardiac Devices·0 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits labeled as: 1) CATH LAB SPECIAL PROCEDURE, Pack Number 00-RDF036O; 2) CATH LAB SPECIAL PROCEDURE, Pack Number...
Cardiac Devices·0 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline Convenience kits labeled as: 1) MYELOGRAM PACK, Pack Number 00-399025L ; 2) BIOPSY PROCEDURE PACK , Pack Number 00-399227G ; ...
Cardiac Devices·0 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline convenience kits labeled as: 1) PERMANENT PACING, Pack Number 00-400361J ; 2) NORTON CHILDRENS CATH LAB-LF, Pack Number 00-401...
Cardiac Devices·0 affected·Apr 8, 2024
High RiskFDA
Medline Industries, Lp - Northfield
Medline medical procedure kits labeled as follows: a) HEART ANESTHESIA SET UP, REF DYNJ902752C, b) KIT ENDO, REF DYKE1872A, c) LOW...
Cardiac Devices·26,096 affected·Mar 22, 2024
CriticalFDA
Boston Scientific Corporation
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (5PKX3), REF H749085263002; cardiac catheter
Cardiac Devices·46,860 affected·Mar 21, 2024
CriticalFDA
Boston Scientific Corporation
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR6 (5PK), REF H74908526042; cardiac catheter
Cardiac Devices·290 affected·Mar 21, 2024
CriticalFDA
Boston Scientific Corporation
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR1 (5PK), REF H74908526842; cardiac catheter
Cardiac Devices·11,109 affected·Mar 21, 2024
CriticalFDA
Boston Scientific Corporation
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 (5PK), REF H74908526022; cardiac catheter
Cardiac Devices·297,479 affected·Mar 21, 2024
CriticalFDA
Boston Scientific Corporation
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM (5PK), REF H749085262012; cardiac catheter
Cardiac Devices·25,617 affected·Mar 21, 2024
CriticalFDA
Boston Scientific Corporation
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 125CM (5PK), REF H749085262352; cardiac catheter
Cardiac Devices·15 affected·Mar 21, 2024
CriticalFDA
Boston Scientific Corporation
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 (5PK), REF H74908526222; cardiac catheter
Cardiac Devices·116,091 affected·Mar 21, 2024
CriticalFDA
Boston Scientific Corporation
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085265022; cardiac catheter
Cardiac Devices·1,950 affected·Mar 21, 2024
CriticalFDA
Boston Scientific Corporation
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WRP (5PK), REF H74908526512; cardiac catheter
Cardiac Devices·8,575 affected·Mar 21, 2024
CriticalFDA
Boston Scientific Corporation
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (SGL), REF H74908526031; cardiac catheter
Cardiac Devices·0 affected·Mar 21, 2024
CriticalFDA
Boston Scientific Corporation
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS4 (5PK), REF H74908526575A2; cardiac catheter
Cardiac Devices·95 affected·Mar 21, 2024
CriticalFDA
Boston Scientific Corporation
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 MOD (5PK), REF H74908526052; cardiac catheter
Cardiac Devices·385 affected·Mar 21, 2024
CriticalFDA
Boston Scientific Corporation
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (SGL), REF H749085263011; cardiac catheter
Cardiac Devices·847 affected·Mar 21, 2024
CriticalFDA
Boston Scientific Corporation
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085265002; cardiac catheter
Cardiac Devices·105 affected·Mar 21, 2024
CriticalFDA
Boston Scientific Corporation
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 (5PK), REF H7490852624; cardiac catheter
Cardiac Devices·8,579 affected·Mar 21, 2024
CriticalFDA
Boston Scientific Corporation
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL3 (5PK), REF H749085261002; cardiac catheter
Cardiac Devices·1,465 affected·Mar 21, 2024
CriticalFDA
Boston Scientific Corporation
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3 (5PK)REF H7490852620A2; cardiac catheter
Cardiac Devices·8,725 affected·Mar 21, 2024
CriticalFDA
Boston Scientific Corporation
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR2 (5PK), REF H74908526862; cardiac catheter
Cardiac Devices·9,271 affected·Mar 21, 2024
CriticalFDA
Boston Scientific Corporation
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR MOD (5PK), REF H74908526892; cardiac catheter
Cardiac Devices·4,942 affected·Mar 21, 2024
CriticalFDA
Boston Scientific Corporation
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AL1 (5PK), REF H74908526962; cardiac catheter
Cardiac Devices·37,252 affected·Mar 21, 2024
CriticalFDA
Boston Scientific Corporation
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3.5 (5PK), REF H74908526574A2; cardiac catheter
Cardiac Devices·615 affected·Mar 21, 2024
CriticalFDA
Boston Scientific Corporation
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS2.5 (5PK), REF H74908526572A2; cardiac catheter
Cardiac Devices·440 affected·Mar 21, 2024
CriticalFDA
Boston Scientific Corporation
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO TIG4 (5PK), REF H749085262502; cardiac catheter
Cardiac Devices·4,270 affected·Mar 21, 2024
CriticalFDA
Boston Scientific Corporation
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK (SGL), REF H749085263001; cardiac catheter
Cardiac Devices·363 affected·Mar 21, 2024
CriticalFDA
Boston Scientific Corporation
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4.5 (5PK), REF H74908526232; cardiac catheter
Cardiac Devices·4,715 affected·Mar 21, 2024
CriticalFDA
Boston Scientific Corporation
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO KIMNY (5PK), REF H749085261802; cardiac catheter
Cardiac Devices·230 affected·Mar 21, 2024
CriticalFDA
Boston Scientific Corporation
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO LCB (5PK), REF H749085261952; cardiac catheter
Cardiac Devices·5,510 affected·Mar 21, 2024
CriticalFDA
Boston Scientific Corporation
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMT (5PK), REF H749085262022; cardiac catheter
Cardiac Devices·2,366 affected·Mar 21, 2024
CriticalFDA
Boston Scientific Corporation
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR4 125CM (5PK), REF H749085262252; cardiac catheter
Cardiac Devices·5,435 affected·Mar 21, 2024
CriticalFDA
Boston Scientific Corporation
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 (5PK), REF H74908526032; cardiac catheter
Cardiac Devices·15,079 affected·Mar 21, 2024