Category

Cardiac Devices Recalls

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

958 recalls
High RiskFDA
Abbott Vascular
Product/Part: MitraClip XTR Clip Delivery System US/CDS0601-XTR, MitraClip G4 Clip Delivery System NT US/CDS0701-NT, MitraClip G4 Clip ...
Cardiac Devices·18,042 affected·Sep 8, 2022
High RiskFDA
Johnson & Johnson Surgical Vision, Inc.
THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S. Used for catheter-based cardiac electrophysiological mapp...
Cardiac Devices·91 affected·Sep 7, 2022
RecallFDA
Siemens Medical Solutions Usa, Inc
AXIOM Sensis or Sensis Vibe Combo systems as follows: System Material # AXIOM Sensis, Combo 64 6623974; ...
Cardiac Devices·399 affected·Jul 12, 2022
CriticalFDA
Heartware, Inc.
HeartWare Ventricular Assist Device (HVAD) System Batteries, Product Number 1650DE
Cardiac Devices·19,616 affected·Jun 28, 2022
High RiskFDA
American Contract Systems, Inc.
Various Pacemaker Packs, Cardio Thoracic Packs
Cardiac Devices·24 affected·Jun 16, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
Sensis with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiolo...
Cardiac Devices·2 affected·Jun 15, 2022
High RiskFDA
Medline Industries, Lp - Spt
Medline Convenience kits labeled as follows: a. BEDSIDE PICC CDS, Model Number CDS984642, b. VASCULAR CDS, Model Number DYNJ902880J, c. ...
Cardiac Devices·1,960 affected·Jun 6, 2022
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension LTNI -In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma...
Cardiac Devices·76 affected·May 18, 2022
High RiskFDA
Siemens Healthcare Diagnostics, Inc.
Dimension CTNI-In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels in human serum and heparinized plasma ...
Cardiac Devices·113 affected·May 18, 2022
CriticalFDA
Medtronic Inc
HeartWare Battery, Model #1650DE, a component of the HeartWare Ventricular Assist Device (HVAD) System.
Cardiac Devices·429 affected·May 5, 2022
High RiskFDA
Heartware, Inc.
HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit
Cardiac Devices·667 affected·Mar 30, 2022
High RiskFDA
Heartware, Inc.
HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH
Cardiac Devices·0 affected·Mar 30, 2022
High RiskFDA
Heartware, Inc.
HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420
Cardiac Devices·510 affected·Mar 30, 2022
High RiskFDA
Heartware, Inc.
HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0
Cardiac Devices·59 affected·Mar 30, 2022
High RiskFDA
Heartware, Inc.
HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ Sys...
Cardiac Devices·645 affected·Mar 30, 2022
High RiskFDA
Philips North America Llc
Philips, REF M5071A, Adult. Smart PADS CARTRIDGE, 8+ years FOR USE WITH HEARSTART HS1 DEFIBRILLATORS
Cardiac Devices·1,696,047 affected·Feb 4, 2022
High RiskFDA
Philips North America Llc
Philips, REF M5072A, INFANT/CHILD - SMART PADS CARTRIDGE (0-8 YEARS). Smart PADS CARTRIDGE , (0-8 YEARS) <55 lbs/25 kg, CE 0123, NON-STER...
Cardiac Devices·331,712 affected·Feb 4, 2022
RecallFDA
Physio-control, Inc.
HeartSine Samaritan PAD, SAM 350P Semi-Automatic Defibrillator, used with Pad-Pak
Cardiac Devices·1 affected·Jan 13, 2022
High RiskFDA
Siemens Medical Solutions Usa, Inc
1. Sensis, material # 10764561; UDI: 04056869010137 2. Sensis Vibe Hemo, material # 11007641; UDI: 04056869010199 3. Sensis Vibe Combo,...
Cardiac Devices·1,047 affected·Nov 23, 2021
High RiskFDA
Thoratec Corp.
Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU)
Cardiac Devices·988 affected·Oct 22, 2021
High RiskFDA
Medtronic Perfusion Systems
DLP Left Heart Vent Catheters, 18 FR. Sterile, Rx Only
Cardiac Devices·48,672 affected·Aug 24, 2021
High RiskFDA
Medtronic Perfusion Systems
DLP Left Heart Vent Catheters, 16 FR. Sterile, Rx Only
Cardiac Devices·51,494 affected·Aug 24, 2021
CriticalFDA
Philips North America Llc
The Azurion series (within the limits of the used Operation Room table) are intended for use to perform: "Image guidance in diagnostic, ...
Cardiac Devices·1 affected·Aug 13, 2021
RecallFDA
Sentinel Ch Spa
Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the Alinity c CRP Va...
Cardiac Devices·32 affected·Jul 29, 2021
High RiskFDA
Ge Healthcare, Llc
The system is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at diffe...
Cardiac Devices·0 affected·Jun 30, 2021
High RiskFDA
Merit Medical Systems, Inc.
Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, (01) 008844504...
Cardiac Devices·760 affected·Jun 30, 2021
High RiskFDA
Boston Scientific Corporation
Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331
Cardiac Devices·70,074 affected·Jun 3, 2021
CriticalFDA
Heartware, Inc.
HeartWare HVAD Outflow Graft, REF MCS1725OG
Cardiac Devices·459 affected·Jun 3, 2021
CriticalFDA
Heartware, Inc.
HeartWare HVAD Pump Accessories, REF MCS1753AK
Cardiac Devices·76 affected·Jun 3, 2021
High RiskFDA
Boston Scientific Corporation
VALITUDE CRT-P pacemaker, Models: a) U125 b) U128
Cardiac Devices·6,377 affected·Jun 3, 2021
High RiskFDA
Boston Scientific Corporation
Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722
Cardiac Devices·2,952 affected·Jun 3, 2021
CriticalFDA
Heartware, Inc.
HeartWare HVAD Driveline Extension Cable, REF 100
Cardiac Devices·338 affected·Jun 3, 2021
CriticalFDA
Boston Scientific Corporation
INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)
Cardiac Devices·40,224 affected·Jun 3, 2021
High RiskFDA
Arrow International Inc
Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Code: AI-05210 - Product Usage: intended for temporary use in ...
Cardiac Devices·48 affected·May 19, 2021
High RiskFDA
Arrow International Inc
Arrow Temporary Pacing Catheter/Introducer Kit 6Fr. pacing catheter 7Fr. introducer Product Code: AI-06210-IK - Product Usage: intended ...
Cardiac Devices·5 affected·May 19, 2021
High RiskFDA
Arrow International Inc
Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm, Product Code: AI-07154 - Product Usage: intended for temporary use in electrophys...
Cardiac Devices·4 affected·May 19, 2021
High RiskFDA
Arrow International Inc
Arrow Temporary Pacing Catheter/Introducer Kit 5Fr. pacing catheter 6 Fr. introducer Product Code: AI-07155-IK - Product Usage: intende...
Cardiac Devices·15 affected·May 19, 2021
High RiskFDA
Abbott Laboratories Inc. (st Jude Medical)
v.1.2 Upgrade Kit or v.1.2 upgrade installed on WorkMate Claris" System Display, Model H700124, The WorkMate Claris" System is a compu...
Cardiac Devices·9 affected·May 5, 2021
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
CareLink SmartSync Device Manager - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also...
Cardiac Devices·16,311 affected·Apr 6, 2021
High RiskFDA
Medtronic Inc., Cardiac Rhythm And Heart Failure (crhf)
Programmers - Product Usage: used to treat arrhythmias related to bradycardia. Additionally, CRT-P devices can also provide cardiac resyn...
Cardiac Devices·37,690 affected·Apr 6, 2021
High RiskFDA
Smiths Medical Asd Inc.
Left Heart Kit, Model Number M20268. for blood pressure monitoring.
Cardiac Devices·600 affected·Mar 31, 2021
High RiskFDA
Smiths Medical Asd Inc.
LogiCal Left Heart Kit, Model Number M20553. for blood pressure monitoring.
Cardiac Devices·3,740 affected·Mar 31, 2021
CriticalFDA
St. Jude Medical, Cardian Rhythm Management Division
ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to p...
Cardiac Devices·95,042 affected·Mar 15, 2021
High RiskFDA
Biotronik Inc
BIOTRONIK Ilestro 7 VR-T, DF-1, REF 383578, UDI: 04035479125349 - Product Usage: intended to provide ventricular tachycardia pacing and v...
Cardiac Devices·1,000 affected·Mar 8, 2021
High RiskFDA
Biotronik Inc
BIOTRONIK Ilestro 7 VR-T DX, DF-1, REF 383594, UDI: 04035479125509 - Product Usage: intended to provide ventricular tachycardia pacing an...
Cardiac Devices·3,664 affected·Mar 8, 2021
High RiskFDA
Biotronik Inc
BIOTRONIK INVENTRA 7, HF-T QP DF4 IS4, REF 393012, UDI: 04035479129286 - Product Usage: intended to provide ventricular tachycardia paci...
Cardiac Devices·702 affected·Mar 8, 2021
High RiskFDA
Biotronik Inc
BIOTRONIK ILIVIA NEO 7 DR-T DF-1 ProMRI, REF 429529, UDI: 04035479156749 - Product Usage: intended to provide ventricular tachycardia pac...
Cardiac Devices·98 affected·Mar 8, 2021
High RiskFDA
Biotronik Inc
BIOTRONIK ITREVIA 7, VR-T DF-4, REF 393041, UDI: 04035479129569 - Product Usage: intended to provide ventricular tachycardia pacing and v...
Cardiac Devices·670 affected·Mar 8, 2021