Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

254 results found for pacemaker Page 4 of 11
Remote Diagnostic Technologies Ltd.
Class II Ongoing
Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020
Reason: Defibrillator/pacemaker module (DPM) may encounter a problem causing communication from the Mainboard to the DPM to fail, leading to no or ineffective pacing with displayed error ...
Z-1825-2023 June 21, 2023 Farnborough, N/A
St. Jude Medical
Class II Ongoing
CardioMEMS HF System Patient Electronics System (PES), Model number CM1010, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart fai...
Reason: Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics Systems (HES) Model...
Z-1219-2023 March 15, 2023 Atlanta, GA
St. Jude Medical
Class II Ongoing
CardioMEMS HF System Patient Electronics System (PES), Model number CM1100, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart fai...
Reason: Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics Systems (HES) Model...
Z-1220-2023 March 15, 2023 Atlanta, GA
St. Jude Medical
Class II Ongoing
CardioMEMS HF System Patient Electronics System (PES), Model number CM1000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart fai...
Reason: Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics Systems (HES) Model...
Z-1218-2023 March 15, 2023 Atlanta, GA
St. Jude Medical
Class II Ongoing
CardioMEMS HF System Hospital Electronics System (HES), Model number CM3000, The CardioMEMS HF System provides pulmonary artery (PA) hemodynamic data used for the monitoring and management of heart fa...
Reason: Radiated Radiofrequency (RF) emissions of the CardioMEMS Patient Electronics Systems (PES) Models CM1000, CM1010 and CM1100 and CardioMEMS Hospital Electronics Systems (HES) Model...
Z-1221-2023 March 15, 2023 Atlanta, GA
MEDLINE INDUSTRIES, LP - Northfield
Class II Ongoing
Sterile Procedural Trays, labeled as the following: a. EP LAB PACEMAKER PACK b. OPEN HEART CDS c. OPEN HEART CDS d. AAA CDS e. OPEN HEART CDS f. PACEMAKER CDS g. HEART CDS h. VALVE PACK i. OPEN HEART...
Reason: Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Z-1067-2023 February 15, 2023 Northfield, IL
MEDLINE INDUSTRIES, LP - Northfield
Class II Ongoing
Sterile Procedural Trays, labeled as the following: a. CARDIAC CATH PACK-LF; b. ANGIOGRAPHY-NS-LF; c. EP BASIC SET UP PACK; d. IMPLANT PACK-LF; e. PORT PACEMAKER INSERTION PACK; ...
Reason: Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Z-1066-2023 February 15, 2023 Northfield, IL
DeRoyal Industries Inc
Class II Ongoing
DeRoyal PACEMAKER ICD PACK, REF 89-10216.03
Reason: XXX
Z-0680-2023 December 21, 2022 Powell, TN
Stradis Medical, LLC dba Stradis Healthcare
Class II Ongoing
HENRY SCHEIN, PACEMAKER PACK IItem No.570-2793
Reason: Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in...
Z-0519-2023 December 21, 2022 Peachtree Corners, GA
DeRoyal Industries Inc
Class II Ongoing
DeRoyal PACEMAKER ICD PACK, REF 89-10902.01
Reason: XXX
Z-0703-2023 December 21, 2022 Powell, TN
DeRoyal Industries Inc
Class II Ongoing
DeRoyal PACEMAKER ICD PACK, REF 89-10216.06
Reason: XXX
Z-0681-2023 December 21, 2022 Powell, TN
Spectranetics Corporation
Class II Ongoing
Philips Laser System, REF: LAS-100. Used in minimally invasive interventional procedures within the cardiovascular system, and for the removal of problematic pacemaker and defibrillator cardiac leads...
Reason: Laser System may detect Error 106 or Error 108 System Failures that will cause the system to enter non-recoverable safe state. The user will not be able to proceed until the error ...
Z-0221-2023 November 23, 2022 Colorado Springs, CO
American Contract Systems, Inc.
Class II Ongoing
Various Pacemaker Packs, Cardio Thoracic Packs
Reason: Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Z-1691-2022 September 14, 2022 Kansas City, MO
St. Jude Medical, Cardiac Rhythm Management Division
Class II Ongoing
Merlin PCS 3650 programmer Model 3330 software
Reason: There is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted battery longevity for certain p...
Z-1495-2022 August 10, 2022 Sylmar, CA
Philips North America Llc
Class II Terminated
The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive...
Reason: Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. This current voltage may lead to saturation and overheating of the coils that protect...
Z-2475-2021 September 22, 2021 Cambridge, MA
Philips North America Llc
Class II Terminated
The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive ...
Reason: Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. This current voltage may lead to saturation and overheating of the coils that protect...
Z-2474-2021 September 22, 2021 Cambridge, MA
Boston Scientific Corporation
Class I Ongoing
INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)
Reason: The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Expla...
Z-2020-2021 July 21, 2021 Saint Paul, MN
Boston Scientific Corporation
Class I Ongoing
INVIVE CRT-P, Model Numbers: a) V172 b) V173 c) V182 d) V183 e) W172 f) W173
Reason: The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Expla...
Z-2018-2021 July 21, 2021 Saint Paul, MN
Boston Scientific Corporation
Class I Ongoing
ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)
Reason: The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Expla...
Z-2015-2021 July 21, 2021 Saint Paul, MN
Boston Scientific Corporation
Class I Ongoing
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)
Reason: The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Expla...
Z-2016-2021 July 21, 2021 Saint Paul, MN
Boston Scientific Corporation
Class I Ongoing
INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273
Reason: The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Expla...
Z-2019-2021 July 21, 2021 Saint Paul, MN
Boston Scientific Corporation
Class I Ongoing
VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)
Reason: The dual chamber INGENIO family pacemakers or cardiac resynchronization therapy pacemakers (CRT-Ps) may initiate Safety Mode later in device life (i.e., prior to reaching the Expla...
Z-2017-2021 July 21, 2021 Saint Paul, MN
Boston Scientific Corporation
Class II Ongoing
Proponent pacemaker, Models: a) L200 b) L201 c) L209 d) L210 e) L211 f) L221 g) L231
Reason: Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery dep...
Z-1999-2021 July 14, 2021 Saint Paul, MN
Boston Scientific Corporation
Class II Ongoing
Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722
Reason: Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery dep...
Z-2001-2021 July 14, 2021 Saint Paul, MN
Boston Scientific Corporation
Class II Ongoing
VISIONIST CRT-P pacemaker, Models: a) U225 b) U226 c) U228
Reason: Latent release of small amounts of hydrogen within the pacemaker may cause a low voltage capacitor to become electrically compromised over time resulting in accelerated battery dep...
Z-2003-2021 July 14, 2021 Saint Paul, MN