Artivion, Inc - CryoValve SG Cryopreserved Pulmonary Human Heart Valve - Class 2 Recall
CryoValve SG Cryopreserved Pulmonary Human Heart Valve (Source: Medical Device Recalls)
Source: Medical Device Recalls - April 17, 2024 Category: Medical Devices Source Type: alerts
MEDLINE INDUSTRIES, LP - Northfield - Class 2 Recall
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ELECTROPHYSIOLOGY PACK-LF, Model Number: DYNJ0842825D; b. EMANUEL EP TRAY, Model Number: DYNJ49933I, DYNJ49933J; c. ENDO LASER ABLATION PK-LF, Model Number: DYNJ44808G; d. ENDO VASCULAR, Model Number: DYNJ51304B, DYNJ51304C; e. ENDO VASCULAR PACK, Model Numbers: DYNJ0678934D, DYNJ0678934F, DYNJ82567; f. ENDO VASCULAR PACK-LF, Model Number: DYNJ0676055N; g. ENDOVASCULAR, Model Numbers: DYNJ63343A, DYNJ63343B, DYNJ63343D, DYNJ63343F, DYNJ908880; h. ENDOVASCULAR CDS, Model Number: CDS983394I, CDS983394J, CDS...
Source: Medical Device Recalls - August 4, 2023 Category: Medical Devices Source Type: alerts
MEDLINE INDUSTRIES, LP - Northfield - Medline Probe Cover Kits - Class 2 Recall
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) MHC VASCULAR HYBRID PK-LF, Model Number DYNJ53433K; b) VEIN SPECIALISTS PACK, Model Number DYNJ53616A; c) SUMMIT SKIN AND VEIN PACK, Model Number DYNJ54014B; d) VEIN PACK, Model Number DYNJ54153B; e) RFD-ENDOVASCULAR OR PACK, Model Number DYNJ54265A; f) PEDI EP PACK, Model Number DYNJ54750G; g) EL PASO VERICOSE VEIN PACK, Model Number DYNJ54803C; h) LEE VEIN PACK, Model Number DYNJ54906B; i) HEART FAILURE PK, Model Number DYNJ55528A; j) HEART FAILURE PK, Model Number DYNJ55528B; k) HEART FAILURE PK, Model Number DYNJ55528C; l) ROCKWAY ...
Source: Medical Device Recalls - July 21, 2023 Category: Medical Devices Source Type: alerts
Medtronic Heart Valves Division - CoreValve Evolut PRO Delivery Catheter System - Class 2 Recall
CoreValve Evolut PRO Delivery Catheter System, REF: ENVPRO-14; ENVPRO-16; (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 10, 2021 Category: Medical Devices Source Type: alerts
Medtronic Heart Valves Division - CoreValve Evolut R Delivery Catheter System - Class 2 Recall
CoreValve Evolut R Delivery Catheter System, REF: ENVEOR-L; ENVEOR-N; (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 10, 2021 Category: Medical Devices Source Type: alerts
Medtronic Heart Valves Division - CoreValve Evolut PRO PLUS Delivery Catheter System - Class 2 Recall
CoreValve Evolut PRO PLUS Delivery Catheter System, REF: D-EVPROP2329US; D-EVPROP34US; (Source: Medical Device Recalls)
Source: Medical Device Recalls - July 10, 2021 Category: Medical Devices Source Type: alerts
CryoLife, Inc. - CryoValve SG Pulmonary Human Heart Valve - Class 2 Recall
CryoValve SG Pulmonary Human Heart Valve. The valve is cryopreserved in a tissue culture medium containing cryoprotectants within the innermost pouch of a three-pouch packaging system. The packaging system not only withstands ultracold temperatures, but also allows for aseptic introduction of the valve into the operating environment. Supercooling by liquid nitrogen boost is begun prior to crystallization to minimize ice crystal damage to the valve matrix. Finally, the valve is transferred to a liquid nitrogen freezer for long-term storage at or below 135¿C. CryoValve SG is distributed in two anatomic configurations: p...
Source: Medical Device Recalls - December 22, 2020 Category: Medical Devices Source Type: alerts
Medtronic Heart Valves Division - Evolut PRO System - Class 2 Recall
Evolut (TM) PRO+ System. With the following model numbers: a. EVPROPLUS-23US, Labeled as VLV EVPROPLUS-23US COMM JPN, VLV EVPROPLUS-23 COMM US; b. EVPROPLUS-26US, Labeled as VLV EVPROPLUS-26US COMM JPN, VLV EVPROPLUS-26 COMM US; c. EVPROPLUS-29US, Labeled as VLV EVPROPLUS-29US COMM JPN, VLV EVPROPLUS-29 COMM US; d. EVPROPLUS-34US, Labeled as VLV EVPROPLUS-34 COMM US, VLV EVPROPLUS-34 COMM US SA. (Source: Medical Device Recalls)
Source: Medical Device Recalls - December 11, 2020 Category: Medical Devices Source Type: alerts
Medtronic Heart Valves Division - CoreValve Evolut PRO System - Class 2 Recall
Evolut (TM) PRO System. With the following model numbers: a. EVOLUTPRO-23, Labeled as: VLV EVOLUTPRO-23 PRO COMM 29L OUS, VLV EVOLUTPRO-23 BLUE 29L COMM OUS, VLV EVOLUTPRO-23 BLUE COMM JPN, VLV EVOLUTPRO-23 BLUE 6L COMM OUS, VLV EVOLUTPRO-23 PRO COMM 29L CAN, VLV EVOLUTPRO-23 PRO COMM 29L OUS SA, VLV EVOLUTPRO-23 PRO COMM 29L AUS; b. EVOLUTPRO-23-US, Labeled as: VLV EVOLUTPRO-23-US BLUE COMM US, VLV EVOLUTPRO-23-US PRO BLNK US; c. EVOLUTPRO-26, Labeled as: VLV EVOLUTPRO-26 PRO COMM 29L OUS, VLV EVOLUTPRO-26 BLUE 6L COMM OUS, VLV EVOLUTPRO-26 PRO COMM 29L AUS, VLV EVOLUTPRO-26 BLUE COMM JPN, VLV EVOLUTPRO-26 BLUE 29L ...
Source: Medical Device Recalls - December 11, 2020 Category: Medical Devices Source Type: alerts
Medtronic Heart Valves Division - CoreValve Evolut R System - Class 2 Recall
Evolut (TM) R System. With the following model numbers: a. EVOLUTR-23, Labeled as VLV EVOLUTR-23 VT IR 6L COMM OUS, VLV EVOLUTR-23 TAV EVOLUT R CE 29L MX, VLV EVOLUTR-23 TAV CE AU 2Y MX, VLV EVOLUTR-23 TAV JPN MX, VLV EVOLUTR-23 GREY 29L COMM OUS, VLV EVOLUTR-23 TAV EVOLUT R CE 7L MX, VLV EVOLUTR-23 TAV EVOLUT R CE 26L MX, VLV EVOLUTR-23 TAV CA 2Y MX, VLV EVOLUTR-23 GREY 6L COMM OUS, VLV EVOLUTR-23-US TAV 23 US COMM MX; b. EVOLUTR-23-C, Labeled as VLV EVOLUTR-23-C TAV EVOLUT R US IDE MEX; c. EVOLUTR-23-US, Labeled as VLV EVOLUTR-23-US GREY COMM US, VLV EVOLUTR-23-US TAV 23 US COMM MX; d. EVOLUTR-26, Labeled as VLV ...
Source: Medical Device Recalls - December 11, 2020 Category: Medical Devices Source Type: alerts
Sorin Group Italia S.r.l. - PERCEVAL SUTURELESS HEART VALVE - Class 2 Recall
Perceval Dual Collapser, Size S/M, REF: ICV1235, Sterile EO, Rx Only, CE, UDI: 08022057014832 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 19, 2020 Category: Medical Devices Source Type: alerts
Sorin Group Italia S.r.l. - PERCEVAL SUTURELESS HEART VALVE - Class 2 Recall
Perceval Single Use Accessory Kit, Size S, REF: ICV1349, Sterile EO, Rx Only, CE, UDI: 8022057015211 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 19, 2020 Category: Medical Devices Source Type: alerts
Sorin Group Italia S.r.l. - PERCEVAL SUTURELESS HEART VALVE - Class 2 Recall
Perceval Single Use Accessory Kit, Size S, REF: ICV1345, Sterile EO, Rx Only, CE, UDI: 8022057015204 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 19, 2020 Category: Medical Devices Source Type: alerts
Sorin Group Italia S.r.l. - PERCEVAL SUTURELESS HEART VALVE - Class 2 Recall
Perceval Single Use Accessory Kit, Size M, REF: ICV1346, Sterile EO, Rx Only, CE, UDI: 8022057015228 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 19, 2020 Category: Medical Devices Source Type: alerts
Sorin Group Italia S.r.l. - PERCEVAL SUTURELESS HEART VALVE - Class 2 Recall
Perceval Single Use Accessory Kit, Size M, REF: ICV1350, Sterile EO, Rx Only, CE, UDI: 8022057015259 - Product Usage: he Dual Collapser is a component of the Perceval single use accessory kits used to reduce the Perceval Sutureless heart valve diameter before valve implant, allowing the Perceval implantation. (Source: Medical Device Recalls)
Source: Medical Device Recalls - September 19, 2020 Category: Medical Devices Source Type: alerts
