July 24, 2024Medical DevicesFDA
Abbott Medical recalls Proclaim 5 Elite Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only
Hazard: The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
July 24, 2024Medical DevicesFDA
Abbott Medical recalls Proclaim 7 Elite Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only
Hazard: The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
July 24, 2024Medical DevicesFDA
Abbott Medical recalls Abbott Proclaim DRG Implantable Pulse Generator, REF 3664, Sterile EO, Rx Only
Hazard: The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
July 24, 2024Medical DevicesFDA
Abbott Medical recalls Abbott Proclaim Plus 7 Implantable Pulse Generator, REF 3672, Sterile EO, Rx Only
Hazard: The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
July 24, 2024Medical DevicesFDA
Abbott Medical recalls Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3671, Sterile EO, Rx Only
Hazard: The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
July 24, 2024Medical DevicesFDA
Abbott Medical recalls Abbott Proclaim Plus 5 Implantable Pulse Generator, REF 3670, Sterile EO, Rx Only
Hazard: The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
July 24, 2024Medical DevicesFDA
Abbott Medical recalls Abbott Proclaim 7 Implantable Pulse Generator, REF 3667, Sterile EO, Rx Only
Hazard: The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
July 24, 2024Medical DevicesFDA
Abbott Medical recalls Abbott Proclaim 5 Implantable Pulse Generator, REF 3665, Sterile EO, Rx Only
Hazard: The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
July 24, 2024Medical DevicesFDA
Abbott Medical recalls Abbott Proclaim 7 Implantable Pulse Generator, REF 3663, Sterile EO, Rx Only
Hazard: The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
July 24, 2024Medical DevicesFDA
Abbott Medical recalls Abbott Proclaim XR 7 Implantable Pulse Generator, REF 3662, Sterile EO, Rx Only
Hazard: The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
July 24, 2024Medical DevicesFDA
Abbott Medical recalls Abbott Proclaim 5 Implantable Pulse Generator, REF 3661, Sterile EO, Rx Only
Hazard: The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
July 24, 2024Medical DevicesFDA
Abbott Medical recalls Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only
Hazard: The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling.
July 24, 2024Medical DevicesFDA
SEASPINE ORTHOPEDICS CORPORATION recalls Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Descrip
Hazard: Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces.
July 24, 2024Medical DevicesFDA
MED-EL Elektromedizinische Gereate, Gmbh recalls Mi1250 SYNCHRONY 2, Item Numbers: a) 39541, FLEXSOFT S-Vector; b) 39545, FLEX28 S-Vector; c) 39547, FLEX26 S-Vect
Hazard: A small number of devices may have a higher probability of a crack within the internal electronics substrate which could result in a non-functional device.
July 24, 2024Medical DevicesFDA
Medical Depot Inc. recalls Nitro Glide Knee Walker-offers users recovering from a below-the-knee injury the ability to remain mobile and glide thro
Hazard: The tiller separates from the base/front caster assembly. If the knee walker fails, a user may fall and sustain an injury
July 24, 2024Medical DevicesFDA
Medical Depot Inc. recalls Nitro Glide Knee Walker-offers users recovering from a below-the-knee injury the ability to remain mobile and glide thro
Hazard: The tiller separates from the base/front caster assembly. If the knee walker fails, a user may fall and sustain an injury
July 24, 2024Medical DevicesFDA
Qiagen Sciences LLC recalls QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic acids in molecu
Hazard: Heater shaker module does not perform heating if the temperature is set below 40¿C for static incubation steps when running IVD protocol QIAamp¿ DSP DNA Mini Kit (cat. no. 61304), Protocol: Isolation of genomic DNA from Gram-positive bacteria (Script filename: Kt_name_Bacteria (Gram+) or rY'east_Enzymatic Lysis_ V2) which could potentially cause delayed or erroneous results depending on the downstream assay.
July 24, 2024Medical DevicesFDA
Medtronic Neuromodulation recalls Medtronic Ascenda Intrathecal Catheter, Models: a) 8780 (114 cm); b) 8781 (140 cm); c) 8784 (catheter pump revisi
Hazard: Design update to the Ascenda Intrathecal Catheter Models 8780, 8781, and 8784. The intent of the design update is to reduce the potential for tissue growth into the Ascenda catheter connector which may potentially lead to catheter occlusion.
July 24, 2024Medical DevicesFDA
Becton, Dickinson and Company, BD Biosciences recalls BD Multitest 6-Color TBNK CE-IVD, REF: 644611; BD Multitest 6-Color TBNK Kit with BD Trucount Tubes CE-IVD, REF: 337166
Hazard: Multitest with compromised raw material used to assess immune system status may result in flow cytometry plot with unusual staining pattern, nonspecific aggregates, high background, double positive event increase on CD3+CD4+vsCD3+CD8+ and/or CD3-CD16+CD56+vsCD3-CD19+, contaminated antibodies, may lead to erroneous or delayed results, additional patient sample, might impact healthcare decisions
July 24, 2024Medical DevicesFDA
Boston Scientific Corporation recalls Autotome RX 20mm CUT WIRE Cannulating Sphincterotome, Material Number (UPN) M00545170. The device is used in selective c
Hazard: Foreign material may be present on the enclosed section of the cutting wire which may lead to inability to optimally bow the sphincterotome. This issue may lead to prolongation of procedure.
July 24, 2024Medical DevicesFDA
Cadwell Industries Inc recalls Cascade IOMAX Cortical Module, REF: 190296-200
Hazard: Electroneurodiagnostic medical device may contain a defective printed circuit board which may cause damage to the other internal components resulting in unintended electrical stimulation.
July 24, 2024Medical DevicesFDA
St. Jude Medical recalls St. Jude Medical Agilis NxT Steerable Introducer, REF 408309
Hazard: One lot of product has dilators that are too short and will not extend outside the introducer sheath.
July 24, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Volara System. Blue Ventilator Adapter Module. Intermittent positive pressure breathing device component.
Hazard: Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow.
July 24, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Volara System. Single Patient Use (SPU) Circuit 5kit for Volara and Single Patient Use (SPU) Circuit kit for Volara. In
Hazard: Potential of the handset plug to disconnect from the nebulizer port on the blue ventilator adapter. The handset plug is required to ensure proper operation and ventilator gas flow.
July 24, 2024Medical DevicesFDA
Abiomed, Inc. recalls Impella CP with SmartAssist, Product No.: 1000080 (REF 0048-0003). left heart support blood pump
Hazard: Nine (9) Impella CP pumps failed inspection and were inadvertently released.
July 17, 2024Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls RTLR190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Hazard: An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
July 17, 2024Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls RTL190904: 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Hazard: An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
July 17, 2024Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls RTL190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Hazard: An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
July 17, 2024Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls RTL190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Hazard: An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
July 17, 2024Medical DevicesFDA
Fresenius Medical Care Holdings, Inc. recalls 190395: 2008K@HOME MACHINE, SHORT CAB,OLC/DP,HP - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Hazard: An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.