May 22, 2024Medical DevicesFDA
Boston Scientific Corporation recalls Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR3.5 (5PK), REF H74908526012; cardiac catheter
Hazard: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
May 15, 2024Medical DevicesFDA
Randox Laboratories Ltd. recalls Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and
Hazard: Foam gasket on the Evidence MultiSTAT chip heater assembly may not perform as expected. Foam that is not functioning as expected may cause light to leak into the Charged Coupled Device (CCD) Camera during imaging. This will affect the testing and may delay in reporting results.
May 15, 2024Medical DevicesFDA
Stryker Leibinger GmbH & Co. KG recalls Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization and rigid fixation of the bony
Hazard: Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), may cause a delay in procedure
May 15, 2024Medical DevicesFDA
NRT X-RAY A/S recalls Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Inte
Hazard: X-ray system C-arm may experience uncontrolled motion if 1) AC motor controller firmware has a faulty setting, 2) the Motor/gear assembly is worn, 3) CAT movement is driven at maximum speed and angulated more than 75 deg. from vertical, and 4) the emergency stop or touch guard is activated during the breaking sequence, which could lead to the C-arm hitting the patient or operator.
May 15, 2024Medical DevicesFDA
GE Medical Systems, SCS recalls GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems
Hazard: GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fall of the Detector/Elevator or X-ray tube of the frontal Gantry assembly.
May 15, 2024Medical DevicesFDA
GE Medical Systems, SCS recalls GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems
Hazard: GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fall of the Detector/Elevator or X-ray tube of the frontal Gantry assembly.
May 15, 2024Medical DevicesFDA
GE Medical Systems, SCS recalls GE Healthcare Allia IGS 7 OR, Interventional fluoroscopic x-ray systems
Hazard: GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fall of the Detector/Elevator or X-ray tube of the frontal Gantry assembly.
May 15, 2024Medical DevicesFDA
GE Medical Systems, SCS recalls GE Healthcare Allia IGS 7, Interventional fluoroscopic x-ray systems
Hazard: GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fall of the Detector/Elevator or X-ray tube of the frontal Gantry assembly.
May 15, 2024Medical DevicesFDA
GE Medical Systems, SCS recalls GE Healthcare Interact Discovery RT, Interventional fluoroscopic x-ray systems
Hazard: GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fall of the Detector/Elevator or X-ray tube of the frontal Gantry assembly.
May 15, 2024Medical DevicesFDA
GE Medical Systems, SCS recalls GE Healthcare Innova IGS 6, Interventional fluoroscopic x-ray systems
Hazard: GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fall of the Detector/Elevator or X-ray tube of the frontal Gantry assembly.
May 15, 2024Medical DevicesFDA
GE Medical Systems, SCS recalls GE Healthcare Innova IGS 5, computed tomography x-ray system
Hazard: GE HealthCare has become aware of the potential that adhesive material might not have been applied to some bolts of certain Innova IGS, Discovery IGS, Interact IGS, Allia IGS and Allia Pulse IGS products. This could result in a potential fall of the Detector/Elevator or X-ray tube of the frontal Gantry assembly.
May 15, 2024Medical DevicesFDA
Medtronic Navigation, Inc. recalls Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid fo
Hazard: Due to a software issue, there is the potential for a missing digit, letter, or decimal in either the "distance to target" or "tip stop point" display during navigation.
May 15, 2024Medical DevicesFDA
Baxter Healthcare Corporation recalls Baxter Spectrum IQ Infusion Pump, Product Code 3570009
Hazard: One device was improperly performed testing prior to release from a Service Center.
May 15, 2024Medical DevicesFDA
Angiodynamics, Inc. recalls BioFlo DuraMax 15.5F 24cm Single Valve Sheath VascPak Kit- Indicated for use in attaining Long-Term vascular access for
Hazard: Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
May 15, 2024Medical DevicesFDA
Angiodynamics, Inc. recalls DURAMAX STACKED TIP 32 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemo
Hazard: Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
May 15, 2024Medical DevicesFDA
Angiodynamics, Inc. recalls DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemo
Hazard: XXX
May 15, 2024Medical DevicesFDA
Angiodynamics, Inc. recalls DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hem
Hazard: Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
May 15, 2024Medical DevicesFDA
Angiodynamics, Inc. recalls DURAMAX STACKED TIP 32CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialy
Hazard: Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
May 15, 2024Medical DevicesFDA
Angiodynamics, Inc. recalls DURAMAX STACKED TIP 28CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialy
Hazard: Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
May 15, 2024Medical DevicesFDA
Angiodynamics, Inc. recalls DURAMAX STACKED TIP 28CM STR. BASIC KIT, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialy
Hazard: Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
May 15, 2024Medical DevicesFDA
Angiodynamics, Inc. recalls DURAMAX STACKED TIP 24CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialy
Hazard: Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
May 15, 2024Medical DevicesFDA
Angiodynamics, Inc. recalls DURAMAX STACKED TIP 24CM STR. BASIC KIT, 1-UP PG Product Number: H787103028031
Hazard: Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
May 15, 2024Medical DevicesFDA
Angiodynamics, Inc. recalls DURAFLOW 2, 28CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and A
Hazard: Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
May 15, 2024Medical DevicesFDA
Angiodynamics, Inc. recalls DURAFLOW 2, 24CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and A
Hazard: Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
May 15, 2024Medical DevicesFDA
Angiodynamics, Inc. recalls DURAFLOW 2, 55CM STRAIGHT BASIC KIT PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and
Hazard: Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
May 15, 2024Medical DevicesFDA
Angiodynamics, Inc. recalls DURAFLOW 2, 32CM STRAIGHT BASIC KIT PG-Indicated for use in attaining Long-Term vascular access for Hemodialysis and A
Hazard: Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
May 15, 2024Medical DevicesFDA
Angiodynamics, Inc. recalls DURAFLOW 2, 28CM STRAIGHT BASIC KIT, 1 per Bx PG-Indicated for use in attaining Long-Term vascular access for Hemodial
Hazard: Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
May 15, 2024Medical DevicesFDA
Angiodynamics, Inc. recalls DURAFLOW 2, 24CM STRAIGHT BASIC KIT -Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apher
Hazard: Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
May 15, 2024Medical DevicesFDA
Randox Laboratories Ltd. recalls Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 c
Hazard: Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351 & CAL10388, is running with a negative bias on RX Series instruments compared to other methods.
May 15, 2024Medical DevicesFDA
SPINEART SA recalls PERLA TL 25D SCREW REF: TLF-DS 45 25-S TLF-DS 45 30-S TLF-DS 45 35-S TLF-DS 45 40-S TLF-DS 45 45-S TLF-DS 55 30-
Hazard: Due to receiving information regarding difficulties with the insertion of a setscrew inside a screw head. Issues involved, either: 1. The setscrew is not tightened to torque 2. The setscrew is tightened to torque but position askew