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Vercise Genus DBS Implantable Pulse Generator (Boston Scientific) – system check issue (2024)

Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset. The device reset could lead transient loss of stimulation; patients may experience undesired sensations, transient worsening of movement disorder symptoms, which may lead patient to request surgical intervention for replacement or revision.

High

FDAApr 18, 2024Nationwide• Boston Scientific Neuromodulation Corporation

OPTETRAK Three Peg Patella (Exactech) – packaging problem (2024)

Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.

High

FDAApr 18, 2024Nationwide

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Vercise Genus DBS Implantable Pulse Generator (Boston Scientific) – system check issue (2024)

OPTETRAK Three Peg Patella (Exactech) – packaging problem (2024)

Mi1250 SYNCHRONY 2 (MED-EL) – internal electronics crack (2024)

OPTETRAK Advanced Patella (Exactech) – packaging problem (2024)

Beckman Coulter DxL 9000 Analyzer (Beckman Coulter) – calibration request problem (2024)

OPTETRAK Inset Patella (Exactech) – packaging problem (2024)

OES 4000 Hysteroscope (Olympus) – leakage test omission (2024)

Alaris Pump Infusion Set (Unknown) – tubing detachment risk (2024)

Synchro Neuro Guidewires (Stryker) – PTFE coating damage (2024)

Medline Syringes (Medline) – quality and leakage issues (2024)

Curity Flexible Adhesive Bandage (Cardinal Health) – latex contamination (2024)

Blood Pump Rotor (Fresenius) – component dislodgement (2024)

Syntel Silicone Thrombectomy Catheter (LeMaitre) – guide tip damage (2024)

Surface Mounter Series (Yamaha) – laser certification issue (2024)

Optical Inspection System (Yamaha) – laser certification issue (2024)

Integra Cranial Access Kit (Integra) – packaging integrity (2024)

Intelli-C X-Ray System (NRT X-RAY) – uncontrolled motion (2024)

2008T BlueStar Hemodialysis Machine (Fresenius) – pump rotor issue (2024)

COBALT XT VR MRI SureScan Defibrillator (Medtronic) – manufacturing defect (2024)

PRIMO MRI VR SureScan Defibrillator (Medtronic) – manufacturing defect (2024)