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Vanta INS Neurostimulator (Medtronic) – communication problem (2022)

The Implantable Neurostimulator Model may be susceptible to not communicating with the clinical programmer and/or patient programmer system.

FDAMar 30, 2022Nationwide• Medtronic Neuromodulation

Invacare TDX SP2 (Invacare) – battery wiring disconnect (2022)

The battery wiring harness on affected wheelchairs may become disconnected during shipment from the factory or during wheelchair use traversing large obstacles or after a jolt or impact to the wheelchair. The disconnection of the battery harness results in loss of power to the wheelchair.

FDAMar 30, 2022Nationwide• Invacare Corporation

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Vanta INS Neurostimulator (Medtronic) – communication problem (2022)

Invacare TDX SP2 (Invacare) – battery wiring disconnect (2022)

HeartWare VAD System (Heartware) – translation errors (2022)

Dragonfly OpStar Imaging Catheter (Abbott) – marker separation (2022)

Suave Antiperspirant Powder (Unilever) – Benzene Contamination (2022)

Suave Antiperspirant Fresh (Unilever) – Benzene Contamination (2022)

VITEK 2 Systems (bioMerieux) – software reporting issue (2022)

Smart Toe II Implant (Stryker) – label coverage (2022)

BD Anti-Kappa APC (BD Biosciences) – flow profile issue (2022)

Olympus Uretero-reno Videoscope (Olympus) – bending section crack (2022)

VITROS FSH Reagent Pack (Ortho-Clinical) – result imprecision (2022)

Puritan Bennett 980 Ventilator (Medtronic) – alarm malfunction (2022)

K-Wire (Arthrex) – dimension specification (2022)

BD Anti-Kappa PE (BD Biosciences) – flow profile issue (2022)

STRATAFIX Spiral Suture (Ethicon) – component mix-up (2022)

TactiCath Ablation Catheter (Abbott) – device activation problem (2022)

TearCare SmartHubs (Sight Sciences) – device clearance (2022)

IN.PACT AV Balloon Catheter (Medtronic) – packaging sterility (2022)

Mint Macaron (Elegant Foods) – Undeclared Colors (2022)

Elegant Foods Macaron Variety A (Elegant Foods) – undeclared colors (2022)