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Gallant HF Defibrillator (St. Jude Medical) – Bluetooth Malfunction (2022)

Bluetooth malfunction impacting Gallant devices post-implant. The failure causes the device to enter an inductive-only telemetry mode with a loss of Bluetooth communication. The Bluetooth malfunction results in the inability to remotely monitor these devices and resulted in reduced battery longevity.

FDAMar 10, 2022Nationwide• St. Jude Medical, Cardiac Rhythm Management Division

EasyFuse Dynamic Compression System (Wright Medical) – Instrument Jam Risk (2022)

The drill and adjustable drill guide can jam/bind intraoperatively resulting in the drill guide breaking.

FDAMar 10, 2022FL, NC, OH +1 more• Wright Medical Technology, Inc.

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Gallant HF Defibrillator (St. Jude Medical) – Bluetooth Malfunction (2022)

EasyFuse Dynamic Compression System (Wright Medical) – Instrument Jam Risk (2022)

Medline Laryngeal Masks (Medline) – Mask Disconnection Risk (2022)

EVIS EXERA II Bronchovideoscope (Olympus) – Reprocessing Instructions (2022)

OES Bronchofiberscope (Olympus) – Reprocessing Instructions (2022)

OnGuard2 CSTD Bag Adaptor (Simplivia) – Medication Spillage Risk (2022)

ARCHITECT Myoglobin Calibrators (Abbott) – Testing Accuracy Issue (2022)

ROTAWIRE Drive (Boston Scientific) – Sterility Compromise (2022)

EVIS EXERA Bronchovideoscope (Olympus) – Reprocessing Instructions (2022)

EVIS EXERA Bronchofibervideoscope (Olympus) – Reprocessing Instructions (2022)

YSIO X.Pree (Siemens) – X-Ray Collimation Issue (2022)

Acuson 9vE4 Transducer (Siemens) – Thermal Index Limit Exceed (2022)

Siemens SOMATOM Scanner (Siemens) – Software Workflow Interruption (2022)

Alprostadil/Papaverine/Phentolamine (Tailor Made Compounding) – Sterility Risk (2022)

Sermorelin/Glycine (Tailor Made) – Sterility Concern (2022)

Vitamin D3 (Tailor Made Compounding) – Sterility Risk (2022)

Methylcobalamin (Tailor Made) – Sterility Concern (2022)

GAC (Tailor Made) – Sterility Concern (2022)

Teriparatide (Tailor Made Compounding) – Sterility Risk (2022)

Vitamin B-Complex (Tailor Made) – Sterility Concern (2022)