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Showing 601–620 of 1734 results

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i-STAT CG4+ Cartridge (Abbott) – Measurement Range Issue (2025)

Lack of a 510(k) premarket clearance for the i-STAT CG4+ cartridge to reflect updated sample type for lactate and measurement ranges for pH and PO2.

FDAAug 21, 2025Nationwide• Abbott Point Of Care Inc.

Frontier 14mm Distraction Pin (Folsom) – Shelf Life Concern (2025)

Labeling includes shelf life that has not been validated.

FDAAug 21, 2025Nationwide• Folsom Metal Products, Inc.

Frontier 12mm Distraction Pin (Folsom) – Shelf Life Concern (2025)

Labeling includes shelf life that has not been validated.

Low

FDAAug 21, 2025Nationwide• Folsom Metal Products, Inc.

i-STAT EG7+ Cartridge (Abbott) – Sample Type Issue (2025)

Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.

FDAAug 21, 2025Nationwide• Abbott Point Of Care Inc.

Medline Valve Pack (Unknown) – Catheter Shape Retention (2025)

The kits contain certain lots of cannula products where the catheter may not retain its shape.

FDAAug 21, 2025Nationwide

i-STAT EG6+ Cartridge (Abbott) – Sample Type Issue (2025)

Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.

FDAAug 21, 2025Nationwide• Abbott Point Of Care Inc.

Frontier 12mm Distraction Pin (Folsom) – Shelf Life Concern (2025)

Labeling includes shelf life that has not been validated.

FDAAug 21, 2025Nationwide• Folsom Metal Products, Inc.

Frontier 14mm Distraction Pin (Folsom) – Shelf Life Concern (2025)

Labeling includes shelf life that has not been validated.

FDAAug 21, 2025Nationwide• Folsom Metal Products, Inc.

Venclose digiRF Generator (Bard) – Wiring Detection Feature (2025)

Laceration Risk

Software version 3.35 of the Venclose digiRF Generator incorporates a catheter verification feature specifically designed to detect internal wiring anomalies in Venclose EVSRF Ablation Catheters prior to clinical use. This automated diagnostic check is executed immediately upon catheter connection to the generator, occurring before the procedure interface becomes accessible. When a catheter fails this verification process, the generator displays a Red X indicator on the screen without accompanying error codes, effectively disabling catheter functionality. However, BD has determined that software version 3.35 generates false positive failures due to temperature-dependent verification parameters, incorrectly flagging properly functioning Venclose EVSRF Ablation Catheters as defective when the catheter temperature is not at steady state during the check initiation.

FDAAug 21, 2025Nationwide• Bard Peripheral Vascular Inc 1625 W 3rd St Bldg 1 850 W. Rio Salado Prkwy. Tempe AZ 85281-2438

Frontier 16mm Distraction Pin (Folsom) – Shelf Life Concern (2025)

Labeling includes shelf life that has not been validated.

FDAAug 21, 2025Nationwide• Folsom Metal Products, Inc.

i-STAT CG8+ Cartridge (Abbott) – Sample Type Problem (2025)

Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect updated sample type for potassium and ionized calcium and measurement ranges for pH and PO2.

FDAAug 21, 2025Nationwide• Abbott Point Of Care Inc.

PROPONENT DR SL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

FDAAug 20, 2025Nationwide• Boston Scientific Corporation

ACCOLADE DR EL MRI Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

FDAAug 20, 2025Nationwide• Boston Scientific Corporation

PROPONENT SR SL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

FDAAug 20, 2025Nationwide• Boston Scientific Corporation

PROPONENT DR EL MRI Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

FDAAug 20, 2025Nationwide• Boston Scientific Corporation

VALITUDE CRT-P EL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

FDAAug 20, 2025Nationwide• Boston Scientific Corporation

ESSENTIO SR SL MRI Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

FDAAug 20, 2025Nationwide• Boston Scientific Corporation

PROPONENT DR EL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

FDAAug 20, 2025Nationwide• Boston Scientific Corporation

PROPONENT DR VDD SL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

FDAAug 20, 2025Nationwide• Boston Scientific Corporation

ALTRUA 2 DR EL Pacemaker (Boston Scientific) – Safety Mode Issue (2025)

Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps).

FDAAug 20, 2025Nationwide• Boston Scientific Corporation

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