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Showing 1861–1880 of 22584 results

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Wolf-Pak Dressing Change Kit (Trinity Sterile) – Package Sterility Risk (2024)

Potential for hole in package compromising sterility of the medical kit.

FDADec 13, 2024Nationwide• Trinity Sterile, Inc.

Tacy Medical Dressing Change Tray (Trinity Sterile) – Package Sterility Risk (2024)

Potential for hole in package compromising sterility of the medical kit.

FDADec 13, 2024Nationwide• Trinity Sterile, Inc.

VALITUDE CRT-P (Boston Scientific) – Safety Mode Potential (2024)

A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.

Moderate

FDADec 12, 2024Nationwide• Boston Scientific Corporation

SenTiva Microburst VNS Generator (LivaNova) – Stimulation Interruption Risk (2024)

Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanically activated component that may become stuck in a closed position, which may result in patients returning to baseline seizure frequency or depressive symptoms and in the longer term, patients may be required to undergo generator replacement surgery to replace their device.

FDADec 12, 2024AK, AZ, AR +38 more• LivaNova USA, Inc.

Select Series Arterial Cannula (Medtronic) – Incorrect Labeling (2024)

Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.

FDADec 12, 2024Nationwide• Medtronic Perfusion Systems

EOPA Arterial Cannula (Medtronic) – Incorrect Labeling (2024)

Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.

FDADec 12, 2024Nationwide• Medtronic Perfusion Systems

PROPONENT DR Pacemaker (Boston Scientific) – Safety Mode Potential (2024)

A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.

FDADec 12, 2024Nationwide• Boston Scientific Corporation

ESSENTIO DR Pacemaker (Boston Scientific) – Safety Mode Potential (2024)

A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.

FDADec 12, 2024Nationwide• Boston Scientific Corporation

VISIONIST CRT-P (Boston Scientific) – Safety Mode Potential (2024)

A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.

FDADec 12, 2024Nationwide• Boston Scientific Corporation

ALTRUA 2 DR Pacemaker (Boston Scientific) – Safety Mode Potential (2024)

A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.

FDADec 12, 2024Nationwide• Boston Scientific Corporation

SenTiva VNS Generator (LivaNova) – Stimulation Interruption Risk (2024)

Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanically activated component that may become stuck in a closed position, which may result in patients returning to baseline seizure frequency or depressive symptoms and in the longer term, patients may be required to undergo generator replacement surgery to replace their device.

FDADec 12, 2024AK, AZ, AR +38 more• LivaNova USA, Inc.

Impella RP Flex with SmartAssist (Abiomed) – Optical Sensor Damage (2024)

Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of Central Venous (CV) Placement Signal, Pulmonary Artery (PA) Placement Signal & Pulmonary Artery Pulse Index (PAPi) metrics. Abiomed is reinforcing that there is a risk of potential interaction between the tip of guidewires, indwelling central venous lines or devices and inlet of the Impella pumps listed above during the insertion, manipulation, and removal of those devices. The interaction may result in optical sensor damage, temporary pump stop, or permanent pump stop.

FDADec 12, 2024Nationwide• Abiomed, Inc.

Impella RP with SmartAssist (Abiomed) – Optical Sensor Damage (2024)

Optical Sensors have been damaged due to physical interaction between the inlet and another device resulting in a Placement Signal Not Reliable (PSNR) alarm and loss of Central Venous (CV) Placement Signal, Pulmonary Artery (PA) Placement Signal & Pulmonary Artery Pulse Index (PAPi) metrics. Abiomed is reinforcing that there is a risk of potential interaction between the tip of guidewires, indwelling central venous lines or devices and inlet of the Impella pumps listed above during the insertion, manipulation, and removal of those devices. The interaction may result in optical sensor damage, temporary pump stop, or permanent pump stop.

FDADec 12, 2024Nationwide• Abiomed, Inc.

ACCOLADE DR Pacemaker (Boston Scientific) – Safety Mode Potential (2024)

A subset of devices from the ACCOLADE Family of Pacemakers and CRT-Ps, built before September 2018, have an increased potential to initiate Safety Mode during telemetry or other normal, higher-power operations due to latent high battery impedance.

FDADec 12, 2024Nationwide• Boston Scientific Corporation

DLP Pediatric Arterial Cannulae (Medtronic) – Incorrect Labeling (2024)

Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.

FDADec 12, 2024Nationwide• Medtronic Perfusion Systems

HealthFirst Mail-In Monitoring System (HF Acquisition) – Envelope Printing Error (2024)

Spore test strip monitoring system, designed for routine monitoring of sterilization processes, may have a printing error on the return envelope that may cause spore test results to be reported to the incorrect customer's account.

FDADec 11, 2024AL, AK, AZ +47 more• HF Acquisition Co LLC

AquaFlexFlow UF 500 Plus (Nuwellis) – Weight Mismatch Risk (2024)

Laceration Risk

The AquaFlexFlow UF 500 Plus extracorporeal blood circuit used with the Aquadex SmartFlow and FlexFlow Systems may indicate "Ultrafiltrate Weight Mismatch" or Excessive Weight Mismatch Alarms while in use. If not addressed, this failure could result in excess fluid removal from a patient leading to Acute Volume Depletion. This failure is especially serious when the Aquadex System is being used on pediatric patients.

FDADec 11, 2024Nationwide• Nuwellis Inc

LVIS Intraluminal Support Device (MicroVention) – Stent Deployment Issue (2024)

Potential for Polytetrafluoethylene (PTFE) material encasing the stent loop may prevent the stent from being pushed out of the introducer.

FDADec 11, 2024Nationwide• MICROVENTION INC.

Medtronic NanoCross Elite PTA Catheter (Unknown) – Balloon Deflation Issue (2024)

There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.

FDADec 10, 2024Nationwide

EMPOWR 3D Knee Tibial Insert (Unknown) – Surgical Kit Mismatch (2024)

Knee insert package may contain an acetabular system, which may cause surgical delay to get a new product.

FDADec 10, 2024Nationwide

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