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Showing 1861–1880 of 8393 results

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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

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

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.

Moderate

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

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

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

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.

FDADec 12, 2024Nationwide• Boston Scientific Corporation

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

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

Neo-Tee T-Piece Resuscitator (Mercury Medical) – Flow Controller Defect (2024)

Gas powered emergency resuscitator has a circuit flow controller manufactured with an undersized spring, which may cause resuscitator not reach the high and low ends of the PIP and PEEP pressure ranges, which may cause a loss of positive pressure, impacting effective ventilation of the patient.

FDADec 10, 2024Nationwide• Mercury Enterprises, Inc. dba Mercury Medical

Idylla Instrument (Biocartis) – False-Positive MSI-H Results (2024)

False-positive MSI-H results generated by the Idylla MSI Test.

FDADec 10, 2024AL, CA, NJ +2 more• Biocartis Nv B 3 Generaal De Wittelaan 11 Mechelen Belgium

JMC5A Oxygen Concentrator (Jiangsu Jumao) – Fire Hazard Risk (2024)

Oxygen concentrator may melt or catch on fire during use.

FDADec 9, 2024OH• JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD No

VasoView Hemopro 2 with Vasoshield (Maquet) – Multiple Component Risks (2024)

Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool

FDADec 9, 2024Nationwide• Maquet Cardiovascular, LLC

VasoView HemoPro 2 Vessel Harvesting System (Maquet) – Multiple Component Risks (2024)

Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool

FDADec 9, 2024Nationwide• Maquet Cardiovascular, LLC

Ivenix Infusion System (Fresenius Kabi) – Pneumatic Valve Failure (2024)

Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could prevent the pump from being used.

FDADec 6, 2024ID, MN, NV +3 more• Fresenius Kabi USA, LLC

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