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Showing 4801–4820 of 8393 results

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Total Hip Kit, REF DYNJ903275S; surgical convenience kit (MEDLINE INDUSTRIES, LP Northfield) – the prep solution included in the tot... (2023)

The prep solution included in the Total Hip Kit expires prior to the expiration date of the Kit.

FDAJul 3, 2023Nationwide• MEDLINE INDUSTRIES, LP Northfield

Wireless Foot Switch distributed with Philips Allura Xper... (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands) – loss of availability of the wireless ... (2023)

Loss of availability of the wireless foot switch during procedures.

FDAJun 30, 2023Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

LifeSPARC Pump (part number 5800-0000) contained within T... (Cardiac Assist, Inc) – epoxy used during manufacturing of th... (2023)

Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. if undetectable curing may result in added risk of early pump failure,

Moderate

FDAJun 30, 2023Nationwide• Cardiac Assist, Inc

Impella RP Flex with SmartAssist intracardiac microaxial ... (Abiomed, Inc.) – a higher than expected rate of throm... (2023)

A higher than expected rate of thrombus formation or deposition has been observed. The risk is for thrombus formations or deposits on indwelling central venous lines or cannulas may break free and enter into the Impella RP Flex, resulting in reduced flow, loss of support, or hemolysis

FDAJun 29, 2023Nationwide• Abiomed, Inc.

Centurion FMS Pak (Alcon Research, LTD.) – plastic contamination (2023)

Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.

FDAJun 28, 2023Nationwide• Alcon Research, LTD.

ACROBAT SUV Vacuum Off-Pump System, Part Number C-OM-9000... (Maquet Cardiovascular, LLC) – the standard blade may not securely l... (2023)

The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stabilization and positioning of heart, release of device component into the patient, and/or a procedural delay and/or conversion.

FDAJun 28, 2023Nationwide• Maquet Cardiovascular, LLC

ACROBAT V Vacuum Off-Pump System, Part Number C-OM-9100S.... (Maquet Cardiovascular, LLC) – the standard blade may not securely l... (2023)

The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stabilization and positioning of heart, release of device component into the patient, and/or a procedural delay and/or conversion.

FDAJun 28, 2023Nationwide• Maquet Cardiovascular, LLC

ACCESSRAIL Platform (Standard Blade) Part Number SB-1000,... (Maquet Cardiovascular, LLC) – the standard blade may not securely l... (2023)

The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stabilization and positioning of heart, release of device component into the patient, and/or a procedural delay and/or conversion.

FDAJun 28, 2023Nationwide• Maquet Cardiovascular, LLC

stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to... (Stryker Corporation) – there is potential the device inside ... (2023)

There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-430 but package contains a 5820-107-530 device or vice versa).

FDAJun 28, 2023Nationwide• Stryker Corporation

The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) ... (Stryker Corporation) – there is potential the device inside ... (2023)

There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-030 but package contains a 5820-107-530 device).

FDAJun 28, 2023Nationwide• Stryker Corporation

Legion FMS Pak (Alcon Research, LTD.) – plastic contamination (2023)

Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.

FDAJun 28, 2023Nationwide• Alcon Research, LTD.

Phaco Standalone Tips (Alcon Research, LTD.) – plastic contamination (2023)

Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.

FDAJun 28, 2023Nationwide• Alcon Research, LTD.

MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis ... – catheter center lumen was found to ha... (2023)

Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus

FDAJun 28, 2023Nationwide

MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 c... – catheter center lumen was found to ha... (2023)

Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus

FDAJun 28, 2023Nationwide

ACROBAT-i Vacuum Stabilizer System, Part Number C-OM-1000... (Maquet Cardiovascular, LLC) – the standard blade may not securely l... (2023)

The Standard Blade may not securely latch onto the Activator Drive. This may result in the inability to stabilize and position or may result in the loss of stabilization and positioning of heart, release of device component into the patient, and/or a procedural delay and/or conversion.

FDAJun 28, 2023Nationwide• Maquet Cardiovascular, LLC

Constellation Procedure Pak (Alcon Research, LTD.) – plastic contamination (2023)

Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.

FDAJun 28, 2023Nationwide• Alcon Research, LTD.

stryker 3.0MM Precision Neuro Match Head, REF 5820-107-53... (Stryker Corporation) – there is potential the device inside ... (2023)

There is potential the device inside the package may not match the product information on the outer label (e.g., label states 5820-107-430 but package contains a 5820-107-530 device or vice versa).

FDAJun 28, 2023Nationwide• Stryker Corporation

Alcon Custom Pak (Alcon Research, LTD.) – plastic contamination (2023)

Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.

FDAJun 28, 2023Nationwide• Alcon Research, LTD.

Medtronic REF 46915 Duet External Drainage and Monitoring... (Medtronic Neurosurgery) – product labeling contains incorrect e... (2023)

Product labeling contains incorrect expiration date

FDAJun 28, 2023Nationwide• Medtronic Neurosurgery

Infinity FMS Pak (Alcon Research, LTD.) – plastic contamination (2023)

Reports of patient injury during use in procedures due to potential for plastic debris from over-tightening with included plastic wrench.

FDAJun 28, 2023Nationwide• Alcon Research, LTD.

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