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Other Medical Devices

🏥 Medical Devices • 15,809 recalls

Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.

Arrow International, Inc., Division of Teleflex Medical

Class I - Dangerous

The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.

Feb 10, 2016 Other Medical Devices Nationwide View Details →

Ultra 8 IAB: 8Fr 30cc; Product Code: IAB-05830-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.

Arrow International, Inc., Division of Teleflex Medical

Class I - Dangerous

The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.

Feb 10, 2016 Other Medical Devices Nationwide View Details →

RediGuard IAB: 7Fr 30cc; Product Code: IAB-S730C The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.

Arrow International, Inc., Division of Teleflex Medical

Class I - Dangerous

The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.

Feb 10, 2016 Other Medical Devices Nationwide View Details →

UltraFlex IAB: 7.5Fr 30cc; Product Code: IAB-06830-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.

Arrow International, Inc., Division of Teleflex Medical

Class I - Dangerous

The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.

Feb 10, 2016 Other Medical Devices Nationwide View Details →

FiberOptix Ultra 8 IAB: 8Fr 30cc The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.

Arrow International, Inc., Division of Teleflex Medical

Class I - Dangerous

The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.

Feb 10, 2016 Other Medical Devices Nationwide View Details →

BladderScan BVI 9600, Model Numbers: 0270-0451, 0270-0452, 0270-0754, and U270-0451. AortaScan AMI 9700, Model Numbers: 0270-0636, 0270-0639, and U270-0636.

Verathon

Class I - Dangerous

The firm is providing customers with an updated Operations and Maintenance Manual for each of the BladderScan BVI 9600 and AortaScan AMI 9700 devices. The updated Operations and Maintenance Manuals clarify that these devices should not be used for the screening, detection, or diagnosis of abdominal aortic aneurysms (AAAs).

Nov 30, 2015 Other Medical Devices Nationwide View Details →

IMPAK ACRYLIC RESIN LIQUID FOR BOTH IMPAK & IMPAK-PF POWDERS 1 qt. size (946 cc), Part Number 3306, and 11 oz. size (325 cc), Part Number 3748. Indicated for relining a denture surface for repairing a fractured denture, or forming a new denture base.

CMP Industries

Class I - Dangerous

During the current inspection of CMP Industries, the FDA Investigator discovered that the firm had conducted a recall of Impak Acrylic Liquid Batch 103113 in 2013 due to potential rust without notifying the district.

Nov 18, 2013 Other Medical Devices View Details →

UltraFlex IAB: 7.5Fr 40cc; Product Code: IAB-06840-U The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.

Arrow International, Inc., Division of Teleflex Medical

Class I - Dangerous

The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.

Feb 10, 2016 Other Medical Devices Nationwide View Details →

Percutaneous Insertion Tray; Product Code: IAK-S7IT The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.

Arrow International, Inc., Division of Teleflex Medical

Class I - Dangerous

The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.

Feb 10, 2016 Other Medical Devices Nationwide View Details →

iChem VELOCITY Automated Urine Chemistry, Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713, 800-7714, 800-7719, 800-7720 iChem VELOCITY Urine Chemistry Strips, Catalog No. 800-7212 & 800-7212-001

Beckman Coulter

Class I - Dangerous

Iris International noted loose or missing analyte pads found in several locations (strip vial, strip provider module, strip conveyor system or waste container) that are undetectable by the iChemVELOCITY System.

Jan 13, 2016 Other Medical Devices View Details →

Stryker Position Pro Mattress. Mattress, Air Flotation, Alternating Pressure. PositionPRO is a powered pressure relief support surface with low air loss (LAL) intended for medical purposes. PositionPRO consists of multiple air cells filled and emptied by an integrated control unit to provide changes in the distribution of body weight for pressure relief. PositionPRO offers turn assist. PositionPRO is for use with GoBed II¿, Secure II/3¿, InTouch¿, and Epic II¿ 84 in. x 35 in. flat deck frames. This surface is powered via an AC power cord that comes in either a 4 foot long option (PN QDF8087) or 15 foot long option (PN QDF8088). The 4 foot long option is used when the surface is plugged into the auxiliary outlet of the bed. The 15 foot long option is utilized when the surface needs to be plugged into a wall outlet. This product uses a power cord, manufactured by ElectriCord that plugs into the wall outlet or the auxiliary outlet of the bed that the surface is placed onto.

Stryker Medical Division of Stryker

Class I - Dangerous

Potential for power cord to melt; hazards include electric shock and fire.

Dec 3, 2015 Other Medical Devices Nationwide View Details →

FiberOptix Ultra 8 IAB: 8Fr 40cc; Product Code: IAB-05840-LWS The Arrow¿ IAB is utilized for intra aortic balloon counterpulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle.

Arrow International, Inc., Division of Teleflex Medical

Class I - Dangerous

The sheath body may become separated from the sheath hub. If the separation occurs, there is a potential for bleeding from the device.

Feb 10, 2016 Other Medical Devices Nationwide View Details →

Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I¿ H/S Cuvette. The cuvette is packaged into Medtronic Perfusion Tubing Packs and only sold as part of the pack. This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass procedures

Medtronic Perfusion Systems

Class I - Dangerous

Medtronic is notifying customers who have or may receive specific lots of Medtronic Perfusion Tubing Packs that include the potentially affected cuvettes manufactured by Terumo Cardiovascular Systems (Terumo CVS). Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I¿ H/S Cuvette. The cuvette is packaged into Medtronic Perfusion Tubing Packs and only sold as part of the pack.

Feb 4, 2016 Other Medical Devices Nationwide View Details →

SENSE Body Coil 1.5T with identification; used in the ACS NT, Intera 1.5T and Achieva 1.5T MR system

Philips Electronics North America

Class I - Dangerous

Wrong positioning of the coil cables can create unintended resonances via the patient or elevated coil cable temperature due to coupling to the QBC. The combined use of the Sense coil, high SAR level scanning and placement of the cables contrary to instructions for use can lead to patient burns.

Jul 6, 2015 Other Medical Devices Nationwide View Details →

BrightView XCT & BrightView XCT Upgrade, gamma cameras; For Single Proton Emission Computed Tomography.

Philips Medical Systems (Cleveland)

Class I - Dangerous

The firm discovered four issues with the BrightView Family systems. Issue 1: During a cardiac non-Auto Body Contouring (ABC) scan, using Cardiac High Resolution (CHR) collimators, the collimator may come in contact with the bottom edge of the patient pallet. If this occurs, collision sensors would pause the scan. Issue 2: During a scan, the gantry motion may halt prematurely. This cause

Dec 17, 2015 Other Medical Devices Nationwide View Details →
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