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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

38,779 Total Recalls

EEA Circular Stapler with Tri-Staple Technology, Part No. TRIEEA28MT TRIEEA28XT TRIEEA31MT TRIEEA31XT Product Usage: The EEA Circular Stapler with Tri-Staple Technology places a circular, triple staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis.

COVIDIEN

Class I - Dangerous

The firm identified the potential for a device to have an incorrect tissue gap. Use of a device with an incorrect tissue gap may result in incomplete staple formation and/or the inability to remove the device from tissue following application potentially leading to bleeding, anastomotic leak or tissue trauma. There have been no reports of serious injury related to this issue.

Aug 17, 2018 Other Medical Devices Nationwide View Details →

CNB200T CONTIPLEX TUOHY SET 2 IN, Material Number 331691 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical

Class I - Dangerous

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Jul 20, 2018 Surgical Instruments Nationwide View Details →

CE18HKST CONT EPID 20G SOFTIP, Material Number 332084 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical

Class I - Dangerous

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Jul 20, 2018 Surgical Instruments Nationwide View Details →

ES1827K SPINAL/EPIDURAL TRAY (LF), Material Number 333192 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical

Class I - Dangerous

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Jul 20, 2018 Surgical Instruments Nationwide View Details →

ES1827KDS SPINAL/EPIDURAL FULL KIT, Material Number 333194 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical

Class I - Dangerous

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Jul 20, 2018 Surgical Instruments Nationwide View Details →

CE18TKO PERIFIX ONE EPIDURAL FULL TRAY, Material Number 332282 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical

Class I - Dangerous

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Jul 20, 2018 Surgical Instruments Nationwide View Details →

CE17TK CONT EPIDURALTUOHY, Material Number 332221 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical

Class I - Dangerous

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Jul 20, 2018 Surgical Instruments Nationwide View Details →

Heart Ware(TM) HVAD(TM) System Controller/Controller Kits, Model Numbers: 1403, 1407, and 1420 Product Usage: The HeartWare HVAD System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a Bridge to Cardiac Transplantation (BTT), myocardial recovery, or as Destination Therapy (DT) in patients for whom subsequent transplantation is not planned.

Heartware

Class I - Dangerous

Certain HVAD System Controller units may not meet the labeled standard for protection against water or fluid ingress, specifically they may have the potential to develop hairline cracks at the power ports of the controller housing.

Aug 28, 2018 Other Medical Devices View Details →

CNB400TU3KUE 18GX4 CONTI THY ULTRA 360, Material Number 332170 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical

Class I - Dangerous

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Jul 20, 2018 Surgical Instruments Nationwide View Details →

ENDOLOGIX AFX/AFX2, Limb (Iliac) Extension Endograft, Rx Only, Sterile EO, AFX Limb Accessory Model #/REF: I16-16/C55, I16-16/C55F, I16-16/C88, I20-13/C70F, I20-13/C88F, I16-16/C55, I16-16/C55F, I16-16/C88, I20-13/C70F, I20-13/C88F; AFX Stand Alone I16-16/C55 SA, I16-16/C55F SA, I16-16/C88 SA, I20-13/C70F SA, I20-13/C88F SA, I20-20/C55 SA, I20-20/C55F SA, IS20-25/C55 SA, IF20-25/C65 SA, IS20-25/C65 SA

Endologix

Class I - Dangerous

Endologix is notifying physicians of patient tailored surveillance recommendations as well as general warnings/precautions for interventions to or through an existing AFX device. This is a follow-up notification to the one that was sent out in December 2016. The updates are related to the observation of Type III endoleaks.

Jul 31, 2018 Other Medical Devices Nationwide View Details →

CE17TKFSA FULL TRAY W/17G TUOHY 19G SPRW, Material Number 332080 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical

Class I - Dangerous

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Jul 20, 2018 Surgical Instruments Nationwide View Details →

CE18TOD CONT EPIDURAL TRAY LF, Material Number 332236 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical

Class I - Dangerous

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Jul 20, 2018 Surgical Instruments Nationwide View Details →

CLAMP STYLE CATH. CONNECTOR 18-19 GA- LF, Material Number 332285 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

B. Braun Medical

Class I - Dangerous

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Jul 20, 2018 Surgical Instruments Nationwide View Details →

Bronchovidescope BF-1T240

Olympus Corporation of the Americas

Class I - Dangerous

The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.

Aug 8, 2018 Other Medical Devices Nationwide View Details →