March 20, 2024Medical DevicesFDA
Medos International Sarl recalls CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular guide-cathe
Hazard: Medos has received an increase in complaints for CEREBASE DA Guide Sheath with reports of fractures at the distal end, which may result in surgical procedural delay, vascular injury and in extreme rare occasions it may result in embolism.
March 20, 2024Medical DevicesFDA
Fresenius Kabi USA, LLC recalls LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
Hazard: Retroactively reported corrections from 2023: 1) A software defect may cause an incorrect (Fail-Stop) alarm when an administration set is loaded or coupled while the pump is executing the power-up sequence. May lead to delay in therapy. 2) Alert is not annunciated informing the clinician that the bolus cannot be delivered when the entered bolus dose exceeds the Care Profile Hard Rate Max limit and Rapid Bolus is selected. May lead to over infusion. Both issues were resolved in all fielded product in software version 5.8.0, which was installed in affected units May thru August 2023.
March 20, 2024Medical DevicesFDA
Fresenius Kabi USA, LLC recalls LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
Hazard: Retroactively reported correction from 2022: A software defect may cause an incorrect (Fail-Stop) Alarm when an administration set is loaded with an upstream occlusion present, resulting in a non-recoverable (Fail-Stop) Pump Problem alarm. This may lead to delay of therapy, and patient may experience from no to minimal to serious harm. This issue was resolved in all fielded product in software version 5.2.1, which was installed in September 2022.
March 20, 2024Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls ADVIA Centaur Erythropoietin (EPO) Assay (100 Test)
Hazard: Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World Health Organization (WHO) International Standard (NIBSC code: 11/170) that is proportional across the assay measuring interval. The reference interval as claimed in the Instructions for Use (IFU) is not achieved with affected lots.
March 20, 2024Medical DevicesFDA
Siemens Healthcare Diagnostics, Inc. recalls Atellica IM Erythropoietin (EPO) Assay (100 Test)
Hazard: Siemens Healthcare Diagnostics has confirmed an average negative bias of -35% compared to the 3rd World Health Organization (WHO) International Standard (NIBSC code: 11/170) that is proportional across the assay measuring interval. The reference interval as claimed in the Instructions for Use (IFU) is not achieved with affected lots.
March 20, 2024Medical DevicesFDA
Peter Lazic Gmbh recalls D-Clip Standard/Mini Applier, 230mm bayonet, jaw rigid, double action.
Hazard: Customer complaint received that reported the applier failed during surgery. The applier did not release the clip. The applier remained attached to the clip.
March 20, 2024Medical DevicesFDA
Peter Lazic Gmbh recalls D-Clip Standard/Mini Applier, 210mm bayonet, jaw rigid, double action.
Hazard: Customer complaint received that reported the applier failed during surgery. The applier did not release the clip. The applier remained attached to the clip.
March 20, 2024Medical DevicesFDA
Peter Lazic Gmbh recalls D-Clip Standard/Mini Applier, 190mm bayonet, jaw rigid, double action.
Hazard: Customer complaint received that reported the applier failed during surgery. The applier did not release the clip. The applier remained attached to the clip.
March 13, 2024Medical DevicesFDA
ConvaTec, Inc recalls ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.
Hazard: The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring.
March 13, 2024Medical DevicesFDA
FUJIFILM Healthcare Americas Corporation recalls Synapse PACS - Version 7.3.000
Hazard: Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.
March 13, 2024Medical DevicesFDA
FUJIFILM Healthcare Americas Corporation recalls Synapse PACS - Version 7.2.200
Hazard: Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.
March 13, 2024Medical DevicesFDA
FUJIFILM Healthcare Americas Corporation recalls Synapse PACS - Version 7.2.100
Hazard: Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.
March 13, 2024Medical DevicesFDA
FUJIFILM Healthcare Americas Corporation recalls Synapse PACS - Version 7.2.000
Hazard: Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.
March 13, 2024Medical DevicesFDA
FUJIFILM Healthcare Americas Corporation recalls Synapse PACS - Version 7.1.000US
Hazard: Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.
March 13, 2024Medical DevicesFDA
FUJIFILM Healthcare Americas Corporation recalls Synapse PACS - Version 7.1.000
Hazard: Measurements on a Secondary Capture 2D image, that does not have pixel spacing in the DICOM header, when combined with a Breast Tomo Series results in incorrect measurements.
March 13, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
Hazard: Potential packaging breaches of inner blister and outer sterile blister.
March 13, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM
Hazard: Potential packaging breaches of inner blister and outer sterile blister.
March 13, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
Hazard: Potential packaging breaches of inner blister and outer sterile blister.
March 13, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
Hazard: Potential packaging breaches of inner blister and outer sterile blister.
March 13, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls X3 TRIATHLON CS INSERT NO 7 9 MM
Hazard: Potential packaging breaches of inner blister and outer sterile blister.
March 13, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls X3 TRIATHLON CS INSERT NO 6 11 MM
Hazard: Potential packaging breaches of inner blister and outer sterile blister.
March 13, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls X3 TRIATHLON CS INSERT NO 6 10 MM
Hazard: Potential packaging breaches of inner blister and outer sterile blister.
March 13, 2024Medical DevicesFDA
Howmedica Osteonics Corp. recalls X3 TRIATHLON CS INSERT NO 3 10 MM
Hazard: Potential packaging breaches of inner blister and outer sterile blister.
March 13, 2024Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Embrace Drill Tower, Standard/Lateral (25mm)
Hazard: The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview of the instruments.
March 13, 2024Medical DevicesFDA
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Embrace Drill Tower, Wedged (25mm)
Hazard: The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview of the instruments.
March 13, 2024Medical DevicesFDA
Paragon 28, Inc. recalls Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R
Hazard: Medical devices distributed, prior to sterilization
March 13, 2024Medical DevicesFDA
Paragon 28, Inc. recalls Phantom TTC Nail, TTC Nail, 10.0 X 150mm, RIGHT , REF: P31-600-175L
Hazard: Medical devices distributed, prior to sterilization
March 13, 2024Medical DevicesFDA
Paragon 28, Inc. recalls Phantom TTC Nail, 10.0 X 200mm, Right
Hazard: Medical devices distributed, prior to sterilization
March 13, 2024Medical DevicesFDA
Micro Therapeutics, Inc. recalls The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed for the inf
Hazard: European version of microcatheter were distributed within US which contain a different "Indications for Use".
March 13, 2024Medical DevicesFDA
Micro Therapeutics, Inc. recalls The Apollo Onyx Delivery Microcatheter (AOMC) is a DMSO-compatible, single-lumen, end hole catheter designed for the inf
Hazard: European version of microcatheter were distributed within US which contain a different "Indications for Use".