Class I - Dangerous
There is a potential to leak from the catheter where it connects to the drain bag
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Surgical Instruments
🏥 Medical Devices • 7,015 recalls
Class I - Dangerous
May shed contaminant particles into the urine specimen that may be misidentified as Red Blood Cells when used in conjunction with the Sysmex UF-1000i or UX-2000 Analyzers and lead to false elevations in RBC counts
The firm received reports indicating PTD tip separation during use.
The firm received reports indicating PTD tip separation during use.
The firm received reports indicating PTD tip separation during use.
Class I - Dangerous
The firm received reports indicating PTD tip separation during use.
The firm received reports indicating PTD tip separation during use.
The firm received reports indicating PTD tip separation during use.
The firm received reports indicating PTD tip separation during use.
Class I - Dangerous
There have been intermittent issues with Supercap POST (power on self-test) and Backup Audible Alarm error codes outside of the pump warranty period. These alarms occur at start up when the pump goes through the self-test. This recall occurred in 2015.
Top cap may loosen and detach if the Universal Chuck becomes jammed and the user attempts to manually free the device, internal ball bearings may fall out onto the surgical field and cause surgical delay or, and if not recovered, adverse tissue reaction and infection.
Class I - Dangerous
Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process
Class I - Dangerous
The firm has received six (6) complaint reports from customers indicating difficulty removing the balloon protector sleeve from the catheter (e.g., excessive force required to remove the protector sleeve). If the balloon is damaged while removing the protector sleeve and the catheter is subsequently used in a patient procedure, patient harm may potentially occur, including perforation of vessels, foreign body in patient, embolism, risks associated with surgical intervention, or delay to treatment/therapy.
Class I - Dangerous
The firm is reinforcing the IFU instructions: "Do not use if the package is damaged." If upon inspection of the packaging, any damage is observed, including pinholes or tears in the pouch, the product should not be used.
Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.
Reports have been received of tip damage during use of the devices which resulted in some instances of tip detachment and embolization.
Disposable Subdermal Needle Electrode, Corkscrew, Single Use, Sterile; Model Numbers TE/S50715-001-C, TE/S50725-001C, and TE/S50715-001.
Technomed Europe
Class I - Dangerous
There is a high risk of the blue hub detaching from the corkscrew needle, resulting the the needle remaining in the patient's scalp.
Class I - Dangerous
Issue was identified during internal engineering evaluation. Use of the system with the affected software version may experience either an inability to deliver energy or an inadvertent delivery of energy. Use may require surgeon to resolve an injury or need moderate intraoperative intervention. Also, use may potentially cause user frustration or a minor delay to troubleshoot.
VirtuTRAX Instrument Navigator, 14 Ga VirtuTRAX
Civco Medical Instruments Co.
Class I - Dangerous
There is potential that the VirtuTRAX device will not tighten onto the instrument to be used.
Stealth Autoguide Tracker, Model: 28248, which is an instrument in the Stealth Autoguide Basic Instrument Kit, Mode: 9736188, and the Bundle Autoguide Reg Kit.
Medtronic Navigation
Class I - Dangerous
A tracker that holds and guides neurosurgical surgical instruments may be subject to separation/weld failure, where the tracker connects to the instrument tube. If a weld separation occurs and a navigation inaccuracy is experienced, it may result in prolonged procedure and tissue injury. Per 11/24/21 firm email: The Bundle Autoguide Reg Kit does not have a model number. The Bundle Autoguide Reg Kit is internal terminology and not visible to the customer and are used as sales and shipping configuration only. When this sales bundle is chosen by an internal Medtronic Sales Representative the devices included in the bundle are individually packaged and labeled and sent to the customer in a single shipment. The devices included in the bundle are ordered, packed, and shipped as individual medical devices with unique model numbers, which is the reason that the Autoguide Tracker (28248) and the Stealth Autoguide Basic Instrument Kit (9736188) are the only part numbers subject to this FCA.