Medical Devices Recalls
Defective surgical instruments, diagnostic equipment, and health device recalls.
Medtronic GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model...
Certain lots of product have the potential for a sterile barrier breach.
Integris-Allura system; System Code Description (Model Numbers): Integris CV Ces...
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94...
Certain lots of product have the potential for a sterile barrier breach.
Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) T...
Affected devices exhibited fractures at the distal shaft tip without complete detachment.
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94...
Certain lots of product have the potential for a sterile barrier breach.
Swan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6/09...
Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94...
Certain lots of product have the potential for a sterile barrier breach.
Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w/ChemoLock Port, Cla...
Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy this may result in therapy interruption with the potential for the patient to receive less infusion solution than intended. Exposure of hazardous substances to the patient, caregiver, or pharmacy technician is possible.
Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063),...
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.
Allura system; System Code Description (Model Numbers): Allura Xper FD10C (72200...
The deaeration hose in X-ray tube cooling units type CU3101, manufactured between February 2016 and May 2020, may degrade over time, potentially resulting in oil leakage. Oil leakage may affect the cooling performance of the X-ray tube. When the oil flow drops below a certain threshold, the system automatically switches to low-dose fluoroscopy and displays the message Low load fluoroscopy flavor selected: Tube cooler problem . This condition cannot be resolved by restarting the system.
Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY ...
Incomplete seals on sterile product
Medline medical convenience kits, containing Namic Manifold, Labeled as: HEART ...
Medline has identified the presence of particulate within the fluid path of the Manifolds.
BARD Dynamic Tip Steerable, Product Number 6DYNTP001;
Incomplete seals on sterile product
Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexc...
A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flicker through previous EGVs. In more severe instances, the app may perceive signal loss and deploy signal loss mitigations. This delay in EGV and alert processing creates a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information.
Diowave Laser System, REF: Diowave 250W
Software update is needed for laser systems, for topical infrared heating to provide temporary relief of minor muscle and joint pain, spasms, stiffness associated with minor arthritis, and to temporarily increase local blood circulation, operating at a maximum average power output of 70W, which is beyond the FDA cleared 60W.
Daig Livewire Steerable, Product Number 401923; REPROCESSED ELECTROPHYSIOLOGY CA...
Incomplete seals on sterile product
Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6
GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with certain Revolution Apex, Revolution Ascend, and Revolution CT systems.
Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY CA...
Incomplete seals on sterile product
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom...
A software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs) and trend arrows. When the app is running in the background, EGV notifications may queue up and then "replay" sequentially when the user brings the app to the foreground, causing the Glucose Compass to flicker through previous EGVs. In more severe instances, the app may perceive signal loss and deploy signal loss mitigations. This delay in EGV and alert processing creates a risk that users may miss detection of a hypoglycemic or hyperglycemic event, or make treatment decisions based on outdated glucose information.
Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
Labeling update to provide warning if functionality of the valve replacement delivery system is compromised.
LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWork...
Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorrect device configuration. If device is oversized may lead to increased vessel wall stress, neointimal hyperplasia, vessel injury/rupture; if undersized may lead to incomplete expansion/malposition, acute stent thrombosis, distal embolization, ischemic neurological events
Daig Livewire Steerable, Product Number 401603, REPROCESSED ELECTROPHYSIOLOGY CA...
Incomplete seals on sterile product