Medical Devices Recalls
Defective surgical instruments, diagnostic equipment, and health device recalls.
Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33418...
Due to stain present on the surface of affected foley catheters.
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94...
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 GUNDRY Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model...
Certain lots of product have the potential for a sterile barrier breach.
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, Model 94...
Certain lots of product have the potential for a sterile barrier breach.
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 13FR, 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.
Medtronic DLP Retrograde Cannula Manual-Inflate Silicone Body 15FR, Model 94...
Certain lots of product have the potential for a sterile barrier breach.
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.
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.
OneLIF Interbody Cage (REF/Description): 010-107-1007/Small 7 Degree 10mm X 7mm...
Intervertebral body fusion system straight inserter failed to properly attach to affected cages, which may result in an inability to securely engage the implant with the inserter, which could lead to procedural delay and/or the need to select an alternative implant.
Swan-Ganz Pacing Catheter, Models: D200F7;
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.
Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P
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.
Tangent Endoscopy, Tangent Single Use Digital Catheter. Model Numbers: (1) T...
Affected devices exhibited fractures at the distal shaft tip without complete detachment.
Philips Azurion systems not configured with an optional auxiliary pan handle. In...
Potential safety issue with Philips Azurion systems, where longitudinal and transverse table movements may be impacted due to mechanical wear of the Float Tabletop control on the control module.
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.
Cannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-15322-...
16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.
Daig Livewire Steerable, Product Number 401914; REPROCESSED ELECTROPHYSIOLOGY CA...
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.
Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27
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.
Namic Preceptor Manifold, custom, Medline Product Number/SKU 64037107; Extravasc...
Medline has identified the presence of particulate within the fluid path of the Manifolds.
BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOG...
Incomplete seals on sterile product