Medical Devices Recalls
Defective surgical instruments, diagnostic equipment, and health device recalls.
Daig Livewire Steerable, Product Number 401575; REPROCESSED ELECTROPHYSIOLOGY CA...
Incomplete seals on sterile product
Medtronic SynchroMed Flex Infusion Mode - A810 Clinician Programmer Software App...
Software issue: When programming the SynchroMed Pump with the A810 CP App in Flex Infusion Mode, the infusion steps should automatically be arranged in consecutive order, from earliest to latest. However, in rare cases, the steps may be displayed out of order. If this occurs, the programmed Flex Infusion schedule will not be delivered at the intended time, if at all.
Daig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY CA...
Incomplete seals on sterile product
BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY ...
Incomplete seals on sterile product
NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232-SF...
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.
Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, ...
Potential for the bolts and plastic parts of the Cable Hose Carriers that hold the cable hose to the monitor ceiling suspension may loosen and/or break over time due to the forces applied when the monitor is moved or rotated.
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.
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 401652; REPROCESSED ELECTROPHYSIOLOGY CA...
Incomplete seals on sterile product
Namic Preceptor Manifold, custom, Medline Product Number/SKU 64037107; Extravasc...
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-30...
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 Angiographic Manifold, custom, Medline Product Number/SKU 64038200; Cardio...
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Medline medical convenience kits, containing Namic Manifold, Labeled as: 1. M...
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Brand Name: DONJOY Product Name: ICEMAN, W/COLDPAD, NS, RH Model/Catalog Numbe...
Due to broken connector which may result in a temporary interruption of prescribed cold therapy.
BARD Dynamic XT Steerable, Product Number 201104; REPROCESSED ELECTROPHYSIOLOGY ...
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.
1. 3 VALVE MAN KIT, Medline Kit SKU Number: 65101544; 2. 3V MANIFOLD KIT, Med...
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
LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UD...
Due to a subset of chest compression systems/devices where the service performed on the systems were not appropriately documented (The documents for the service performed to justify the passing results were not include in the service records).
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.
Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CA...
Incomplete seals on sterile product
QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococ...
Product has the potential for false positive results
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.
Namic Preceptor Manifold, custom, Medline Product Number/SKU 64039307; Extravasc...
Medline has identified the presence of particulate within the fluid path of the Manifolds.