Medical Devices Recalls
Defective surgical instruments, diagnostic equipment, and health device recalls.
Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide ...
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ...
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.H1; drills, b...
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom...
Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process. The sensors were later sold to pharmacies and distributors by Pharmsource, LLC. Lot 1725204004 were designated for destruction because the G7 sensors were not properly sterilized and have an increased risk of skin infection if used. Lot 1725069002 were designated for destruction due to an increased risk of having no sensor readings available or experiencing sensor inaccuracy that includes the potential for missed detection of a hyperglycemic event or incorrect treatment decisions that can result in patient injury, including medical intervention to prevent permanent injury or impairment. Additionally, due to the unknown storage and handling and storage conditions these sensors may have undergone during the distribution, these sensors may present additional risk.
Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14...
Potential for thrombus formation during prolonged use of the introducer.
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ...
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Surgify Halo, 4.0 mm, Short, Model/Catalog Number: 40.070.NVG.U1; drills, burrs,...
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System
GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches an interactive application (e.g. Volume Viewer), the application may open the previous patient's exam instead of the intended one. When this issue occurs, there is no system warning or error notification. If the error is not recognized, a clinical user could review, interpret, or report images for the wrong patient which could lead to misdiagnosis, incorrect clinical decisions, resulting in delayed or incorrect treatment.
Surgify Halo, 5.4 mm, Long, Model/Catalog Number: 54.125.NVG.H1; drills, burrs, ...
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide, Model/Catalog Nu...
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
INZONE DETACHMENT SYSTEM, REF: M00345100950
Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual indicators; 3) Be unable to detach a coil as intended, which may necessitate medical intervention if the procedure must be completed with an alternative technique.
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ...
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Octopus 4 Tissue Stabilizer, Model 29400
During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
Surgify Halo, 5.4 mm, Short, Model/Catalog Number: 54.070.NVG.H1; drills, burrs,...
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Pro...
Potential for thrombus formation during prolonged use of the introducer.
Surgify Halo, 3.0 mm, Long, Model/Catalog Number: 30.125.NVG.U2; drills, burrs, ...
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310
A snare catheter including luer lock, indicated for removal or manipulation of a foreign body in the vascular system, failed to meet the biocompatibility requirements for in-vitro-cytotoxicity, which if in contact with a patient's vasculature could result in localized inflammation and tissue irritation.
Surgify Halo, 4.0 mm, Extendable, Model/Catalog Number: 40.000.SEE.U1; drills, b...
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ...
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Octopus Evolution Tissue Stabilizer, Model TS2000
During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ...
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Surgify Halo, 3.0 mm, Short, Model/Catalog Number: 30.070.NVG.U2; drills, burrs,...
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephi...
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ...
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.