Medical Devices Recalls
Defective surgical instruments, diagnostic equipment, and health device recalls.
EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.
Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci ...
Due to a software implementation error that allowed instruments arms failing an important diagnostic test to remain in clinical use. This test was supposed to be used to detect Universal Surgical Manipulator insertion axis ball screws that exhibit the symptoms of being bent and misaligned which is a precursor to potential ball screw fatigue failure/fraction
MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Ve...
A software timing and processor communication issue in MiniMed" 780G software version 6.60 may trigger Pump Error 43 and/or Pump Error 41, resulting in suspension of insulin delivery.
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Ca...
Devices which did not undergo thermoforming could deform and lose performance.
Product Name: Nasal Jejunal Feeding Tube REF: NJFT-10
Nasal feeding tube packaged without the nasal transfer tube component.
NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syn...
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Product Name: Single Use Sphincterotome V (Distal Wire guided) Model/Catalog Nu...
Devices which did not undergo thermoforming could deform and lose performance.
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411...
Devices which did not undergo thermoforming could deform and lose performance.
Vortex Surgical I2 Injection Kit, VS0500
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Brand Name: Molift Product Name: Molift 2-point sling bars (Accessory to mobile...
A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this customer complaint, it became clear that the defect occurs as a result of deformation of the materials involved between the lifting bar and the arm of the device. Such deformation can lead to limited mobility in the joint, which prevents proper functionality of the equipment.
*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Mater...
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.
Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;
Internal investigations have identified an issue with the durability of the connecting cable near the connection to the Venous Bubble Sensor. Excessive bending of the connecting cable can lead to full damage of the Venous Bubble Sensor or loose cable contact, which may trigger the errors Ven. bubble sensor defective or Ven. bubble sensor disconnected on the connected medical device. These errors can occur temporarily when the connecting cable is moved or permanently if the connection is fully compromised.
Menopause Test Cassette (Urine)
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
PRISMAFLEX ST100 SET US, Product Code 107636US; Dialyzer, High Permeability With...
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
LH One Step Ovulation Test Device (Urine)
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-4...
Devices which did not undergo thermoforming could deform and lose performance.
Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Model/Catal...
Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V41...
Devices which did not undergo thermoforming could deform and lose performance.
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V43...
Devices which did not undergo thermoforming could deform and lose performance.
Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges Mod...
Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).
VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ce...
Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aeruginosa with the identified antibiotic formulations. Issue may lead to QC failure or false resistant results.
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V41...
Devices which did not undergo thermoforming could deform and lose performance.
TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ3...
A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual screws are 5.00mmx14mm. If mismatch is detected during surgery, the issue may cause a minor delay in surgery. If not detected and incorrect screw is used, issue may increase risk of earlier mechanical failure, loosening, and need for revision surgery.
AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Material N...
Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.