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Medical Device Safety

Update – November 21, 2024

CDRH is announcing a communications pilot to enhance the medical device recall program and to improve the timeliness of communications about corrective actions being taken by companies that the FDA believes are likely to be high-risk recalls. The pilot will include early alerts of potentially high-risk device removals or corrections related to cardiovascular, gastrorenal, general hospital, obstetrics and gynecology, and urology. This pilot follows the commitments noted in our 2024 Safety Report and recommendations from the Patient Engagement Advisory Committee, to enhance our medical device recall program.

The FDA monitors reports of adverse events and other problems with medical devices and when needed, alerts patients, health care providers, industry, and the public. The lists below contain our most recent information. For additional information, contact us – Division of Industry and Consumer Education (DICE).

Recent Medical Device Safety Communications

The FDA's analyses and recommendations for patients and health care providers about ongoing medical device safety issues.

FDA Safety Communication Publish Date
Accolade Pacemaker Devices by Boston Scientific and Potential Need for Early Device Replacement - FDA Safety Communication
Mga May Kaugnayang Recall - Mga Plastik na Hiringgilya na Gawa sa China para sa Mga Potensyal na Pagpalya ng Device
相关召回——中国制造的塑料注射器存在潜在器械故障
Retiros relacionados: jeringas de plástico fabricadas en China para detectar posibles fallas en los dispositivos
Zimmer Biomet CPT Hip System Femoral Stem at Nadagdagang Panganib ng Bali sa Buto sa May Hita - Komunikasyong Pangkaligtasan ng FDA
Zimmer Biomet CPT 髋关节系统股骨柄可能增加大腿骨骨折风险——美国食品药品监督管理局 (FDA) 安全通报
Vástago femoral del sistema de cadera CPT de Zimmer Biomet y mayor riesgo de fracturas del fémur: Comunicado de seguridad de la FDA

MORE MEDICAL DEVICE SAFETY COMMUNICATIONS

Recent Letters to Health Care Providers

Information for health care providers about the safe use of medical devices in medical facilities.

Device Name Publish Date
Safety and Availability Concerns with VasoView HemoPro Endoscopic Vessel Harvesting Systems - Letter to Health Care Providers

MORE LETTERS TO HEALTH CARE PROVIDERS

Recent Medical Device Recalls and Early Alerts

Medical device recalls that may potentially present significant risks. Note that Early Alerts, as part of a pilot, include information on actions being taken by companies that the FDA believes are likely to be the most serious type of recall, but where the FDA may not yet have determined that the actions meet the regulatory definition of a recall. These actions may include when companies remove products from the market, correct products, or update instructions for using products due to potentially high safety risks.

Device Name Publish Date
Early Alert: Nephroscope Sheath Issue from Trokamed GmbH
Catheter Correction: Boston Scientific Updates Use Instructions for POLARx and POLARx FIT Cryoablation Balloon Catheters due to Higher than Anticipated Number of Reports of Atrio-Esophageal Fistula
Implantable Marker Recall: Hologic Removes BioZorb 3D Bioabsorbable Markers due to Risk for Patient Complications
Early Alert: Infusion Pump Issue from Fresenius Kabi USA
Neonatal Incubator Correction: GE HealthCare Updates Use Instructions for GE HealthCare Giraffe OmniBed Carestation and Incubator Carestation due to Risk of Patient Formaldehyde Exposure
Syringe Recall: Cardinal Health Removes Certain Monoject U-100 mL Insulin Syringe Luer Lock with Tip Cap Soft Packs due to Incompatibility with Needleless Connectors
Hemodialysis Correction: Baxter Issues Correction for AK 98 Hemodialysis Machines Due to Risk of Patient Exposure to Higher Than Allowable Levels of Toxic Compound NDL-PCBA and/or NDL-PCBs
Peritoneal Dialysis Set Correction: Baxter Issues Correction for MiniCap Extended Life Peritoneal Dialysis Transfer Sets Due to Risk of Patient Exposure to Higher Than Allowable Levels of Toxic Compound NDL-PCBA and/or NDL-PCBs
Insertion Tube Recall: FHC Removes microTargeting Insertion Tube Sets due to a Manufacturing Size Error That May Lead to Patient Harm
Biopsy Needle Recall: Elekta Removes Disposable Biopsy Needle Kits due to Risk of Microscopic Stainless Steel Debris Inside Needle
Anesthesia Machine Correction: Draeger, Inc., Issues Correction for Atlan A350 and A350 XL Anesthesia Workstations Due to Possible Mechanical Ventilation Failure
Ventilator Correction: Philips Updates Use Instructions for Trilogy Evo, EvoO2, EV300, Evo Universal, Aeris EVO, Garbin Evo, and LifeVent EVO2 due to Risk of Inaccurate Flow Measurements Caused By Certain In-Line Nebulizer Placements
Battery Pack Correction: Smiths Medical Updates Use Instructions for CADD-Solis Li-ion Rechargeable Battery Packs Due to Risk That Pack Damage May Cause a Circuit Short and Prevent Recharge
Endoscopic Vessel Harvesting System Recall: Getinge and Maquet Cardiovascular Remove VasoView HemoPro 1 and 1.5 Endoscopic Vessel
IPV Therapy Device Recall: Percussionaire Removes Certain Phasitron 5 Breathing Circuits Due to Risk of Nickel Exposure
Incubator/Warmer Correction: GE Healthcare Updates Use Instructions for Giraffe OmniBed and Giraffe Omnibed CareStation due to Risk of Heater Door Falling and Causing Infant Injury
Assistive Arm Correction: Kinova Issues Correction for Jaco Assistive Robotic Arm due to Fire Hazard and Burn Risk
Tracheostomy Tube Recall: Smiths Medical Removes BLUselect, BLUgriggs, and BLUperc Tracheostomy Tube Kits due to Potential Disconnection of Pilot Balloon
Insulin Pump Recall: Medtronic Notifies Users of MiniMed 600 and 700 Series Pumps of Risk of Shorter than Expected Battery Life
Infusion Pump Recall: Zyno Medical Removes Z-800, Z-800F, Z-800W, and Z800WF Infusion Pumps due to an Air-in-Line Software Defect That May Allow Larger than Expected Air Bubbles to Enter Patients
Resuscitator Recall: Mercury Medical Removes Neo-Tee T-Piece Resuscitators due to Risk of Inline Controller Detachment that May Impact Ventilation
IPV Therapy Device Correction: Sentec/Percussionaire Updates Use Instructions for Phasitron 5 In-Line Valve to Prevent Accidental Misuse of Expiratory Port Plug
Ventilator Software Correction: Philips Respironics Issues Mandatory Software Correction and Updates Use Instructions for Trilogy Evo, EV300, EvoO2, and Evo Universal to Address Multiple Issues that May Impact Ventilation
Infusion Pump Software Correction: Fresenius Kabi USA, LLC, Issues Correction for Ivenix Infusion System Large Volume Pump (LVP) Software due to Multiple Anomalies that May Cause Delay or Underdosage of Therapy
Ventilator Correction: Smiths Medical Issues Correction for paraPAC Plus P300 and P310 Ventilators due to Inadvertent Tidal Volume Knob Movement

MORE MEDICAL DEVICE RECALLS AND EARLY ALERTS

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