AUDIENCE: Physical Medicine, Orthopedics, Consumer ISSUE: FDA notified health professionals and consumers of serious health risks posed by the ShoulderFlex Massager. FDA is aware of reports to the Consumer Product Safety Commission of one death and one near-strangulation associated with the ShoulderFlex Massager. These incidents occurred when a necklace and clothing became caught in a […]
H & #38; P Industries Povidone Iodine Swabsticks, Prep Solutions, Scrub Solutions, and Prep Gel: Recall – Inadequate Microbial Testing
Multiple brands affected – listed below AUDIENCE: Pharmacy, Consumer, Risk Manager ISSUE: H & P Industries and FDA notified health professionals and the public of a recall of all lots (lots beginning with 8J-8M, 9A-9M, 0A-0M, 1A-1C) of Povidone Iodine Swabsticks, Prep Solutions, Scrub Solutions, and Prep Gel. H & P Industries, Inc. manufactured […]
Boston Scientific Innova Self-Expanding Stent System: Recall – Failure to Deploy
AUDIENCE: Interventional Radiology, Risk Manager ISSUE: Complaints of no deployment and partial deployment have been received. This type of failure may result in vessel wall injury, increased procedure time and/or emergency surgery to remove the partially deployed stent. This recall does not affect stents that have already been implanted as the issue occurs during delivery […]
Boston Scientific iCross and Atlantis SR Pro 2 Coronary Imaging Catheters: Recall – Catheter Tip Can Break Inside of the Patient
Posted 06/14/2011] AUDIENCE: Cardiology, Surgery ISSUE: The catheter tip can break inside of the patient and embolize causing tissue and blood vessel injury, heart attack or other serious events requiring additional unplanned surgery. BACKGROUND: The Boston Scientific iCross and Atlantis A SR Pro2 coronary imaging catheters are intended for ultrasound examination of coronary intravascular pathology […]
Thermographic Imaging Systems for Breast Cancer Screening: FDA Safety Communication
[06/02/2011 – News Release – FDA] [06/02/2011 – Consumer Update – Thermogram No Substitute for Mammogram – FDA] [03/09/2010 – National Cancer Institute – Breast Cancer Screening – NIH] [06/02/2011 – Women’s Health Topics: Mammography – FDA] SOURCE
Axxent FlexiShield Mini by iCAD (formerly Xoft Inc.): Recall- Product May Shed Particles of Tungsten
AUDIENCE: Risk Manager, Radiology, Surgery ISSUE: Xoft Axxent Flexishield Mini product, Model 5300, may shed particles of tungsten. After use during Intraoperative Radiation Therapy (IORT) for in breast tissue, these particles can be mistaken for suspicious calcifications during follow up X-rays or scans. After laboratory testing and a comprehensive literature review, Xoft has concluded that […]
Penumbra Coil 400 by Penumbra Inc.: Class 1 Recall – Premature Detachment of the Coil
AUDIENCE: Risk Managers, Surgery, Emergency Medicine ISSUE: The Penumbra Coil 400 system includes a tool used to implant the coils inside a patient. The pull wire on the delivery tool can slip out of place and allow premature detachment of the coil. Premature detachment of the coil may cause the coil to unintentionally migrate. This […]
Roche ACCU-CHEK FlexLink Plus Infusion Set: Class I Recall – Potential for Under-Delivery of Insulin
AUDIENCE: Endocrinology, Patients ISSUE: There is a potential for under-delivery of insulin due to a tube (cannula) which may become kinked or bent when inserting the ACCU-CHEK FlexLink Plus infusion set. If this remains unnoticed, this can result in under-delivery or no delivery of insulin. This can lead to elevated blood glucose levels (hyperglycemia). Hyperglycemia […]
Mikro-Tip Angiographic Catheter, Model SPC-454D and SPC-454F by Millar Instruments Inc.: Class 1 Recall
AUDIENCE: Risk Manager, Radiology, Cardiology ISSUE: Millar Instruments, Inc, and FDA issued a recall of Human Use High Injection Angiographic Catheter, Models SPC-454D and SPC-454F. There is a possibility that small particles (debris) may be found inside the catheter. This foreign debris can potentially travel (embolize) from the catheter to tissues, blood vessels, limbs and […]
Heartstring II Proximal Seal System (HS-1045) by Maquet Cardiovascular, LLC: Recall – Insufficient Adhesive
AUDIENCE: Risk Manager, Cardiology, Surgery ISSUE: The deployment tube may detach during use due to insufficient adhesive and may result in the failure of the product to operate. This may cause serious injury and/or death. BACKGROUND: This device is used by cardiac surgeons during coronary artery bypass procedures (CABG). It helps to control the flow […]