FDA Class 1 recall alert-Arrow International Intra-Aortic Balloons

April 17, 2009
3:00 am

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Heather L. Ryan, R.N., C.L.N.C- Heather Ryan is a Certified Legal Nurse Consultant with 15 years of experience in the health care industry. Her expertise in reviewing medical records and assisting lawyers with the determination as to whether legal action should be taken provides an invaluable asset to the newsroom. Medical-malpractice, products liability, personal injury and workers’ compensation are some of the recent areas of litigation Ms. Ryan has focused her efforts on. A member of the Florida Justice Association, Heather maintains a long list of certifications and credentials to support her areas of expertise and stays up-to-date with her clinical knowledge working as an emergency room/trauma nurse, at a Level 1, Adult/Pediatric trauma and teaching institution in South Florida.

FDA Class 1 recall alert-Arrow International Intra-Aortic Balloons

Arrow International updates recall of defective critical care heart product.

New York, NY (JusticeNewsFlash.com)–Everett, Massachusetts based medical device manufacturer, Teleflex Medical-Arrow International, in cooperation with the U.S. Food and Drug Administration (FDA) www.fda.gov has updated its Class 1 recall alert. According to the medical product maker, reports from doctors, nurses and other health care professionals claim Arrow International Inc. 30, 40, and 50 cc Intra-Aortic Balloons have a faulty connector to the pump tubing assembly.

Intra-Aortic Balloons are part of the Intra-Aortic Pump System designed to provide cardiac assist therapy to critically ill patients to increase blood flow to the heart. The defective product may fail and result in the volume setting on the pump to default to 2.5 ccs or 5 ccs (depending on the Intra-Aortic Balloon Pump model) rather than the appropriate 30, 40, or 50 cc volume. This can be catastrophic to an injured heart patient and cause rapid decline in physical function and result in the immediate death.

According to the FDA, a Class 1 recall is the most serious alert federal regulators can order citing the defective product can cause serious injury including death. Healthcare professionals, family members of critically ill heart patients, and American consumers may consult the FDA website for a complete and updated list of the defective product numbers and their manufacturing dates. Defective medical products may causes serious injuries, life-threatening events and even death to consumers.

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