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Ohio Dangerous Drugs and Medical Devices

Infant Warmers Urgently Recalled due to Falling Risk

By Heidi Culbertson

Baby

Infant Warmers Urgently Recalled due to Falling Risk On July 12, 2019, the U.S. Food and Drug Administration (“FDA”) announced the Class I recall of GE Healthcare’s Giraffe and Panda i-Res Infant Warmers after GE received reports of infants suffering injuries, including fractured skulls, associated with the warmers. A Class I recall is the FDA’s… Read more »

Millions of Medical Device Injuries and Malfunctions Hidden from the Public

By Heidi Culbertson

Medical Devices

By Jessica L. Powell, Burg Simpson Associate Millions of Medical Device Injuries and Malfunctions Hidden from the Public  5.7 million reports of device injuries and malfunctions were hidden from the public, according to Kaiser Health News. Medical device manufacturers are required to notify the FDA about certain device injuries and malfunctions, called “adverse events.” Generally,… Read more »

Multiple Drops/Medications for the Eyes Recalled due to Sterility Concerns

By Burg Simpson

On July 3, 2019, the FDA announced that Altaire Pharmaceuticals voluntarily recalled certain eye drops, eye lubricants, and prescription eye ointments sold over the counter under the Walgreens brand name, as well as some prescription products. According to the FDA, Altaire initiated the recall “due to management concerns regarding the sufficiency of Quality Assurance controls… Read more »

Recall of IntraClude Device Used In Patients Undergoing Cardiopulmonary Bypass

By Burg Simpson

Cardio Image

By Melanie S. Bailey, Burg Simpson Shareholder Recall of IntraClude Device Used In Patients Undergoing Cardiopulmonary Bypass Edwards Lifesciences has issued a Class I recall of its IntraClude Intra-Aortic Occlusion Device used in patients undergoing cardiopulmonary bypass.  Cardiopulmonary bypass machines are used to temporarily take over the function of the heart and lungs during surgery. … Read more »

Balloon Catheter Recalled due to Bursting.

By Burg Simpson

Balloon Catheter Recalled due to Bursting. On June 18, 2019, the FDA reported that Cook Incorporated has recalled a balloon catheter, the Advance Enforcer 35 Focal-Force PTA Balloon Catheter 6mm x 4cm.  This catheter is used to open blocked or narrowed arteries that supply blood to the leg. What are balloon catheters? Balloon catheters are… Read more »

TERUMO MEDICAL RECALLS SURGICAL DEVICES OUT OF FEAR OF VASCULAR DAMAGE, EVEN DEATH

By Heidi Culbertson

TERUMO MEDICAL RECALLS SURGICAL DEVICES OUT OF FEAR OF VASCULAR DAMAGE, EVEN DEATH On April 26, 2019, Terumo Medical Corporation voluntarily recalled two of its surgical devices, the SoloPath Balloon Expandable TransFemoral Introducer System (STFI) and the SoloPath Re-Collapsible Access System (SR). Both devices were designed to help surgeons safely and easily introduce and/or guide… Read more »

Fire Concerns Prompt Recall of Edwards Lifesciences’ Hospital Bedside Monitoring Systems

By Burg Simpson

Medical Chart

By John Roberts, Burg Simpson Associate Fire Concerns Prompt Recall of Edwards Lifesciences’ Hospital Bedside Monitoring Systems  On March 21, 2019, Edwards Lifesciences LLC initiated a recall of its EV1000 clinical platforms. “Clinical platforms” are best characterized as the bedside computer system used to monitor a patient’s pulse and blood pressure both during and after… Read more »

Ethicon Recalls Surgical Staplers.

By Burg Simpson

Ethicon Recalls Surgical Staplers On April 11, 2019, Ethicon, a subsidiary of Johnson & Johnson, issued a recall of it intraluminal surgical staplers.  The surgical staplers are used in gastrointestinal tract surgeries to fire staples to create connections between structures (anastomoses).  The Ethicon surgical staplers may have been used in patients who have undergone gastrointestinal… Read more »

Burg Simpson Files Lawsuit Against Endologix For Failed AFX AAA Device

By Burg Simpson

Surgery

By Kenneth M. Daly, Burg Simpson Associate Burg Simpson Files Complaint Against Endologix For Failed AFX AAA Device On April 29, 2019, Burg Simpson filed a products liability lawsuit against Endologix, Inc. (Endologix) regarding its AFX Endovascular AAA System used to repair abdominal aortic aneurysms. Plaintiff alleges, that as the result of a failed AFX… Read more »

Cook Medical Recalls Dangerous Transseptal Needle

By Burg Simpson

By David C. Harman, Burg Simpson Shareholder Cook Medical Recalls Dangerous Transseptal Needle On March 13, 2019, The U.S. Food and Drug Administration (FDA) announced that Cook Medical Inc. sent an urgent recall notification letter to affected customers regarding its Transseptal Needle. Cook Medical’s Transseptal Needle is a surgical device used to gain access to… Read more »

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