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FDA Warns about Opioids, Vascular Patch and Catheter Guides

Closeup of surgeon hands operating

In the last few weeks, the U.S. Food and Drug Administration tackled a number of drug and device warnings and recalls. These include prescription opioid products, the Vascu-Guard patch used in carotid artery surgery and the Roadrunner UniGlide wire guide. In these safety communications, the FDA outlined its actions and recommendations.

FDA Adds Stronger Warning to Opioid Medicines

After the FDA reviewed the latest studies on opioids, the agency is requiring new labels that warn healthcare providers and patients of the serious risks with combined use of opioids and benzodiazepines.

In an August 2016 news release, the FDA said it was adding boxed warnings — the strongest warning — for nearly 400 opioid painkillers, opioid-containing cough medicines and benzodiazepines. Some pain medications in the opioid class include oxycodone, hydrocodone and morphine. Doctors prescribe benzodiazepines for conditions such as anxiety, insomnia seizure disorders.

Some of the risks associated with combined drug use include:

  • Extreme sleepiness
  • Coma
  • Death
  • Respiratory depression

“It is nothing short of a public health crisis when you see a substantial increase of avoidable overdose and death related to two widely used drug classes being taken together,” said FDA Commissioner Robert Califf in the agency’s press release. “We implore health care professionals to heed these new warnings and more carefully and thoroughly evaluate, on a patient-by-patient basis, whether the benefits of using opioids and benzodiazepines – or CNS depressants more generally – together outweigh these serious risks.”

The FDA’s action comes after it received a citizen petition from numerous local and state public health officials and other stakeholders in February 2016. The petition asked the FDA to make changes to the existing labeling for benzodiazepines and opioids painkillers.

Multiple Adverse Events Associated with Vascu-Guard Patch

On September 1, 2016, the FDA reported it received multiple reports of severe bleeding and hematomas associated with the Vascu-Guard Peripheral Vascular Patch made by Baxter International, Inc. Adverse event reports included three deaths.

“The FDA is concerned that the Vascu-Guard patch may not be performing as intended and that patients who are treated with the product may be at risk for serious adverse health consequences, such as severe bleeding, hematomas, and death,” the FDA said on its website. “After CEA surgery in particular, arterial bleeding in the neck could rapidly lead to airway obstruction, hypoxia, diminished brain perfusion, stroke and/or cardiac arrest.”

Doctors use the Vascular Patch to construct blood vessels damaged by Type 2 diabetes, aneurysms, peripheral artery disease and other conditions. The agency recommends that health care professionals discuss all treatment options with patients and watch for bleeding after surgery.

Cook Roadrunner UniGlide Global Recall

On June 24, 2016, Cook Medical issued a recall for its Roadrunner UniGlide Hydrophilic Wire Guide. The FDA classified it a Class I recall — the most serious type of recall that can involve serious injury and death. Doctors use the Roadrunner UniGlide to insert catheters into veins and arteries not located in the chest and abdomen.

In the U.S., the recall includes 8,750 devices distributed between May 2, 2016 and June 17, 2016.

Cook recalled the devices because certain lots may contain glass particles. Potential adverse events include vessel damage, bleeding and glass particles in the circulatory system.

“Cook Medical has notified its customers and distributors by recall notification letters,” Cook Medical announced on its website. “The letters requested that all customers and distributors quarantine and discontinue use of all recalled units and return the affected products to Cook as soon as possible for credit.”

The company added that it informed the proper regulatory agencies around the world of the issue.

Michelle Llamas, Senior Content Writer
Written By Michelle Llamas Senior Writer

Michelle Llamas has been writing articles and producing podcasts about drugs, medical devices and the FDA for nearly a decade. She focuses on various medical conditions, health policy, COVID-19, LGBTQ health, mental health and women’s health issues. Michelle collaborates with experts, including board-certified doctors, patients and advocates, to provide trusted health information to the public. Some of her qualifications include:

  • Member of American Medical Writers Association (AMWA) and former Engage Committee and Membership Committee member
  • Centers for Disease Control and Prevention (CDC) Health Literacy certificates
  • Original works published or cited in The Lancet, British Journal of Clinical Pharmacology and the Journal for Palliative Medicine

4 Cited Research Articles writers follow rigorous sourcing guidelines and cite only trustworthy sources of information, including peer-reviewed journals, court records, academic organizations, highly regarded nonprofit organizations, government reports and interviews with qualified experts. Review our editorial policy to learn more about our process for producing accurate, current and balanced content.

  1. FDA. (2016, August 31). FDA requires strong warnings for opioid analgesics, prescription opioid cough products, and benzodiazepine labeling related to serious risks and death from combined use.
  2. FDA. (2016, September 1). Potential Risk of Severe Bleeding and Hematomas Associated with VASCU-GUARD Peripheral Vascular Patch – Letter to Health Care Providers. Retrieved from
  3. Cook Medical. (2016, August 12). Cook Medical Issues Global Recall of Roadrunner® UniGlide® Hydrophilic Wire Guides due to raw materials issue. Retrieved from
  4. FDA. (2016. September 7). Cook Medical Recalls Roadrunner® UniGlide® Hydrophilic Wire Guide Because of Potential Coating Contamination. Retrieved from
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