Claim: Medtronic recalls heparin-coated bypass equipment.
Verdict: SUPPORTS

Retrieved passages:
title: Oxygenator
text: Carmeda Bioactive Surface and Duraflo II coatings. The researchers concluded that: Statistics and conclusions from more studies are available here. Clearly, heparin-coated blood oxygenators exhibit some advantages over non-coated oxygenators. Some hospitals use heparin-coated oxygenators for the large majority of their cases requiring cardiopulmonary bypass. It is unclear whether most surgeons actually reduce the amount of systemic heparin used when their patients are being perfused with heparin-coated oxygenators. Ultimately, each surgeon makes this decision based upon the needs of individual patient. Although they offer advantages, these oxygenators are not widely regarded by surgeons as revolutionary breakthroughs in cardiopulmonary bypass. This

title: Oxygenator
text: to decrease morbidity associated with CPB to a limited degree. Heparin-coated oxygenators are thought to: Heparin coating is reported to result in similar characteristics to the native endothelium. It has been shown to inhibit intrinsic coagulation, inhibit host responses to extracorporeal circulation, and lessen postperfusion, or “pumphead,” syndrome. Several studies have examined the clinical efficacy of these oxygenators. Mirow et al. 2001 examined the effects of heparin-coated cardiopulmonary bypass systems combined with full and low dose systemic heparinization in coronary artery bypass patients. The researchers concluded that Ovrum et al. 2001 compared the clinical outcomes of 1336 patients with the

title: 2008 Chinese heparin adulteration
text: 2008 Chinese heparin adulteration In March 2008, major recalls of heparin, a substance widely used as an injectable anticoagulant, were announced by the U.S. Food and Drug Administration (FDA) due to contamination of the raw heparin stock imported from China. The raw material for the recalled heparin batches was processed in China from pig's intestines by the American pharmaceutical firm Scientific Protein Laboratories. The U.S. Food and Drug Administration was quoted as stating that at least 81 deaths were believed to be linked to a raw heparin ingredient imported from the People's Republic of China, and that they had also

title: Baxter International
text: were never subjected to inspection by US FDA officials, as required by FDA regulations. In addition, Changzhou SPL's products were also never certified as safe for use in pharmaceutical products by Chinese FDA officials, due to Changzhou SPL's registration as a chemical company rather than a pharmaceutical manufacturer. Though Baxter was first to recall heparin because of increased adverse reactions, after the contaminant was identified and testing protocols were shared with other manufacturers globally, over a dozen other companies in nearly a dozen countries issued recalls, which linked back to certain supply points in China. In early 2009, samples of

title: Medtronic
text: Medtronic Carelink Model 2090 Programmer for Medtronic and Vitatron Devices; they use separate interfaces. In 2007, Medtronic recalled its Sprint Fidelis product, the flexible wires, or leads, which connect a defibrillator to the interior of the heart. The leads were found to be failing at an unacceptable rate, resulting in unnecessary shocks or no shocks when needed; either can be lethal. The scope of the problem continues to be a matter of research. Studies since the recall, disputed by Medtronic, suggest that the failure rate of already-implanted Sprint Fidelis leads is increasing exponentially. Medtronic's liability is limited by various court

title: 2008 Chinese heparin adulteration
text: are fully responsible for qualifying their suppliers through on-site audits, testing, and regular communications. This ongoing responsibility is essential to ensure supply chain security, drug quality and drug safety, These basic commitments to the pharmaceutical consumer can only be ensured by adherence to Good Manufacturing Practice and Good Distribution Practice. 2008 Chinese heparin adulteration In March 2008, major recalls of heparin, a substance widely used as an injectable anticoagulant, were announced by the U.S. Food and Drug Administration (FDA) due to contamination of the raw heparin stock imported from China. The raw material for the recalled heparin batches was processed

title: Becton Dickinson
text: 21 April 2008, the prosecutor's office in Lublin discontinued the inquiry, because the disposable syringes were not dangerous. In February 2010 BD announced a voluntary product recall of certain lots of BD Q-Syte Luer Access Devices and BD Nexiva Closed IV Catheter Systems. BD stated that the use of the affected devices may cause an air embolism or leakage of blood and/or therapy, which may result in serious injury or death. The approximately 2.8 million BD Q-Syte and 2.9 million BD Nexiva units containing 5 million BD Q-Syte devices that were recalled were distributed in the United States, Asia, Canada,

title: Heparin mimicking polymers
text: °C), it transitions to its rubbery state, allowing the nitinol to resume its corkscrew shape. Retrieval of the blood clot occurs through a pull back motion. The nitinol is engulfed in a tight space even though it is expanding and as a result retreats thus extracting the tissue. Heparin mimicking polymers Heparin Mimicking Polymers are synthetic compounds that possess similar characteristics to heparin, that is it can be used clinically as an anticoagulant. These compounds like heparin possess a negative charge density that allows it to interact and inhibit the coagulation process. Glucose or mannose-contain n-alkyl urea peptoid oligomer, glucose

title: Heparin mimicking polymers
text: polymers. Events such as the 2008 heparin contamination event, and mad cow disease further enhance the new demand for more robust anticoagulants. Additionally prolonged use of heparin results in heparin induced thrombocytopenia. Three aspects of synthetic mimicking polymers are currently focused on: mimicking anionic sulfate domains of heparin, polymerization of sulfated saccharides and sulfation of natural occurring GAGs. Heparin mimicking polymers can be synthesized through a variety of mechanisms. To begin, monomers can be either be synthesized or purchased from avenues such as Sigma Aldrich. The monomers are the basic subunits of the polymer and can be designed to incorporate

title: Baxter International
text: was brought into question when they were linked to 19 deaths in the United States. Upon inspection, one of the raw ingredients used by Baxter was found to be contaminated – between 5 and 20 percent – with a substance that was similar, but not identical, to the ingredient itself. The company initiated a voluntary recall, temporarily suspended the manufacture of heparin, and launched an investigation. The investigation into the contamination has focused on raw heparin produced by Changzhou Scientific Protein Laboratories, a China-based branch of Scientific Protein Laboratories, based in Waunakee, Wisconsin. Due to procedural errors, Changzhou SPL's facilities

title: Heparin mimicking polymers
text: Heparin mimicking polymers Heparin Mimicking Polymers are synthetic compounds that possess similar characteristics to heparin, that is it can be used clinically as an anticoagulant. These compounds like heparin possess a negative charge density that allows it to interact and inhibit the coagulation process. Glucose or mannose-contain n-alkyl urea peptoid oligomer, glucose modified diamine with pedant monosaccharides are examples of heparin mimicking polymers. Heparin mimicking polymers can also be used to create biomaterials for surgical application such as pacemakers, stents, etc. Heparin is widely used as a clinical anticoagulant however, it possesses drawbacks creating a need for synthetic heparin mimicking

title: Heparin
text: biological activity that influences the anticoagulation effect of heparin. In December 2007, the US Food and Drug Administration (FDA) recalled a shipment of heparin because of bacterial growth ("Serratia marcescens") in several unopened syringes of this product. "S. marcescens" can lead to life-threatening injuries and/or death. In March 2008, major recalls of heparin were announced by the FDA due to contamination of the raw heparin stock imported from China. According to the FDA, the adulterated heparin killed nearly 80 people in the United States. The adulterant was identified as an "over-sulphated" derivative of chondroitin sulfate, a popular shellfish-derived supplement often

title: Counterfeit medications
text: from which they were exported to U.S. wholesale distributors. The Wall Street Journal reported that the U.S. wholesale distributor was hired by Canada Drugs, which also owns CanadaDrugs.com, a retail pharmacy website that sells prescription medication internationally, with a focus on the American market. In 2007-08, 149 Americans died from a contaminated blood thinner called Heparin that was legally imported into the United States. Investigated by the FDA Office of Criminal Investigations, the Albers Medical investigation is the most prolific example to date. On August 21, 2005, the U.S. Attorney’s Office for the Western District of Missouri issued a press

title: Heparin mimicking polymers
text: Contact angle measurements can help determine the hydrophobicity or hydrophilicity of the polymer, this extremely useful for creating water-soluble biomaterials. Heparin-mimicking polymers can be used for a variety of applications in the body. These include, the coating for pacemakers, surgical catheter and stents. Shape memory heparin mimicking polymers can be used to create devices that extract hemorrhaging tissue. Microactuator (right) is a prototype endovascular electromechanical clot-extraction device. This device consists of electromechanical microactuator mounted on the distal tip of either a Prowler-14 microcatheter The microactuator is fabricated using a shape memory polymer (SMP) shell over a shape memory nickel-titanium alloy

title: Valsartan
text: Accord Healthcare. In Canada, the recall involves five companies and a class action suit has been initiated by a private law firm. Authorities believe the degree of contamination is negligible, and advise those taking the drug to consult a doctor and not to cease taking the medication abruptly. On July 12, 2018, The National Agency of Drug and Food Control (NA-DFC or Badan POM Indonesia) announced voluntary recalls for two products containing valsartan produced by Actavis Indonesia and Dipa Pharmalab Intersains. On July 13, 2018, the FDA announced voluntary recalls of certain supplies of valsartan and valsartan/hydrochlorothiazide (HCTZ) in the

title: Oxygenator
text: surgery and disrupt homeostasis. The inflammatory responses can produce microembolic particles. A greater source of such microemboli are caused by the suction of surgical debris and lipids into the CPB circuit. Microparticles obstruct arterioles that supply small nests of cells throughout the body and, together with cytotoxins, damage organs and tissues and temporarily disturb organ function. All aspects of cardiopulmonary bypass, including manipulation of the aorta by the surgeon, may be associated with neurological symptoms following perfusion. Physicians refer to such temporary neurological deficits as “pumphead syndrome.” Heparin-coated blood oxygenators are one option available to a surgeon and a perfusionist

title: 2008 Chinese heparin adulteration
text: fraction of true heparin starting material, and mimics the in-vitro properties of heparin, the counterfeit was almost certainly intentional as opposed to an accidental lapse in manufacturing. The raw heparin batches were found to have been cut from 2–60% with the counterfeit substance, and motivation for the adulteration was attributed to a combination of cost effectiveness and a shortage of suitable pigs in China. When the FDA conducted an inspection of Baxter's Chinese Heparin supplier, it found serious deficiencies at the facility which the FDA detailed in a warning letter. This example once again demonstrated the consequences of a company

title: 2010 DePuy Hip Recall
text: 2010 DePuy Hip Recall The 2010 DePuy Hip Replacement Recall was instituted when DePuy Orthopaedics, Inc., a division of Johnson and Johnson, recalled its ASR XL Acetabular metal-on-metal hip replacement system on August 24, 2010. The recall came after data from a study indicated that the five year failure rate of this product is approximately 13%, or 1 in 8 patients. Even if the defective device is replaced, it can leave behind dangerous, possibly deadly fragments that may not be discovered for years. DePuy identified reasons for the failure of the hip replacement system as component loosening, component malalignment, infection,

title: Oxygenator
text: uncoated CPB circuits require a high dose of systemic heparin. Although the effects of heparin are reversible by administering protamine, there are a number of side effects associated with this. Side effects can include allergic reaction to heparin resulting in thrombocytopenia, various reactions to the administration of protamine and post-operative hemorrhage due to inadequate reversal of the anticoagulation. Systemic heparin does not completely prevent clotting or the activation of complement, neutrophils, and monocytes, which are the principal mediators of the inflammatory response. This response produces a wide range of cytotoxins, and cell-signaling proteins that circulate throughout the patient's body during

title: 2008 Chinese heparin adulteration
text: not following basic Good Manufacturing Practices (GMPs). As detailed in the Warning Letter, the company failed to monitor changes in the impurity profile of incoming heparin active raw material, adequately investigate out-of-specification results, document actual processing steps in batch records, validate all critical steps in the process, qualify all suppliers, and use valid methods to test products. The FDA has stated that it does not have the funds nor bear the responsibility to inspect on a regular basis overseas upstream processors of finished active pharmaceutical ingredients such as heparin. However, according to the internationally harmonized guideline, ICH Q7, API manufacturers