Penumbra’s JET 7 Xtra Flex Catheter Recall News – Penumbra issued a recall for all models of its JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7 Xtra Flex) due to unexpected deaths and serious injuries while being used for removing clots in stroke patients. Penumbra’s JET 7 Xtra Flex Catheter Recall Information On December 15, 2020, Penumbra issued an urgent recall for consumers and providers for all configurations of the JET 7 Xtra Flex due to “unexpected death or serious injury” while the affected product was being used for removing clots in stroke patients. Use of the JET 7 Xtra Flex should cease immediately and facilities should take the affected devices out of their inventory. The affected JET 7 Xtra Flex devices include: All lots of Penumbra JET 7 Reperfusion Catheter and Penumbra Hi-Flow Aspiration Tubing with Catalog Read More
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December 12, 2020: MPM Medical Issues Nationwide Recall of Regenecare HA Hydrogel Due to Burkholderia cepacia Contamination
Regenecare HA Hydrogel Recall News – MPM Medical has issued a recall for one lot of Regenecare HA Hydrogel. Following customer complaints of visible contamination, the Regenecare product tested positive for Burkholderia cepacia (B. cepacia). Regenecare HA Hydrogel Recall Information On December 2, 2020, MPM Medical, of Mesquite, TX, issued a recall for one lot of its Regenecare HA Hydrogel product due to a B. cepacia contamination. The affected product was packaged in 3 oz. plastic tubes and distributed in boxes of 12. The recalled Regenecare HA Hydrogel can be identified by the following: NDC #66977-107-03; Lot #41262; Date: 2021-01 This product was distributed nationwide to wholesalers and healthcare facilities. Patients and healthcare facilities with this affected lot of Regenecare HA Hydrogel should stop use immediately. Consumers should contact their healthcare provider or physician if they have experienced any problems. Read More
July 8, 2020: Postmarket Surveillance Results for Essure Birth Control Issued by FDA
Essure Postmarket Surveillance Results News – The U.S. Food and Drug Administration (FDA) has posted interim results for the postmarket surveillance study of Essure, a permanent implanted birth control device for women. Sales of Essure in the U.S. stopped in December 2018. Implantation of the Essure birth control device is no longer available as of December 2019. Essure Postmarket Surveillance Results Information On July 8, 2020, the FDA issued its postmarket surveillance results for Essure. The FDA has continued to recommend that women who have been using Essure successfully can and should continue to do so. But, women who believe the device may be related to certain symptoms they have, such as persistent pain, should speak with their doctor about appropriate steps. Patients should discuss the risks and benefits of any procedure with their doctor before deciding on the best Read More
June 19, 2020: FDA Cautions Certain COVID-19 Serology/Antibody Tests Should Not Be Used
COVID-19 Antibody Tests News – The U.S. Food and Drug Administration (FDA) has recommended that clinical laboratories and health care providers stop using COVID-19 antibody tests listed on the FDA’s “removed” test list. On May 15, 2020, the FDA also issued a public alert regarding the accuracy of the Abbott ID NOW point-of-care test for diagnosing COVID-19. COVID-19 Antibody Tests Information On June 19, 2020, the FDA issued a letter to clinical labs and health care providers advising that certain COVID-19 antibody tests should not be used. The FDA’s “removed” test list should be used by providers as a guideline for what tests to avoid. This list includes tests where significant clinical performance problems were identified that cannot be, or have not been, addressed by the commercial manufacturer in a timely manner and tests for which an Emergency Use Authorization Read More
May 15, 2020: FDA Issues Public Alert Regarding Accuracy Concerns With Abbott ID NOW Point-of-Care Test for Diagnosing COVID-19
On May 15, 2020, the U.S. Food and Drug Administration (FDA) issued an alert for the public advising that early data for the Abbott ID NOW point-of-care test, used to diagnose COVID-19 (coronavirus), suggest possible inaccurate results which elicit false negatives. Abbott ID NOW COVID-19 Test Alert Information The FDA is issuing this information as a gesture of transparency regarding testing. They are working closely with Abbott to review the available data and information. Abbott is collaborating with the FDA to draft a customer notification letter alerting consumers that any negative test results not consistent with a patient’s clinical signs and symptoms should be followed up and confirmed with another test. Per Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health: We are still evaluating Read More
May 7, 2020: FDA Advises Certain Filtering Facepiece Respirators from China May Not Provide Appropriate Respiratory Protection
Respirators from China News – The U.S. Food and Drug Administration (FDA) has issued a letter to the following regarding concerns with certain filtering facepiece respirators (respirators) from China: Chinese companies producing the at issue respirators, U.S. Health Care Personnel, Hospital Purchasing Departments/Distributors, and other applicable stakeholders/consumers. Respirators from China Information On May 7, 2020, the FDA issued a letter regarding concerns over certain respirators from China. The outlined respirators may not provide consistent and adequate respiratory protection to health care personnel exposed to COVID-19 (coronavirus) based on additional filtration performance testing conducted by the National Institute for Occupational Safety and Health (NIOSH) and National Personal Protective Technology Laboratory (NPPTL) of the Centers for Disease Control and Prevention (CDC). Pursuant to the testing, the FDA has revised and reissued its April 3, 2020 Emergency Use Order (EUA). Per the FDA, Read More
April 30, 2020: Vascular Solutions, Inc. Issues Recall for Langston Dual Lumen Catheter Product Due to Risk of Separation During Use
Langston Dual Lumen Catheter Recall News – Vascular Solutions, Inc. (Vascular Solutions) has issued a recall for its Langston Dual Lumen Catheter product due to the potential for separation during use. Langston Dual Lumen Catheter Recall Information On April 30, 2020, Vascular Solutions ordered a recall of its Langston Dual Lumen Catheter product due to the risk of the inner catheter separating during use. The Langston Dual Lumen Catheter is utilized by clinicians to see internal body structures by way of rapid delivery of dye (contrast material) into a patient’s blood vessels during medical imaging tests (angiographic studies). The affected device can also measure pressure within the blood vessel. Per the announcement, If the inner catheter separates, it could cause serious health conditions including additional surgical procedures to remove the separated section, damage to the blood vessel or death. If Read More
April 3, 2020: FDA Issues Update on COVID-19 (Coronavirus) Response
FDA COVID-19 Update News – On April 3, 2020, the U.S. Food and Drug Administration (FDA) issued an announcement with their continuing COVID-19 response. FDA COVID-19 Update Information The FDA has announced the following updates: They are working in collaboration with government, industry, and academic partners to develop and implement a protocol to provide convalescent plasma to patients in need throughout the U.S. Convalescent plasma, or plasma from people who have had the virus, has the potential to lessen the severity or shorten the length of illness from COVID-19. An FAQ as to whether respirators approved under standards used in other countries, such as KN95s, can be used in the US during the COVID-19 pandemic has been posted. A new Emergency Use Authorization (EUA) for non-NIOSH-approved respirators made in China has been issued allowing use of respirators approved in other countries, under Read More
February 12, 2020: Medtronic Initiates Recall for MiniMed Insulin Pumps due to Incorrect Insulin Dosing
Medtronic MiniMed Insulin Pump Recall News – Medtronic has issued a recall for its MiniMed Insulin Pump product due to incorrect insulin dosing. The U.S. Food and Drug Administration’s (FDA) has classified this as a Class I Recall. A Class I Recall is the most serious type of recall and use of these MiniMed Insulin Pumps may cause serious injury or death. Medtronic MiniMed Insulin Pump Recall Information On November 19, 2019, with updates to the FDA as of February 12, 2020, Medtronic initiated a recall for its MiniMed Insulin Pump products due to incorrect insulin dosages. Individuals with Type 1 diabetes may use the MiniMed insulin pump to deliver insulin for the management of their diabetes. The following information is subject to this specific MiniMed Insulin Pump recall: MiniMed 600 Series Insulin Pumps Model 630G (MMT-1715) – all lots Read More
July 24, 2019: Allergan Aesthetics Issues BIOCELL® Breast Implant Recall
On July 24, 2019, Allergan Aesthetics, an AbbVie company issued a global breast implant recall of all unused BIOCELL® implants after FDA warned of increased risk for breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). Allergan Aesthetics BIOCELL® Implant Recall Information The products affected by the breast implant recall that have links to BIA-ACL are BIOCELL® textured breast implants and tissue expanders. Though the risk of developing BIA-ALCL is low, the condition can be deadly. The affected products only include the textured breast implants, not the smooth BIOCELL® implants. The United States Food and Drug Administration (FDA) as well as Allergan Aesthetics recommends close monitoring of health symptoms if you or a loved one has a BIOCELL® breast implants or a history of BIOCELL® breast implants. BIA-ALCL is a serious condition and can lead to death, especially if not diagnosed early Read More
