FDA Medical Device Recalls in 2021

Each year thousands of reports are sent to the Food and Drug Administration that detail malfunctions, serious injuries and even deaths associated with medical devices. The FDA collects the data from all of the reports and make it available to manufacturers, physicians, patients, and researchers through its Manufacturer and User Facility Device Experience database (MAUDE). As per Mass Device the following is a list of medical devices that have been recalled in 2021:

• Lepu Medical’s COVID-19 Antigen and Antibody Test Kits: Recall Date: June 1, 2021
  • The FDA confirmed that Lepu Medical’s recall of its COVID-19 antigen and antibody test kits was a Class I. The company recalled the test kits because of a likely risk of false results.

• Boston Scientific Stent: Recall Date: May 21,2021
  • The FDA announced Boston Scientific’s recall of its VICI SDS and VICI RDS venous stent systems as Class I recall. The company recalled the stent systems following reports indicating that they may migrate or move from where they are initially implanted.

• Abbott Pacemakers: Recall Date: May 13, 2021
  • Pacemakers from Abbott were recalled due to possibilities of short circuit because they allowed moisture inside.

• Medtronic HeartWare Instructions Manual: Recall Date: May 12, 2021
  • Medtronic recalled its HeartWare instructions for use and patient manual due to risks from dropping the case, incorrect installation, and misinterpretation of an alarm signal.

• BD Alaris Infusion Pump: Recall Date: April 30,2021
  • A third Class I recall was issued for the Alaris pump due to the separation of one or more bezel repair posts that could have resulted in free flow of fluid to patients.

• Cordis Precise Pro Rx: Recall Date: April 23,2021
  • A Class I recall was announced for certain lots of Cordis’ Precise Pro Rx carotid system. The recall came after risks of separation of the atraumatic distal tip of the sheathed delivery system in patients.

• Medtronic Blood Pump: Recall Date: April 20,2021
  • Medtronic recalled their blood pump, Bio-Console 560, due to electrical failure.

• BD Alaris Infusion Pump: Recall Date: April 19, 2021
  • Only a few days after the FDA issued a Class I recall, they issued another recall for the same Alaris infusion pump. The most recent recall comes due to a risk of the keypad lifting up due to fluid entry.

• BD Alaris Infusion Pump: Recall Date: April 16, 2021
  • The FDA recalled the BD Alaris infusion pump which was considered a Class I recall.

• Medtronic HeartWare Ventricular Assist Device: Recall Date: April 15, 2021
  • The latest recall involves battery cables, data cables, adapter cables and controller 2.0 ports for HeartWare. Wear and tear of the connector plugs can damage the controller port metal pins, preventing connection of power cables and data cables and causing a full or partial stop of the pump.

• Smisson-Cartledge Biomedical Emergency Infusion Device Kit: Recall Date: April 12, 2021
  • The Class I recall covered three models of disposable sets made by Smisson-Cartledge Biomedical for its ThermaCor 1200 rapid infuser, which is used for fluid or bolus delivery.

• Medtronic ICDs and CRT-Ds: Recall Date: April 12, 2021
  • A Class I recall was designated to Medtronic for 239,171 ICDs and CRT-Ds with potential battery life problems. The devices’ problems involved a potential short circuit that could’ve caused an unexpected and rapid decrease in battery life.

• BD ChloraPrep 3 mL Applicator: Recall Date: March 25, 2021
  • BD expanded a voluntary recall of its ChloraPrep 3 mL applicator. The initial recall specified catalog numbers of the applicator device on June 23, 2020, due to possible fungal contamination under certain environmental conditions.

• Medtronic Oxygenator: Recall Date: March 25, 2021
  • A recall by the FDA was announced towards Medtronic oxygenator used on kids. The Affinity Pixie oxygenator is designed for treating newborns, infants and small pediatric patients requiring cardiopulmonary bypass. The recall notice states that Medtronic is recalling the Affinity Pixie with Balance biosurface due to potentially elevated levels of harmful bacteria called endotoxins.

• Lumiradx SARS-Cov-2 Antigen Test: Recall Date: March 23, 2021
  • LumiraDx issued an urgent device recall regarding a software update for its SARS-CoV-2 antigen test. The reason for the recall was due to the company receiving a customer complaint about a suspected false-positive result with the antigen test. An investigation found a manufacturing issue that resulted in a small number of sequential test strips in certain batches potentially producing false positives.

• Combat Medical Systems Transfusion: Recall Date: March 15, 2021
  • The Food and Drug Administration announced a Class I recall for transfusion sets made by Combat Medical Systems. Included in the recall was the Valkyrie LTOWB Collection and Administration set, Low Titer Type O Transfusion Set and Low Titer Type O Donor Collection Set, and the Fresh Whole Blood Transfusion Set and Fresh Whole Blood Donor Set.

• Heartware HVAD Pump Implant Kit- Recall Date: March 1, 2021
  • A recall was released from Medtronic for its HeartWare HVAD pump implant kit. The device may fail to start, restart, or have a delay in restarting after the pump was stopped. If the device has delays or fails to start or restart, this could cause serious patient harm including a heart attack, worsening heart failure, the need for additional procedures and hospitalizations, or death.

• Cordis Precise Pro RX Carotid Stent Systems: Recall Date: February 22, 2021
  • Cordis recalled and removed certain lots of their Precise Pro RX carotid stent systems. The Precise Pro RX carotid stent has the potential for the distal tip to become separated from the wire lumen on certain lots. The separation could result in an intra-procedural delay while a replacement device is prepared, unplanned percutaneous or surgical intervention or stroke.

• Boston Scientific Implantable Cardioverter Defibrillator (ICD): Recall Date: February 22, 2021
  • The Food and Drug Administration issued a second Class I recall on a Boston Scientific implantable cardioverter defibrillator (ICD). The company warned and notified physicians that 3,350 Emblem S-ICD model A209 and A219 devices may exhibit electrical overstress while delivering high-voltage therapy.

• Valiant Navion Thoracic Stent Graft Systems: Recall Date: February 17, 2021
  • Medtronic issued a voluntary recall of unused Valiant Navion thoracic stent graft systems. The global recall also included informing physicians to immediately stop the use of the device until further notice. The recall was in response to information obtained from the Valiant Evo global clinical trial which indicated that three patients in the trial experienced stent fractures.

• Enroute Transcarotid Stent System: Recall Date: January 25, 2021
  • Silkroad announced a voluntary recall for additional lots of its Enroute transcarotid stent system. Reports stated that the devices posed a danger due to tips detaching from the stent delivery system.