Recalls for Heart

Beacon Tip Angiographic Catheters by Cook Medical: Class 1 Recall - Catheter Tip May Slip or Separate
08/07/2015 Medical Recall

If this occurs, the tip could enter the patient’s bloodstream. This could cause serious injury to the patient and require additional medical intervention to retrieve the tip, or cause death.

  • Company:
    Cook Medical
Proglycem (diazoxide): Drug Safety Communication - Reports of Pulmonary Hypertension in Infants and Newborns
07/16/2015 Medical Recall

Monitor patients, especially those with risk factors for pulmonary hypertension, for signs of respiratory distress, including tachypnea, flaring nostrils, grunting, and chest wall retractions.

  • Company:
    Proglycem
Lariat Suture Delivery Device for Left Atrial Appendage (LAA) Closure by SentreHEART: FDA Safety Communication - Reports of Patient Deaths and Other Serious Adverse Events
07/13/2015 Medical Recall

Safety and effectiveness of the Lariat Suture Delivery Device to close the LAA and prevent stroke in patients with atrial fibrillation has not been established.

  • Category
    Heart
Asset Bold: Public Notification - Undeclared Drug Ingredient
05/16/2014 Medical Recall

Risk of increased blood pressure and/or pulse rate.

  • Category
    Heart
Asset Bee Pollen: Public Notification - Undeclared Drug Ingredient
05/12/2014 Medical Recall

Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients.

  • Category
    Heart
Slim Trim U: Public Notification - Undeclared Drug Ingredient
05/06/2014 Medical Recall

Risk of increased blood pressure and/or pulse rate.

  • Category
    Heart
Natural Body Solution: Public Notification - Undeclared Drug Ingredient
05/06/2014 Medical Recall

Risk of increased blood pressure and/or pulse rate.

  • Category
    Heart
Infinity: Public Notification - Undeclared Drug Ingredient
04/11/2014 Medical Recall

Use may increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.

  • Company:
    Infinity
Lite Fit USA: Public Notification - Undeclared Drug Ingredient
04/11/2014 Medical Recall

Use may increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.

  • Company:
    Lite Fit USA
Vitaccino Coffee: Public Notification - Undeclared Drug Ingredient
03/19/2014 Medical Recall

Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients, and may also present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.

  • Company:
    Vitaccino Coffee
Lexiscan (regadenoson) and Adenoscan (adenosine): Drug Safety Communication - Rare but Serious Risk of Heart Attack and Death
11/20/2013 Medical Recall

Cases of myocardial infarction and death have occurred following the administration of Lexiscan (regadenoson) injection or Adenoscan (adenosine) infusion.

  • Company:
    Lexiscan
St. Jude Amplatzer Atrial Septal Occluder (ASO): Safety Communication - Reports of Tissue Erosion
10/17/2013 Medical Recall

Tissue surrounding the Amplatzer ASO can break down (erode) and result in life-threatening emergencies that require immediate surgery.

  • Company:
    Amplatzer ASO
Perfect Body Solutions and Burn 7: Public Notification - Undeclared Ingredients
10/10/2013 Medical Recall

May increase blood pressure and/or pulse rate and can present a significant risk for patients with a history certain cardiovascular conditions or stroke.

  • Company:
    Perfect Body Solutions