Maquet Medical Systems’ TigerPaw II surgical staple is the subject of a nationwide recalled. All lots are affected and were distributed from April 1, 2013, through March 23, 2015. There were 4,154 units distributed in the U.S. The affected two serial numbers are: C-TP-1507 and C-TP-1509.
The TigerPaw II is a surgical staple used to close tissue in the left atrial appendage (LAA) of the heart.
The recall was issued because an incomplete closure of the TigerPaw System II may result in tissue tears and/or bleeding. Also possible tearing on the left atrial wall (top left chamber) may occur during use of the device. The firm received 51 reports of adverse events and one death.
The FDA has classified this as a Class I recall, which is the most serious type of recall. Class I recalls involve situations in which there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
See the Recall
See also Medical Law Perspectives, February 2015 Report: Mending a Broken Heart: Malpractice Risks in Diagnosing and Treating Heart Disease
See also Medical Law Perspectives, February 2014 Report: Congenital Heart Conditions: How Infants, Adults, and Healthcare Providers Handle the Risks
See also Medical Law Perspectives, November 2013 Report: Diagnosis and Treatment of Heart Attacks: Liability Issues