title: The nature and pattern of coronary stent recalls.
abstract: BACKGROUND
  Each year, over 1 million percutaneous coronary interventions (PCIs) are performed in the United States. Coronary stents have been shown to reduce restenosis or abrupt vessel closure and therefore have improved the success of PCI. Rarely, manufacturers recall stents due to unanticipated problems. We sought to study the extent and pattern of stent recall.
  
  
  OBJECTIVE
  To determine the number and rate of stent recall and safety alerts, to identify trends in the rates, and to identify the nature of stent recalls.
  
  
  METHODS
  The Food and Drug Administration (FDA; http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm) and Healthcare Recall Management websites (RASMAS; https://alerts.rasmas.noblis.org/rasmas/c/selectViewAlertList.do) were searched. The search terms for recall were, "coronary stent" or "stent."
  
  
  METHODS
  Dates were searched between November 2002 and June 2013.
  
  
  RESULTS
  There were 17 coronary stent recalls involving almost 500,000 units; 12 recalls (71%) were before 2006 and 5 recalls (29%) were after. Thirteen recalls (76%) consisted of class II recalls (moderate hazard); the remaining 4 were equally split between class I (severe hazard) and class III (mild hazard; 12% each). The common reasons for recall were concerns with sterility (29%) followed by wrong labeling/packaging (23%) and impaired delivery of stent (18%). In terms of units involved with recalls, 98% (472,189/481,131) were related to wrong labeling/ packaging or misbranding, while 0.1% (542/481,131) were related to potential for broken struts or crack in inflation port hub or sterility. However, approximately 2% of units were related to the potentially lethal problem of impaired balloon inflation. Recalls involved multiple manufacturers with various stent types.
  
  
  CONCLUSIONS
  The overall incidence of coronary stent recall is low and has declined over the years. The majority of stent recalls are of moderate hazard. However, due to the possibility of serious injury, clinicians should be aware of recalls.
authors.affiliation: Cardiac Catheterization and Interventional Cardiology, SUNY Downstate Medical Center, 450 Clarkson Avenue, Box 1257, Brooklyn, NY 11203- 2098 USA. jmarmur@gmail.com.
authors.forename: Sanjay
authors.initials: S
authors.lastname: Kumar
authors.forename: Antony L
authors.initials: AL
authors.lastname: Innasimuthu
authors.forename: Jonathan D
authors.initials: JD
authors.lastname: Marmur
mesh_terms: D004868:Equipment Failure / Q000706:statistics & numerical data; D006801:Humans; D015994:Incidence; D057052:Medical Device Recalls; D062645:Percutaneous Coronary Intervention / Q000295:instrumentation*; D019064:Product Packaging / Q000706:statistics & numerical data; D012189:Retrospective Studies; D015607:Stents / Q000009:adverse effects* / Q000706:statistics & numerical data*; D013242:Sterilization / Q000706:statistics & numerical data; D014481:United States; D014486:United States Food and Drug Administration