S.M.A.R.T. C10080SBRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20705032024690), received between Jul 3, 2019 and Mar 9, 2020 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K042969); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathMar 9, 2020Adverse Event Without Identified Device or Use Problem

  MIDDLE-AGED FEMALE UNDERWENT A CARDIAC CATHERIZATION UTILIZING CUTTING BALLOON CATHETER TO RESTORE FLOW TO EXISTING STENT RE-STENOSIS. THE PROCEDURE WAS COMPLICATED BY AN ELLIS TYPE III PERFORATION REQUIRING EMERGENT PERICARDIOCENTESIS, PIGTAIL DRAIN PLACEMENT, PROLONGED INTRACORONARY BALLOON INFLATION TO CONTROL BLEEDING INTO THE PERICARDIUM, AND COVERED STENT PLACEMENT FOR FINAL STABILIZATION OF THE ARTERY. PATIENT ARRESTED DURING PROCEDURE, REQUIRING SEVERAL ROUNDS OF CPR, INTUBATION / MECHANICAL VENTILATION, HIGH DOSE INOTROPIC SUPPORT AND INTRA-AORTIC BALLOON PUMP (IABP) PLACEMENT TO ACHIEVE STABILIZATION. PATIENT WAS TRANSFERRED TO THE ICU WHERE SHE ENDURED ANOTHER CARDIAC ARREST AND UNFORTUNATELY EXPIRED.

  Patient problems: Cardiac Arrest; Death; Extubate; Perforation

  MAUDE report 9804981 ↗
• InjuryJul 3, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  AS REPORTED, THE PATIENT HAD A 10X80 SMART CONTROL BILIARY STENT PLACED TO GET BETTER FLOW IN THE LEFT EXTERNAL ILIAC BEFORE A SCHEDULED SURGERY, AND APPROXIMATELY FIVE DAYS LATER WHEN THE PATIENT CAME BACK FOR SCHEDULED SURGERY, THE DOCTOR FOUND A SIX-INCH PIECE OF PLASTIC WHILE DOING THE SURGERY. THEY REALIZED THE PLASTIC WAS FROM THE CATHETER THAT DEPLOYED THE SMART CONTROL STENT. THE PLASTIC PIECE WAS RETRIEVED BY SURGERY, AND THE PATIENT HAS RECOVERED. A TOTAL OF TWO CORDIS STENTS WERE PLACED. THE DEVICE WAS STORED, HANDLED, INSPECTED, AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE DEVICE PREPPED NORMALLY AND THERE WAS NO DIFFICULTY ENCOUNTERED FLUSHING THE STOPCOCK OR THE STENT DELIVERY SYSTEM (SDS). THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (CTO). A 6F UNKNOWN SHEATH WAS USED. THERE WAS NO DIFFICULTY OR RESISTANCE NOTED WHILE CROSSING THE LESION WITH THE STENT. NO EXCESSIVE TORQUING WAS REQUIRED. THERE WAS NO RESISTANCE MET WHILE ADVANCING THE DEVICE OVER THE GUIDEWIRE. THE DEVICE DID NOT KINK IN THE AREA OF SEPARATION. THE SHEATH WAS NOT KINKED OR HAD BEEN TWISTED/TORQUED PRIOR TO THE SEPARATION. THERE WAS NO RESISTANCE MET WHILE WITHDRAWING THE DE

  Patient problems: Foreign Body In Patient

  MAUDE report 8757219 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042969. One submission often covers many models, so check the product and lot details in each record.

• Z-1508-2012 · Apr 9, 2012 · Terminated
  Product is labeled in part: Inner Label "***SMART Control Transhepatic Biliary Stent***REF Cat. No.***Lot No.***Use By***Cordis S.M.A.R.T. CONTROL Nitinol Stent Transhepatic Bilia
• Z-1507-2012 · Apr 9, 2012 · Terminated
  Product is labeled in part: Inner Label "***S.M.A.R.T. Transhepatic Biliary Stent***REF Cat. No.***Lot No.***Use By***Cordis S.M.A.R.T. Nitinol Stent Transhepatic Biliary System**