S.M.A.R.T. C09080MBRecalls & reported problems
Cordis US Corp. · PKG ASSY 9X080 SMART BIL 120CM · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20705032024478), received between Feb 24, 2020 and Feb 24, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Difficult or Delayed Positioning” (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
Device problems
- Difficult or Delayed Positioning1
- Difficult to Remove1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryFeb 24, 2020Difficult or Delayed Positioning; Difficult to Remove; Difficult or Delayed Positioning; Difficult to Remove
AS REPORTED, THE DEPLOYMENT SYSTEM OF A 120CM X 9MM X 80 SMART CONTROL BILIARY STENT DID NOT ENGAGE AT ALL. THEREFORE, THE DEVICE WAS PULLED, HOWEVER, THE STENT GOT DISLODGED AND STUCK AT THE END OF THE SHEATH AND A CUTDOWN WAS PERFORMED TO RETRIEVE THE STENT. THE DEVICE WILL BE RETURNED FOR EVALUATION.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9747253 ↗
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 · TerminatedProduct 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 · TerminatedProduct 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**
Other Stents, Drains And Dilators For The Biliary Ducts devices
- Hurricane™ RX M00545900Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC2 recalls1 death705 reports
- MUSTANG™ H74939171060470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC384 reports
- CRE™ PRO M00558710Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC1 recall284 reports
- Hurricane™ RX M00545920Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC2 recalls211 reports
- MUSTANG™ H74939171070470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC265 reports
- MUSTANG™ H74939171050470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC212 reports
- Hurricane™ RX M00545940Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC2 recalls109 reports
- MUSTANG™ H74939171100470Boston Scientific Corporation · CATHETER, BILIARY, DIAGNOSTIC203 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page