Palmaz BLUE Transhepatic Biliary Stent on SLALOM .018 System PB1870BSSRecalls & reported problems
Cordis US Corp. · 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 20705032036181), received between Oct 5, 2021 and Oct 5, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).
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
- Device Dislodged or Dislocated1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 5, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated
AS REPORTED, TWO 6MM X 18MM PALMAZ STENTS DID NOT COME OFF BALLOON BUT COULD NOT BE WITHDRAWN INTO GUIDE CATHETER. THE STENT CAME OFF BALLOON ONLY WHEN THEY TRIED TO WITHDRAW STENT INTO GUIDE AND SHEATH AND SUBSEQUENTLY CAME OFF INTO SUB CUTANEOUS SPACE. THE PHYSICIAN WAS TRYING TO TREAT THE LEFT RENAL ARTERY FROM THE RIGHT SIDE OF THE PATIENT. THE LESION HAS A 90% STENOSIS AND MEASURED TO BE 12-15MM IN LENGTH. THE VESSEL HAD MILD-MODERATE CALCIFICATION AND TORTUOSITY. THE PALMAZ STENT WOULD NOT CROSS THE HEAVILY CALCIFIED LESION. WHILE TRYING TO REMOVE THE STENT FROM THE PATIENTS BODY, THE STENT WAS STRIPPED OFF THE BALLOON IN THE GROIN WHILE ATTEMPTED TO BE PULLED THROUGH A NON-CORDIS IMA GUIDE CATHETER. ACCORDING TO THE PHYSICIAN, THE STENT WAS NOT IN THE ARTERY. THE STENT WAS LEFT IN THE PATIENTS BODY IN THE SUB CUTANEOUS SPACE. THE SECOND ATTEMPT TO TREAT LEFT RENAL ARTERY WAS MADE FROM THE LEFT SIDE OF THE PATIENT. THE STENT WOULD NOT CROSS THE LESION, SO THE PHYSICIAN ATTEMPTED PRE-DILATE THE LESION WITH A 6MM NON-CORDIS BALLOON. THE BALLOON WAS REMOVED AND THE STENT STILL WOULD NOT CROSS THE LESION. ONCE AGAIN, WHILE PULLING THE STENT THROUGH THE 6F NON-CORDIS IMA GUIDE CAT
Patient problems: Foreign Body In Patient
MAUDE report 12579088 ↗
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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.
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