Palmaz BLUE Transhepatic Biliary Stent on SLALOM .018 System PB1850BSXRecalls & 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 20705032036099), received between Jun 14, 2021 and Jun 14, 2021 — classified as 1 injury.
The most frequently reported specific device problem is “Crack” (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
- Crack1
- Device Dislodged or Dislocated1
- Inflation Problem1
- Therapy Delivered to Incorrect Body Area1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 14, 2021Crack; Inflation Problem; Therapy Delivered to Incorrect Body Area; Device Dislodged or Dislocated; Crack; Inflation Problem; Therapy Delivered to Incorrect Body Area; Device Dislodged or Dislocated
AS REPORTED, THE BALLOON OF 5MM X 18MM X 135CM PALMAZ BLUE TRANSHEPATIC BILIARY STENT ON SLALOM PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON EXPANDABLE STENT DELIVERY SYSTEM (SDS) WOULD NOT INFLATE WHEN ATTEMPTED TO DEPLOY. STENT THEN STRIPPED OFF BALLOON CATHETER, REQUIRING THEM TO GET A NEW UNKNOWN BALLOON THROUGH UNDEPLOYED STENT AND WERE REQUIRED TO DEPLOY BUT GEOGRAPHICALLY MISSED THE LESION IN THE SUPERIOR MESENTERIC ARTERY (SMA) AS A RESULT. THE DEVICE WAS STORED AS PER LABELING AND OPENED IN STERILE FIELD. THE DEVICE WAS USED IN PATIENT. THE INTENDED PROCEDURE WAS A SUPERIOR MESENTERIC ARTERY (SMA) STENT PROCEDURE. THE ACCESS SITE WAS THE LEFT FEMORAL. THE LESION HAD LITTLE CALCIFICATION. THERE WAS NO VESSEL TORTUOSITY. THE PERCENTAGE OF STENOSIS WAS >80%. THE DEVICE WAS NOT USED FOR A CHRONIC TOTAL OCCLUSION (TOTAL OCCLUSION >3 MONTHS). A 5F 90CM NON-CORDIS SHEATH WAS USED. THE LESION WAS NOT PRE-DILATED PRIOR TO STENT IMPLANTATION. THERE WERE NO VISIBLE SIGNS OF DEVICE/PACKAGE DAMAGE PRIOR TO USE. THERE WERE NO ANOMALIES NOTED WHEN THE DEVICE WAS TAKEN OUT OF THE PACKAGE. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11990934 ↗
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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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