Palmaz BLUE Transhepatic Biliary Stent on SLALOM .018 System PB1870BSXRecalls & 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 20705032036198), received between Jun 15, 2023 and Jun 15, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Deflation Problem” (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
- Deflation Problem1
- Inflation Problem1
- Migration1
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 15, 2023Deflation Problem; Inflation Problem; Migration; Deflation Problem; Inflation Problem; Migration
AS REPORTED, WHEN ATTEMPTING TO DEPLOY THE STENT OF A 7MM X 18MM135CM PALMAZ BULE ON SLALOM BILIARY STENT DELIVERY SYSTEM (SDS) IN THE CELIAC ARTERY, THE BALLOON WOULD NOT FULLY INFLATE AT 10 ATMOSPHERES (ATM). THE PHYSICIAN THEN INFLATED THE STENT BALLOON TO 20 ATM AND THE STENT WAS ABLE TO BE DEPLOYED; HOWEVER, THE BALLOON COULD NOT BE DEFLATED. A NEW INFLATION DEVICE WAS OPENED TO TRY AND DEFLATE THE BALLOON BUT WAS UNSUCCESSFUL. AN ATTEMPT TO PUNCTURE THE BALLOON WITH A NON-CORDIS .018 GUIDEWIRE WAS MADE BUT WAS UNSUCCESSFUL AS WELL. THE INFLATED BALLOON WAS THEN WITHDRAWN INTO THE PATIENT'S AORTA; HOWEVER, THERE WAS SUSPICION THAT THE STENT WAS PULLED BACK DURING THE WITHDRAWAL. MULTIPLE ATTEMPTS TO SNARE THE BALLOON WITH AN UNKNOWN SNARING DEVICE WERE MADE BUT WERE ALSO UNSUCCESSFUL. THE PATIENT WAS THEN TRANSFERRED TO ANOTHER HOSPITAL WHERE THE SLALOM SDS WAS ABLE TO BE PUNCTURED AND REMOVED. THE PATIENT WAS STABLE AND DISCHARGED POST PROCEDURE. THE DEVICE WAS STORED AND OPENED PER THE INSTRUCTIONS FOR USE (IFU) AND THERE WAS NO DAMAGE OBSERVED UPON OPENING THE DEVICE. THE BALLOON WAS PREPPED WITH A 50/50 CONTRAST AND SALINE MIXTURE. A 90CM NON-CORDIS CATHETER SHEATH INTRODU
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17133593 ↗
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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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