Baylis Med Tech Passport Steerable Sheath PSS0706509Recalls & reported problems
Oscor Inc. · Passport Steerable Sheath 7F · Class 2
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 00885672012564), received between Jul 26, 2024 and Jul 26, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).
1 other recall cover devices cleared under the same FDA submission (K140406); 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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJul 26, 2024Fluid/Blood Leak; Fluid/Blood Leak
DURING A MESENTERIC INTERVENTION PROCEDURE, A SURGEON PLACED A PASSPORT STEERABLE SHEATH OVER A STIFF WIRE FROM LEFT AXILLARY PERCUTANEOUS ACCESS INTO THE DESCENDING THORACIC AORTA. SHORTLY AFTER PLACEMENT, THE VALVE OF THE SHEATH BEGAN LEAKING HEAVILY. DUE TO THE CHALLENGING LOCATION, GETTING AN APPROPRIATELY SIZED REPLACEMENT SHEATH IN PLACE TOOK SEVERAL MINUTES, RESULTING IN APPROXIMATELY 250-300CC OF BLOOD LOSS. THE SURGEON ATTEMPTED TO STOP THE BLEEDING BY REPLACING THE DILATOR, BUT IT DID NOT PASS EASILY, AND THE BLEEDING CONTINUED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLAYING THE SHEATH WITH A SIMILAR SIZED SHEATH. PLEASE NOTE THE IMPORTER'S REPORT NUMBER IS 9710452-2024-00005.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 19844484 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K140406. One submission often covers many models, so check the product and lot details in each record.
- Z-0646-2022 · Dec 22, 2021 · CompletedDestino Twist 14F (also branded as Guidestar 14F)
Other Introducer, catheter devices
- VIZIGO D138502Biosense Webster Inc · INTRODUCER, CATHETER2 recalls4 deaths2,839 reports
- VIZIGO D138501Biosense Webster Inc · INTRODUCER, CATHETER2 recalls2 deaths2,005 reports
- Swartz™ 407451St. Jude Medical, Inc. · INTRODUCER, CATHETER5 deaths728 reports
- Edwards eSheath+ Introducer set 914ESPEdwards Lifesciences LLC · Introducer, Catheter22 deaths532 reports
- Fast-Cath™ 406849St. Jude Medical, Inc. · INTRODUCER, CATHETER420 reports
- VIZIGO D138503Biosense Webster Inc · INTRODUCER, CATHETER362 reports
- Agilis™ G408318St. Jude Medical, Inc. · INTRODUCER, CATHETER333 reports
- Agilis™ NxT Steerable Introducer Dual-Reach™ SI-1371-MSt. Jude Medical, Inc. · Introducer, catheter1 death301 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.
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