Baylis Med Tech Passport Steerable Sheath PSS0705509TDRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885672012595), received between May 9, 2024 and Jan 23, 2026 — classified as 1 injury, 1 malfunction.

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  INFORMATION RECEIVED FROM SALES ON 31-DEC-2025: CUSTOMER REPORTED HEMATOMA FORMATIONS IN (3) SEPARATE PATIENTS WHEN USING THE PASSPORT TD CURVE, THE COMPLAINT HAS BEEN ELEVATED TO THE ADMINISTRATION OF THE QUALITY AND SAFETY STAFF AT (B)(6) HOSPITAL. "THIS IS OUR 3RD FAILURE OF THIS PRODUCT WHICH RESULTED IN MASSIVE HEMATOMAS REQUIRING TWO PATIENTS TO GO TO OR FOR OPEN REPAIR OF ARTERY. ALL 3 FAILURES WERE FOR A 9MM SHEATH W/2 VERY NOTABLE EXTRAVAGATION EVENTS. DIFFERENT PHYSICIAN USERS. WE NEED AN EVALUATION OF THE DEVICE BY VENDORS AND FOR THEM TO MEET WITH OUR PHYSICIANS TO SEE IF THIS IS AN INTRODUCER ERROR OR SHEATH ERROR. PRODUCTS WERE NOT RETAINED FOLLOWING THE PROCEDURE DUE TO URGENT NEED TO TRANSITION PATIENT TO OR SUITES." "THE SAME LOT NUMBER FOR ALL 3 PATIENTS". ASSOCIATED COMPLAINTS: (B)(4).

  Patient problems: Hematoma

  MAUDE report 24161251 ↗
• MalfunctionMay 9, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED FLUID, RED IN COLOR, WAS LEAKING FROM HEMOSTATIC VALVE, LOCATED ON THE PROXIMAL PORTION OF THE HANDLE. IMMEDIATELY THEREAFTER INSERTION, IN-VIVO LEAKAGE RANGING FROM LOW-FLOW TO MODERATE FLOW OF FLUID RED IN COLOR FROM THE DEVICE HEMOSTATIC VALVE OCCURRED OTW, OTW&C DURING STATIC AND DYNAMIC CONDITIONS IN LINE WITH THE INSTRUCTIONS FOR USE (IFU). IT WAS REPORTED ALL PREPROCEDURAL AND INTRAPROCEDURAL STEPS WERE TAKEN PER THE IFU. A SECOND DEVICE OF THE SAME MODEL AND LOT, WAS USED BUT THE OCCURRENCE REPEATED ITSELF. DOCTOR USED AN ANSEL FIXED CURVED CATHETER AND PROCEDURE WAS COMPLETED. THER WAS NO DELAY IN THE PROCEDURE AND NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19277988 ↗

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 · Completed
  Destino Twist 14F (also branded as Guidestar 14F)