Baylis Med Tech Passport Steerable Sheath PSS0705509Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885672012557), received between Apr 21, 2026 and Apr 21, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2026Deformation Due to Compressive Stress; Mechanical Jam

  THERE IS A 60-MINUTE PROCEDURE DELAY WITH THIS EVENT. DEFLECTION CODE ADDED AFTER THE MEETING WITH CUSTOMER ON 07APR2026. CUSTOMER ORGANIZATION: (B)(6). EVENT ORIGIN COUNTRY: CANADA. IS PRODUCT AVAILABLE TO BE RETURNED FOR INVESTIGATION? CUSTOMER SENT IN RMA1202123965, THE 3 PARTS WITH BLOOD. COMPLAINT NOTIFIED DATE TO BMT: 31-MAR-2026. ISSUE DESCRIPTION: INFORMATION RECEIVED FROM CUSTOMER VIA EMAIL ON 31-MAR-2026. "TODAY WE HAD 3 7FR PASSPORT STEERABLE SHEATHS THAT DID NOT WORK. THEY KINKED WHEN WE TRIED TO FLEX THEM. I THOUGHT IT WAS DUE TO OPERATOR ERROR HOWEVER WHEN YOU FLEXED THE SHEATH AS YOU ARE SUPPOSED TO DO IT FLEXED INTO A TWISTED CONFIGURATION MAKING IT UNUSABLE. INSTEAD OF 1 WE HAD TO USE 4 AND ONLY WHEN WE USED THE 7FR 17 MM ONE DID WE ACTUALLY HAVE ANY USEFUL FUNCTION. I AM NOT SURE IF THIS IS A BAD LOT OF SHEATHS, BUT THIS IS UNACCEPTABLE PERFORMANCE. IT DELAYED THE CASE BY OVER AN HOUR DUE TO THIS PROBLEM. DR. (B)(6) (SURGEON)". UPDATED INFORMATION ON 2-APR-2026: "ON THE SAME DAY 3 OTHER UNITS OF THE SAME LOT NUMBER SEEMED TO BE UNDAMAGED IN PACKAGING, BUT WHEN THEY TRIED TO DEFLECT THEM, THEY WERE NOT DEFLECTING PROPERLY EVER SO SLIGHTLY BENDING IN THE SHAFT OF TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24944758 ↗

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)