Destino Reach Steerable Guiding Sheath DCR0857722Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885672007232), received between Jun 15, 2018 and Jun 15, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Air Leak” (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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 15, 2018Air Leak; Air Leak

  THE CUSTOMER REPORTED AT THE BEGINNING OF THE PVI PROCEDURE, THE PHYSICIAN DETECTED ST ELEVATION IN THE SURFACE ECG DURING THE USE OF DESTINO REACH SHORTLY AFTER TRANSSEPTAL PUNCTURE. ACCORDING TO THE PHYSICIAN, THIS ST ELEVATION IS DUE TO AN AIR EMBOLISM THROUGH THE STEERABLE SHEATH. THE AIR ENTRY ITSELF WAS NOT DIRECTLY OBSERVED OR NOTICED. DESTINO HAS BEEN FLUSHED AND ASPIRATED. AS ST ELEVATION HAS BEEN OBSERVED AN ABLATION CATHETER WAS ALREADY IN THE SHEATH (BIOSENSE WEBSTER THERMOCOOL SMARTTOUCH SF WITH 2ML/H ACTIVE FLUSHING). ST ELEVATION DISAPPEARED AFTER ONE MINUTE HYPERSTIMULATION OF PATIENT. THE PATIENT WAS NOT SUBJECTED TO PROCEDURES WHICH MIGHT HAVE DAMAGED THE DEVICE, AND THE EVENT DID NOT CAUSE AN ADVERSE CHANGE TO THE PATIENT'S CONDITION.

  Patient problems: Air Embolism; No Known Impact Or Consequence To Patient; Non specific EKG/ECG Changes

  MAUDE report 7607334 ↗