Destino Reach Steerable Guiding Sheath DCR1007750Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885672007669), received between Dec 31, 2024 and Feb 7, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER STATED DESPITE BEING UNDER PRESSURIZED BAG OF SALINE, BLOOK WAS BACKFLOWING THROUGH THE FLUSH PORT (SEE ATTACHED PHOTO). BLOOD ASPIRATED AND FLUSH LINE / CATHETER FLUSHED WITH NORMAL SALINE. INCREASING PRESSURE IN BAG APPEARED TO RECTIFY THE ISSUE. THIS IS THE 3RD OCCURRENCE OF BACKFLOW/LEAKAGE REPORTED FOR THAT PARTICULAR LOT AT BASILDON, AND THE 5TH TOTAL INCIDENT. PLEASE ACKNOWLEDGE THIS NEW INCIDENT AND PROVIDE RMA TO RETURN SHEATH FOR EVALUATION. ON 30/JAN/2025: EVENT OCCURRED ON 22/JAN/2025, IN THE UNITED KINGDOM, AND DEVICE LOT NUMBER IS S9130723 (3RD INCIDENT WITH SAME SHEATH LOT NUMBER). ISSUE OCCURRED DURING A VENTRICULAR TACHYCARDIA ABLATION PROCEDURE AND WAS COMPLETED SUCCESSFULLY BY APPLYING MORE PRESSURE TO THE SALINE BAG. THERE WAS NO PATIENT HARM, NO MEDICAL OR SURGICAL INTERVENTION, AND NO PROCEDURE DELAY. PICTURE WAS PROVIDED. DEVICE IS AVAILABLE FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21337210 ↗
• MalfunctionDec 31, 2024Difficult to Advance; Difficult to Advance

  UPDATED EVENT DESCRIPTION 01/28/2025: THIS COMPLAINT IS RELATED TO: OCCLUSION (1); DILATOR WOULD NOT PASS FULLY THROUGH THE ID OF SHEATH (LOT S9298168). THERE WAS NO PATIENT INJURY INVOLVED IN THIS INCIDENT. SHEATH WAS NEVER INSERTED INTO THE PATIENT AS IT FAILED DURING PRE-PROCEDURE SETUP. IT WAS REPLACED WITH A 2ND SHEATH FROM SAME LOT WHICH WORKED FINE. THE SUBJECT SHEATH WAS RETURNED TO INTEGER (B)(4). NOTE: THIS EVENT IS NO LONGER REPORTABLE. IT WAS REPORTED DUE TO THE PREVIOUS EVENT DESCRIPTION STATED THE PATIENT HAD A STROKE. THE NEW EVENT DESCRIPTION FROM OUR CUSTOMER STATES THE PATIENT DID NOT HAVE A STROKE. OUR CUSTOMER INTIALLY REPORTED THE WRONG INFORMATION FOR THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Stroke/CVA

  MAUDE report 21047662 ↗