Dolphin BT G36102Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002361027), received between Nov 16, 2017 and Aug 7, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Burst Container or Vessel” (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 16, 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.

• MalfunctionAug 7, 2018Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRACHEOSTOMY, A DOLPHIN BT CIAGLIA BALLOON-ASSISTED PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET WAS USED. THE BALLOON OF THE DEVICE BURST WHILE INFLATING AT A PRESSURE OF LESS THAN 11 ATMOSPHERES (BALLOON BURST AT 10ATM) AND THEN BECAME DIFFICULT TO REMOVE. A NEW DOLPHIN SET WAS THEN USED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7757868 ↗
• MalfunctionNov 16, 2017Fluid/Blood Leak; Material Rupture; Fluid/Blood Leak; Material Rupture

  THE INTERNATIONAL CUSTOMER REPORTED THAT, WHEN THE OPERATOR INCREASED THE SODIUM CHLORIDE (NACL) PRESSURE IN THE BALLOON TO APPROXIMATELY 11 PSI, THE BALLOON PORTION OF THE DOLPHIN BT CIAGLIA BALLOON-ASSISTED PERCUTANEOUS TRACHEOSTOMY INTRODUCER DEVICE RUPTURED AFTER APPROXIMATELY 15 SECONDS. NACL LEAKED OUT OF THE BALLOON. THE OPERATOR PROCEEDED TO INSERT THE TRACHEAL CANNULA AS ORIGINALLY INTENDED, AND IT OCCURRED WITH NO PROBLEMS. AS A RESULT, THE PROCEDURE OCCURRED WITH NO PATIENT ADVERSE EVENTS OR ADDITIONAL MEDICAL INTERVENTION ON THE FIRST TRY. THE DEVICE IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7039657 ↗