CarboJet® CO2 Bone Lavage System 25-200-0244Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00898142001517), received between Aug 30, 2015 and Aug 30, 2015 — classified as 1 injury.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjuryAug 30, 2015Insufficient Device Problem Information

  A LITERATURE REVIEW WAS CONDUCTED AS PART OF THE INITIAL INVESTIGATION OF THE EVENT REPORTED IN MDR 2027148-2015-00002. DURING A SUBSEQUENT LITERATURE REVIEW ON 08/04/2015, A SIMILAR ADVERSE EVENT (OCCURRING IN SPAIN) INVOLVING CARBOJET WAS FOUND IN A CASE REPORT THAT WAS PUBLISHED IN 2012 IN A SPANISH-LANGUAGE ANESTHESIOLOGY JOURNAL. IT WAS ALSO FOUND THAT THE SAME CASE (SAME PATIENT, SAME HOSPITAL) WAS REDUNDANTLY PUBLISHED IN 2014 IN A SPANISH-LANGUAGE ORTHOPEDIC JOURNAL. ACCORDING TO THESE LITERATURE REPORTS, THE CASE INVOLVED AN (B)(6) YEAR OLD PATIENT WHO EXPERIENCED CARDIOPULMONARY ARREST (CPA) DURING CEMENTED HIP HEMIARTHROPLASTY AND REQUIRED CARDIOPULMONARY RESUSCITATION (CPR). THE VENTRICULAR FIBRILLATION AND CPA LASTED A FEW SECONDS. THE PATIENT'S HEARTBEAT RETURNED TO NORMAL AFTER CPR AND THE SURGERY WAS STOPPED. THIS COMPLICATION WAS REPORTED TO HAVE OCCURRED IMMEDIATELY AFTER USING CARBOJET AND WAS ATTRIBUTED TO GAS EMBOLISM ONCE OTHER ENTITIES WERE RULED OUT. THE PATIENT WAS TRANSFERRED TO THE ICU FOR 24 HOURS WHERE LABORATORY TESTS WERE FOUND TO BE NORMAL WITH NO INCREASE OF CARDIAC ENZYMES. THE PATIENT WAS DISCHARGED TO THE TRAUMA DEPARTMENT AND REMAINED STABLE AND

  Patient problems: Embolism

  MAUDE report 5041420 ↗