QUATTRO® Intravascular Heat Exchange Catheter Kit Surmodics Non-Heparin IC-4593AERecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00849111075114), received between Oct 24, 2015 and Jan 19, 2016 — classified as 4 injuries, 1 malfunction.

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJan 19, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED THAT THERE HAS BEEN THREE PATIENTS WITH DEEP VEIN THROMBOSIS (DVTS) AND ONE PATIENT WITH PULMONARY EMBOLISMS (PE) USING THE ZOLL CATHETERS. THERE WAS NO PATIENT INFORMATION OR EVENT INFORMATION PROVIDED. ZOLL IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION ON THE REPORTED ISSUES. FOR REFERENCE OF RELATED EVENTS: 3010617000-2016-00027, 3010617000-2016-00059, AND 3010617000-2016-00060.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5378329 ↗
• InjuryJan 15, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED THAT THERE HAS BEEN THREE PATIENTS WITH DEEP VEIN THROMBOSIS (DVTS) AND ONE PATIENT WITH PULMONARY EMBOLISMS (PE) USING THE ZOLL CATHETERS. THERE WAS NO PATIENT INFORMATION OR EVENT INFORMATION PROVIDED. ZOLL IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION ON THE REPORTED ISSUES. FOR REFERENCE OF RELATED EVENTS: 3010617000-2016-00058, 3010617000-2016-00059, AND 3010617000-2016-00060.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5371991 ↗
• InjuryJan 15, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED THAT THERE HAS BEEN THREE PATIENTS WITH DEEP VEIN THROMBOSIS (DVTS) AND ONE PATIENT WITH PULMONARY EMBOLISMS (PE) USING THE ZOLL CATHETERS. THERE WAS NO PATIENT INFORMATION OR EVENT INFORMATION PROVIDED. ZOLL IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION ON THE REPORTED ISSUES. FOR REFERENCE OF RELATED EVENTS: 3010617000-2016-00027, 3010617000-2016-00058, AND 3010617000-2016-00059.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5371567 ↗
• InjuryJan 15, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED THAT THERE HAS BEEN THREE PATIENTS WITH DEEP VEIN THROMBOSIS (DVTS) AND ONE PATIENT WITH PULMONARY EMBOLISMS (PE) USING THE ZOLL CATHETERS. THERE WAS NO PATIENT INFORMATION OR EVENT INFORMATION PROVIDED. ZOLL IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION ON THE REPORTED ISSUES. FOR REFERENCE OF RELATED EVENTS: 3010617000-2016-00027, 3010617000-2016-00058, AND 3010617000-2016-00060.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5371553 ↗
• MalfunctionOct 24, 2015Adverse Event Without Identified Device or Use Problem

  A (B)(6) WHITE MALE WAS ENROLLED IN THE (B)(6) STUDY ON (B)(6) 2015 AT 23:00 WITH A PAST MEDICAL HISTORY OF HYPERTENSION. THE PATIENT WAS A CURRENT USER OF TOBACCO AND ALCOHOL. ON (B)(6) 2015, AT 20:53, THE PATIENT HAD A WITNESSED OUT OF OFFICE CARDIAC ARREST AT HOME. THE PATIENT DID NOT RECEIVE ANY BYSTANDER TREATMENT. EMS ARRIVED AT 21:00 AND PATIENT RECEIVED CPR AND DEFIBRILLATION. ROSC WAS ACHIEVED AT 21:21 WITH INITIAL RHYTHM OF VENTRICULAR FIBRILLATION. THE PATIENT WAS INTUBATED ON SCENE. AT ADMISSION, A PULSE RATE OF 80 BEATS PER MINUTE, BP VALUE OF 130/80 MM HG, AND RESPIRATORY RATE OF 14 BREATHS PER MIN WERE RECORDED. X-RAY HAD REVEALED A POSSIBLE PNEUMONIA DUE TO ASPIRATION. ON THE SAME DAY, IVTM QUATTRO CATHETER WAS SUCCESSFULLY INSERTED INTO THE LEFT FEMORAL VEIN AT 23:00 AND COOLING WAS INITIATED AT 23:20. REWARMING PROCEDURE BEGAN ON (B)(6) 2015 AT 01:00. CATHETER WAS REMOVED ON (B)(6) 2015 AT 16:30. ON (B)(6) 2015, AT 00:00, 2 DAYS AFTER INITIATION OF COOLING PROCEDURE, THE DAY AFTER REWARMING PROCEDURE WAS INITIATED, DURING NORMOTHERMIA, THE PATIENT EXPERIENCED SYMPTOMS OF URINARY TRACT INFECTION. THE PATIENT RECEIVED TREATMENT WITH MEDICATIONS. ADDITIONALLY, THE PA

  Patient problems: Death; Thrombus

  MAUDE report 5173455 ↗