CoolFlow CFP002Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10846835000085), received between Mar 12, 2018 and Dec 16, 2020 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Improper Flow or Infusion” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (P990071); they may or may not involve this specific model.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 16, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A (B)(6) FEMALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE ON (B)(6) 2020 WITH A COOLFLOW® IRRIGATION PUMP AND SUFFERED ACUTE PULMONARY EDEMA. DURING THE PROCEDURE, THE CABLE WOULD NOT ALLOW THE CATHETER TO ZERO. A NEW CABLE PASSED OFF, AND THE CATHETER WAS ABLE TO BE ZEROED. CASE CONTINUED WITHOUT FURTHER ISSUES. A TOTAL OF 87 RADIOFREQUENCY (RF) APPLICATIONS WERE DONE. NO IMMEDIATE PATIENT CONSEQUENCES WERE REPORTED. SAME DAY, POST-PROCEDURE, THE PATIENT DEVELOPED ACUTE PULMONARY EDEMA (AE1) AND WAS ADMITTED. UNSPECIFIED MEDICATION WAS ADMINISTERED. DC CARDIOVERSION WAS PERFORMED. PROLONGED HOSPITALIZATION WAS REQUIRED. ISSUE WAS RESOLVED, THE PATIENT WAS DISCHARGED ON (B)(6) 2020. THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS MODERATE IN SEVERITY, SERIOUS, UNLIKELY RELATED TO THE STUDY DEVICE (QDOT MICRO¿ CATHETER), NOT RELATED TO THE STUDY DEVICE (NMARQ¿ MULTI-CHANNEL RF GENERATOR SW V3.0.1), UNLIKELY RELATED TO THE STUDY DEVICE (NMARQ¿ MULTI-CHANNEL RF GENERATOR SW V3.0.6), NOT RELATED TO THE STUDY DEVICE (TX ECO EXT INTERFACE CABLE (D-1357-03-SI), NOT RELATED TO THE STUDY DEVICE (TX ECO CABLE DONGLE (EM-5050-055F), NOT RELATED

  Patient problems: Pulmonary Edema

  MAUDE report 11024566 ↗
• MalfunctionJun 21, 2019Improper Flow or Infusion; Improper Flow or Infusion

  EVENT DESCRIPTION: DURING AN IDE (QDOT) CLINICAL STUDY SPONSORED BY BIOSENSE WEBSTER, INC. DURING AN ATRIAL FIBRILLATION (AFIB) PAROXYSMAL PROCEDURE WITH A COOLFLOW® IRRIGATION PUMP, A HIGH FLOW RATE ACTIVATION PROBLEM WITH ABLATION MALFUNCTION OCCURRED. IT WAS REPORTED THAT WHEN USING Q MODE WITH THE COOLFLOW® IRRIGATION PUMP, IT WOULD NOT SWITCH TO HIGH IRRIGATION. THE MAXIMUM TEMPERATURE WAS DECREASED AND THE POWER WAS INCREASED TO 35 WATTS; HOWEVER, THE ISSUE REMAINED. THE CASE WAS COMPLETED SUCCESSFULLY HAVING REDUCED POWER BEING DELIVERED TO THE CATHETER. THERE WAS NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON THE EVENT STATING THAT THE PUMP DID NOT SWITCH TO HIGH FLOW WHEN THE ABLATION WAS INITIATED. THE COOLFLOW® IRRIGATION PUMP DID NOT DISPLAY AN ERROR AND CONTINUED ABLATING AT A LOWER FLOW. THE ISSUE OF HIGH FLOW RATE ACTIVATION PROBLEM WITH ABLATION WAS ASSESSED AS A REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8723370 ↗
• MalfunctionJul 18, 2018Fail-Safe Did Not Operate; Fail-Safe Did Not Operate

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A COOLFLOW® IRRIGATION PUMP AND ¿AIR BUBBLES UNDETECTED¿ EVENT OCCURRED. THERE WERE NO PATIENT CONSEQUENCES. DURING THE PROCEDURE, BUBBLES WERE NOT DETECTED. TUBING WAS FLUSHED AND RECONNECTED AND THE ISSUE PERSISTED. TUBING WAS CHANGED TWO (1) TIMES AND THE ISSUE PERSISTED. SALINE WAS CHANGED AND THE ISSUE PERSISTED. PUMP SENSOR WAS WIPED AND THE ISSUE PERSISTED. ABLATION CATHETER (UNSPECIFIED) WAS REPLACED WITH AN ABLAZE ABLATION CATHETER AND THE ISSUE RESOLVED. PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCES. TUBING WAS FLUSHED PRIOR TO USE ON THE PATIENT. ISSUE OCCURRED DURING FLUSHING. THERE IS NO INFORMATION REGARDING IF BUBBLE MOVEMENT WAS DETECTED. THERE IS NO INFORMATION REGARDING IF BUBBLES WERE DETECTED AFTER PASSING THROUGH THE PUMP SENSOR. NO ERROR CODES POPULATED. NO ALARMS SOUNDED. THERE IS NO PRODUCT INFORMATION FOR THE INITIAL ABLATION CATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7699575 ↗
• MalfunctionMar 12, 2018Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A COOLFLOW® IRRIGATION PUMP. IT WAS NOTED THAT THE FLOW RATE WAS LOW WHEN FIRST FLUSHING WAS CONDUCTED. THEY DESCRIBED THE ISSUE AS INSTEAD OF FLOWING LIKE A SHOWER, IT WAS A CLOUDY FLOW. THE ISSUE IMPROVED A LITTLE BY REBOOTING THE SYSTEM AND THE PROCEDURE WAS CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED. AFTER THE PROCEDURE, WHEN FLUSHING WAS CONDUCTED AGAIN, IT WAS STATED THAT THERE WAS A TIME LAG OF SEVERAL SECONDS. ADDITIONAL INFORMATION WAS RECEIVED ON THE EVENT. THE RESPONSE RECEIVED CONFIRMED THAT NO ERROR/WARNING MESSAGE WAS DISPLAYED ON THE SYSTEM. IT ALSO CONFIRMED THAT THE SYSTEM ALLOWED THE ABLATION WHEN THE ISSUE OCCURRED. SINCE THERE WAS NO ERROR/WARNING MESSAGE WHEN THE IRRIGATION PUMP WAS DELIVERING LOW FLOW DURING THE ABLATION, THIS EVENT WAS ASSESSED AS A REPORTABLE MALFUNCTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7333228 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P990071. One submission often covers many models, so check the product and lot details in each record.

• Z-0058-2018 · Sep 6, 2017 · Terminated
  THERMOCOOL SF NAV Catheters Model Numbers - BNI35FJCT, BNI35DFCT, D-131503-S, D-131504-S
• Z-3178-2011 · Jul 7, 2011 · Terminated
  STOCKERT 70 Radio Frequency Generator, Catalog Number 57001 Indicated for use with a Biosense Webster, Inc. diagnostic/ablation deflectable tip catheter to deliver radio frequenc
• Z-1328-04 · Jul 16, 2004 · Terminated
  Stockert 70 Radio Frequency Ablation Generator