CoolFlow CFT001Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10846835000016), received between Jul 22, 2016 and Dec 8, 2018 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (3 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.

• MalfunctionDec 8, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A COOLFLOW TUBING SET. DURING SET-UP, FOREIGN MATERIAL WAS NOTICED ON THE TIP OF THE TUBING BEFORE USE. THE TUBING WAS REPLACED AND THE PROCEDURE CONTINUED WITHOUT PATIENCE CONSEQUENCE. ADDITIONAL INFORMATION HAS BEEN RECEIVED AND IT CONFIRMED THAT THE TUBING WAS NOT USED IN THE PROCEDURE. THE FOREIGN MATERIAL ON THE TIP OF THE TUBING WAS ASSESSED AS A REPORTABLE ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8144736 ↗
• MalfunctionAug 31, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH A COOLFLOW TUBING SET AND DURING SETUP, DIRT WAS SEEN IN THE TUBE. THE TUBING SET WAS CHANGED, AND THE ISSUE RESOLVED. THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCE. THIS EVENT HAS BEEN ASSESSED AS A REPORTABLE MALFUNCTION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7840029 ↗
• MalfunctionJul 18, 2017Failure to Prime; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE FOR ATRIAL FIBRILLATION WITH A COOLFLOW TUBING SET WHERE FOREIGN MATERIAL WAS FOUND INSIDE THE TUBE. DURING THE PROCEDURE, AFTER CONNECTING THE CATHETER TO THE TUBING SET, THE PHYSICIAN ATTEMPTED TO PRIME THE TUBING. AT THIS TIME, A FOREIGN SUBSTANCE WAS SEEN IN THE TUBE. THE TUBING SET WAS EXCHANGED FOR ANOTHER, AND THE PROCEDURE CONTINUED WITHOUT PATIENT CONSEQUENCE. FOREIGN MATERIAL INSIDE A TUBING SET CAN POTENTIALLY CAUSE EMBOLISM OR STROKE. AS A RESULT, THIS EVENT IS MDR REPORTABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6721757 ↗
• MalfunctionJul 22, 2016Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A COOLFLOW TUBING SET. BEFORE SETTING THE TUBE, IT WAS FOUND THAT THERE WAS RED BLOB IN THE TUBE OF THE CONNECTION SIDE AT T SHAPE STOPCOCK. IT SEEMS THAT THE RED INK WAS ADHERED WHICH WAS EMBLAZONED ON THE T SHAPE STOPCOCK. THE ISSUE WAS RESOLVED BY CHANGING THE TUBING SET TO ANOTHER ONE. THE PROCEDURE WAS COMPLETED WITH NO PATIENT CONSEQUENCE. SINCE THERE WAS FOREIGN MATERIAL FOUND INSIDE THE TUBING, THIS ISSUE HAS BEEN ASSESSED AS A REPORTABLE MALFUNCTION AS IT CAN CAUSE EMBOLISM OR STROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5817753 ↗

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