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MetriQ™ Irrigation Tubing Set M0041170Recalls & reported problems

Boston Scientific Corporation · Open-Irrigation Tubing Set · Class 3

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Boston Scientific MetriQ irrigation tubing set is used for cardiac ablation irrigation. The reports mostly describe tubing leaks, trapped air, poor flow, residue on the device, and tip breakage. There are 41 reports, no deaths, 3 injuries, and 38 malfunctions. No recalls name this device. Reports fell from 10 to 5 in the prior 12-month periods.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
40
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 08714729862208), received between Mar 7, 2017 and Feb 13, 2026 — classified as 3 injuries, 37 malfunctions.

The most frequently reported specific device problem is “Defective Device” (10 reports).

1 other recall cover devices cleared under the same FDA submission (P150005); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Nov 2023: 1 reportsDec 2023: 1 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 1 reportsJul 2024: 0 reportsAug 2024: 1 reportsSep 2024: 1 reportsOct 2024: 0 reportsNov 2024: 2 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 2 reportsMar 2025: 0 reportsApr 2025: 2 reportsMay 2025: 0 reportsJun 2025: 1 reportsJul 2025: 2 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 1 reportsNov 2025: 1 reportsDec 2025: 1 reportsJan 2026: 1 reportsFeb 2026: 1 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Defective Device10
  • Device Contamination with Chemical or Other Material6
  • Insufficient Flow or Under Infusion6
  • Fluid/Blood Leak4
  • Material Integrity Problem4
  • Adverse Event Without Identified Device or Use Problem3
  • Device Displays Incorrect Message3
  • Material Deformation2

Patient problems

  • No Clinical Signs, Symptoms or Conditions31
  • No Consequences Or Impact To Patient4
  • Air Embolism3
  • ST Segment Elevation3
  • No Known Impact Or Consequence To Patient2
  • Cardiac Arrest1
  • Ventricular Fibrillation1
  • Ventricular Tachycardia1

Recent adverse event reports

The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 13, 2026Contamination

    IT WAS REPORTED THAT AN UNUSUAL SUBSTANCE OR RESIDUE WAS NOTED TO BE ATTACHED ON THE DEVICE. A METRIQ IRRIGATION TUBING SET WAS SELECTED FOR USE. DURING PREPARATION, AN UNUSUAL SUBSTANCE OR RESIDUE WAS NOTED TO BE ATTACHED ON THE DEVICE. ANOTHER OF THE SAME DEVICE WAS USED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24333095 ↗
  • MalfunctionJan 17, 2026No Flow

    DURING SETUP, THE TUBE WAS FLUSHED BUT THE AIR INSIDE THE TUBE WAS UNABLE TO BE REMOVED. DURING AN ABLATION PROCEDURE TO TREAT SUPRAVENTRICULAR TACHYCARDIA, A METRIQ IRRIGATION TUBING SET WAS USED. THE TUBE WAS FLUSHED DURING SETUP; HOWEVER, THE AIR WAS UNABLE TO BE REMOVED INSIDE THE TUBE. ANOTHER OF THE SAME DEVICE WAS USED AND THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24105216 ↗
  • MalfunctionDec 4, 2025Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED THAT DISTAL END OF THE IRRIGATION TUBING WAS LEAKING. DURING A 3D MAPPING PROCEDURE TO TREAT ATRIAL FIBRILLATION AND ATRIAL FLUTTER, A METRIQ IRRIGATION TUBING SET WAS USED. WHEN ABLATION WAS INITIATED, IT WAS OBSERVED THAT DISTAL END OF THE IRRIGATION TUBING WAS LEAKING. THE CATHETER WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23723167 ↗
  • MalfunctionNov 19, 2025Nonstandard Device; Nonstandard Device

    IT WAS REPORTED THAT THE TIP BROKE. DURING A PULSED FIELD ABLATION (PFA) PROCEDURE FOR PULMONARY VEIN ISOLATION (PVI), A METRIQ IRRIGATION TUBING SET WAS USED. WHILE ATTEMPTING TO INSERT THE TIP OF THE IRRIGATION TUBE INTO A 500 ML PLASTIC POLYETHYLENE FLUID PACK, THE TIP DETACHED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23593231 ↗
  • MalfunctionOct 31, 2025Defective Device; Defective Device

    IT WAS OBSERVED THAT AIR-LIKE SUBSTANCES WERE PRESENT AT THE TUBE JOINTS. DURING AN ABLATION PROCEDURE, A METRIQ IRRIGATION TUBING SET WAS USED TO TREAT ATRIAL FIBRILLATION. IT WAS OBSERVED THAT AIR-LIKE SUBSTANCES WERE PRESENT AT THE TUBE JOINTS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23437069 ↗
  • MalfunctionJul 30, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

    IT WAS REPORTED THAT THE CATHETER EXHIBITED INSUFFICIENT FLOW OR UNDER INFUSION. DURING A PULMONARY VEIN ISOLATION PROCEDURE TO TREAT THIRD-DEGREE ATRIAL FIBRILLATION IN THE LEFT ATRIUM, A METRIQ IRRIGATION TUBING SET WAS SELECTED FOR USE. ALTHOUGH THE IRRIGATION TUBE WAS CONNECTED TO THE SALINE AND PRIMING WAS ATTEMPTED, PERFUSION COULD NOT BE PERFORMED. THE TUBING WAS RECONNECTED SEVERAL TIMES, AND THE THREE-WAY STOPCOCK WAS REMOVED; HOWEVER, PERFUSION STILL COULD NOT BE ACHIEVED. NO ERROR MESSAGE WAS DISPLAYED. THE PUMP WAS NOT CONNECTED, AND THE SALINE BAG WAS MANUALLY PRESSURIZED BUT COULD NOT BE REFLUXED. THE ISSUE OCCURRED DURING PRIMING OUTSIDE THE PATIENT. THE DEVICE WAS REPLACED WITH ANOTHER OF THE SAME MODEL, WHICH RESOLVED THE ISSUE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS. THE DEVICE WAS DISCARDED BY THE FACILITY AND WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22663454 ↗
  • MalfunctionJul 9, 2025Defective Device; Defective Device

    IT WAS REPORTED THAT VISIBLE AIR WAS SEEN IN THE TUBING PAST THE PUMP. A METRIQ TUBING SET WAS USED TO TREAT ATRIAL FIBRILLATION DURING AN ABLATION PROCEDURE. WHEN THE ABLATION CATHETER WAS CONNECTED, FLUSHING WAS PERFORMED; HOWEVER, THE BUBBLES COULD NOT BE REMOVED. ADDITIONALLY, VISIBLE AIR WAS SEEN IN THE TUBING PAST THE PUMP. THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22461467 ↗
  • MalfunctionJun 4, 2025Device Displays Incorrect Message; Material Integrity Problem; Device Displays Incorrect Message; Material Integrity Problem

    IT WAS REPORTED THAT WHEN THE TUBING WAS INSERTED AND FLUSHING WAS ATTEMPTED, NO FLUID CAME OUT. DURING AN ABLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION (AFIB), A METRIQ IRRIGATION TUBING SET WAS USED. WHEN THE TUBING WAS INSERTED AND FLUSHING WAS ATTEMPTED, NO FLUID CAME OUT. IT WAS FOUND THAT THE FLUSH WAS PUSHED BACK INTO THE SALINE BAG DUE TO THE TUBING ASSEMBLY BEING REVERSED. A SMALL PART OF THE TUBING FITS IN ONLY ONE DIRECTION, WHICH CAUSED THE FLUSH INTO THE SALINE BAG INSTEAD OF PULLING IT OUT. THE TUBING SET WAS THEN REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS. THE DEVICE WAS DISPOSED OF AND WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22140475 ↗
  • MalfunctionApr 29, 2025Defective Device; Defective Device

    IT WAS REPORTED THAT SMALL AIR BUBBLES WERE OBSERVED IN THE LINE, BUT THEY WERE NOT DETECTED BY THE METRIQ DEVICE. DURING AN ABLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION (AFIB), A METRIQ IRRIGATION TUBING SET WAS SELECTED FOR USE. SMALL AIR BUBBLES WERE OBSERVED IN THE LINE, BUT THEY WERE NOT DETECTED BY THE METRIQ DEVICE. THE LINE WAS FLUSHED AND TAPPED, BUT THE BUBBLES WERE NOT REMOVED. THE TUBING WAS THEN REPLACED, BUT THE ISSUE WAS NOT RESOLVED. SUBSEQUENTLY, A PRESSURE BAG WAS USED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS. THE PRODUCT HAS BEEN DISPOSED OF AND WILL NOT BE RETURNED FOR ANALYSIS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21928715 ↗
  • MalfunctionApr 1, 2025Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

    IT WAS REPORTED THAT THE TUBING CONNECTION WAS LEAKING/KINKED. A METRIQ TUBING SET WAS SELECTED FOR USE FOR A FARAPULSE PVI PROCEDURE. THE METRIQ TUBING WAS ATTEMPTED TO BE USED WITH THE INTELLAGEN PUMP, AS THE CUSTOMER DID NOT HAVE THE CORRECT TUBING STOCKED. THEY TRIED TO RIG IT TOGETHER, BUT IT WAS LEAKING AND DID NOT CONNECT. A SMARTABLATE BSW TUBING WAS USED IN ITS PLACE AND WAS SUCCESSFUL. THEY HAVE SINCE ORDERED THE CORRECT TUBING. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLACING A NEW TUBING SUBSEQUENTLY WITH NO PATIENT COMPLICATIONS REPORTED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISPOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21742864 ↗
  • MalfunctionFeb 25, 2025Defective Device; Defective Device

    IT WAS REPORTED THAT DURING AN ELECTROPHYSIOLOGY PROCEDURE, A METRIQ IRRIGATION TUBING SET WAS SELECTED FOR USE. IT WAS OBSERVED THAT MICROBUBBLES COULD NOT BE PURGED WHEN THE AIR WAS REMOVED. DEVICE WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS. THE PRODUCT IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS AS IT WAS DISCARDED. IT WAS FURTHER REPORTED THAT THE ISSUE OCCURRED DURING PREPARATION; NO ERROR MESSAGES WERE DISPLAYED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21464868 ↗
  • MalfunctionFeb 24, 2025Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED THAT PRIOR TO AN ELECTROPHYSIOLOGY PROCEDURE, A METRIQ IRRIGATION TUBING SET WAS SELECTED FOR USE. THERE WAS A WATER LEAK FROM THE CHAMBER. THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS. THE PRODUCT IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS AS IT WAS DISCARDED AT THE FACILITY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21455017 ↗
  • MalfunctionNov 21, 2024Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

    IT WAS REPORTED THAT THE TUBING SET HAD AN INSUFFICIENT FLOW WHEN FLUSHING. DURING AN ABLATION PROCEDURE TO TREAT ATRIAL FIBRILLATION (AF), A METRIQ IRRIGATION TUBING SET WAS SELECTED FOR USE. WHEN FLUSHING, THE WATER DID NOT FLOW AS EXPECTED THROUGH THE TUBING; IT WAS SLOWER THAN EXPECTED. BELIEVING THIS POSED A RISK FOR AIR TO APPEAR THE TUBING WAS REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS. THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20748270 ↗
  • MalfunctionNov 20, 2024Defective Device; Defective Device

    IT WAS REPORTED THAT DURING A PROCEDURE, A METRIQ TUBING SET WAS SELECTED FOR USE. MICRO-BUBBLES COULD NOT BE REMOVED DESPITE FLUSHING. TUBING SET WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT COMPLICATIONS. PRODUCT WILL NOT BE RETURNED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20737751 ↗
  • MalfunctionSep 19, 2024Insufficient Flow or Under Infusion; Material Deformation; Insufficient Flow or Under Infusion; Material Deformation

    IT WAS REPORTED THAT THE METRIQ TUBING SET WAS BENT WHICH PREVENTED IRRIGATION TO FLOW. THE DEVICE WAS REPLACED WITH A NEW ONE AND PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS OCCURRED. THE DEVICE WILL NOT BE RETURNED DUE TO DISPOSAL.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20257754 ↗
  • MalfunctionAug 27, 2024Defective Device; Defective Device

    THE METRIQ OPEN-IRRIGATED TUBING SET WAS SELECTED FOR USE DURING THE PROCEDURE TO TREAT PAROXYSMAL ATRIAL FIBRILLATION. IT WAS REPORTED THAT DURING PREPARATION OUTSIDE OF THE PATIENT, THE AIR COULD NOT BE REMOVED. NO ERROR MESSAGE OCCURRED. IT WAS NOTED THAT AIR WAS VISIBLE IN THE TUBING PAST THE PUMP. TROUBLESHOOTING WAS PERFORMED BY PUSHING THE AIR QUICKLY AND TAPPING IT, BUT THE EVENT WAS NOT RESOLVED, THEREFORE, THE DEVICE WAS REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT COMPLICATIONS. THE DEVICE WILL NOT BE RETURNED AS IT HAS ALREADY BEEN DISPOSED BY FACILITY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20075682 ↗
  • MalfunctionJun 26, 2024Defective Device; Defective Device

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CATHETER MYOCARDIAL ABLATION PROCEDURE TO TREAT A SUPRAVENTRICULAR TACHYCARDIA (SVT) IN THE RIGHT ATRIUM, A METRIQ IRRIGATION TUBING SET WAS SELECTED FOR USE. EVEN AFTER OPENING A NEW DEVICE AND REMOVING THE AIR FROM THE TUBE, AIR REMAINED INSIDE THE TUBE. NO ERROR MESSAGES WERE DISPLAYED. THE AIR WAS SEEN IN THE TUBING PAST THE PUMP. TUBING SET WAS REPLACED AND THE ISSUE WAS RESOLVED. PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY WITHOUT ANY PATIENT COMPLICATIONS. DEVICE IS NOT EXPECTED TO BE RETURNED DUE TO INFECTION/CONTAMINATION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19619375 ↗
  • MalfunctionDec 26, 2023Material Integrity Problem; Material Integrity Problem

    IT WAS REPORTED THAT DURING A CATHETER ABLATION PROCEDURE TO TREAT ATRIAL TACHYCARDIA THE METRIQ TUBING SET WAS SELECTED FOR USE, THE CONNECTION PART ON THE TUBE SIDE OF THE THREE-WAY STOPCOCK WAS DAMAGED. IT WAS JUDGED THAT THE DEVICE COULD NOT BE SAFELY CONNECTED INTO THE TUBE, THE TROUBLESHOOTING WAS PERFORMED AND THE CATHETER WAS REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS NOT GOING TO BE RETURNED BECAUSE IT WAS DISCARDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18393627 ↗
  • MalfunctionNov 8, 2023Defective Device; Defective Device

    IT WAS REPORTED THAT DURING A PERCUTANEOUS MYOCARDIAL ABLATION PROCEDURE TO TREAT AN ATRIAL FIBRILLATION A METRIQ IRRIGATION TUBING SET WAS SELECTED FOR USE. THE PHYSICIAN NOTICED THAT AIR WAS GENERATED INSIDE THE TUBING AND WAS UNABLE TO PURGE IT DESPITE TAPPING OR FLUSHING. NO ERROR MESSAGE OR CODE WAS DISPLAYED. THE TUBING SET WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS NOT EXPECTED TO RETURN FOR LABORATORY ANALYSIS AS IT WAS DISPOSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18092876 ↗
  • MalfunctionOct 4, 2023Defective Device; Defective Device

    IT WAS REPORTED THAT DURING PREPARATION FOR A PULMONARY VEIN ISOLATION PROCEDURE, AN OI TUBING SET WAS SELECTED FOR USE, HOWEVER, THE DEVICE PRESENTED AN ISSUE. ONCE THE TUBING WAS LOADED INTO THE PUMP, THE TUBING SUCKED AIR IN INSTEAD OF PUSHING THE SALINE OUT. THEREFORE, IT WAS DECIDED TO REPLACE THE DEVICE, AND THE ISSUE WAS RESOLVED. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE WAS RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17866295 ↗
  • MalfunctionOct 3, 2023Defective Device; Defective Device

    IT WAS REPORTED THAT A METRIQ TUBING SET DURING PROCEDURE OUTSIDE THE PATIENT, HAD AN ISSUE REMOVING OR FLUSHING AIR OUTSIDE THE DEVICE, THIS ACTION COULD NOT BE PERFORMED. AIR WAS SEEN IN THE TUBING PAST THE PUMP. AS THE PROCEDURE COULD NOT CONTINUE THIS WAS, THE DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED WITHOUT PATIENT COMPLICATIONS. THE DEVICE WILL NOT BE RETURNED SINCE IT'S ALREADY DISCARDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17864839 ↗
  • MalfunctionMay 23, 2023Fluid/Blood Leak; Fluid/Blood Leak

    IT WAS REPORTED THAT THE TUBING SET EXHIBITED A FLUID LEAK DURING CONNECTION. DURING PREPARATION PRIOR TO SEDATION FOR A PROCEDURE A METRIQ IRRIGATION TUBING SET WAS SELECTED FOR USE. DURING CONNECTION A FLUID LEAK WAS CONFIRMED. THE TUBING SET WAS REPLACED WITH ANOTHER OF THE SAME MODEL AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. THE DEVICE IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS DUE TO DISPOSAL.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16987293 ↗
  • MalfunctionApr 4, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

    THE METRIQ IRRIGATION TUBING SET WAS SELECTED FOR USE DURING A RADIOFREQUENCY CATHETER ABLATION TO TREAT ATRIAL FIBRILLATION. IT WAS REPORTED THAT DURING PREPARATION A FOREIGN MATERIAL WHICH APPEARED TO BE A HAIR OR FIBER WAS OBSERVED ON THE DEVICE, THEREFORE, IT WAS NOT USED. THE SET WAS REPLACED WITH A NEW ONE FROM THE SAME MODEL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT PATIENT COMPLICATIONS. THE DEVICE HAS BEEN DISCARDED BY THE FACILITY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16673442 ↗
  • MalfunctionSep 15, 2022Material Integrity Problem; Material Integrity Problem

    IT WAS REPORTED THAT THE "STABBING OPENING" ON THE BACK OF THE METRIQ TUBING SET WAS SAID TO HAVE BEEN DAMAGED. IT IS UNCLEAR THE EXACT TIMING THAT IT WAS DAMAGED. SINCE IT WAS DISCOVERED DURING PREOPERATIVE PREPARATION, IT WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15431608 ↗
  • MalfunctionAug 5, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    DURING PREPARATION OF A ABLATION PROCEDURE A METRIQ IRRIGATION TUBING SET WAS SELECTED FOR USE. THERE WAS A DIRT-LIKE SUBSTANCE IN THE THREE-WAY STOPCOCK PART. THE TUBING SET WAS EXCHANGED AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15175429 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P150005. One submission often covers many models, so check the product and lot details in each record.

  • Z-0699-2019 · Nov 28, 2018 · Open, Classified
    Blazer Open-Irrigated Ablation Batch Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump

Other catheter, percutaneous, cardiac ablation, for treatment of atrial flutter devices

All catheter, percutaneous, cardiac ablation, for treatment of atrial flutter devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page