MetriQ™ Pump M00441000Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729862260), received between Mar 6, 2018 and Dec 11, 2024 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Device Displays Incorrect Message” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2024Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE PROCEDURE WAS ABORTED. A METRIQ PUMP WAS SELECTED FOR USE IN A VENTRICULAR TACHYCARDIA (VT) ABLATION PROCEDURE. THE METRIQ PUMP WAS PREPARED AND PROGRAMMED FOR THE PROCEDURE AND THE PATIENT WAS SEDATED WITH GENERAL ANESTHESIA. THE METRIQ PUMP ALARMED AND A SYSTEM FAULT ERROR MESSAGE ALONG WITH AN AUDIBLE ALARM OCCURRED. THIS OCCURRED PRIOR TO THE ABLATION CATHETER BEING INTRODUCED INTO THE PATIENT. THE METRIQ PUMP WAS POWERED CYCLED FIVE TIMES; HOWEVER, THE FAULT ERROR MESSAGE PERSISTED. THE PROCEDURE WAS ABORTED DUE TO THIS EVENT. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20904296 ↗
• MalfunctionJan 28, 2021Device Displays Incorrect Message; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE METRIQ SYSTEM WAS DISPLAYING A SYSTEM FAILURE ERROR MESSAGE AS A RESULT THE PROCEDURE CANNOT BE COMPLETED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 11245655 ↗
• MalfunctionNov 14, 2019Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS ABANDONED DUE TO A DEVICE MALFUNCTION. PRIOR TO AN ABLATION PROCEDURE, WHEN PREPARING THE METRIQ TUBING SET, THE PUMP WAS NOT ABLE TO PERFORM THE CALIBRATION PROCESS WHEN CLOSING THE COVER. THE PUMP WAS SWITCHED OFF AND ON, THE COVER WAS FULLY OPENED AND CLOSED AGAIN AND CALIBRATION WAS TRIED SEVERAL MORE TIMES, BUT THE ISSUE DID NOT RESOLVE. THE PROCEDURE WAS CANCELED, AND HAD TO BE RESCHEDULED. THERE WERE NO SERIOUS INJURIES OR ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9321138 ↗
• MalfunctionMar 28, 2019Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT A BUBBLE SENSOR FAILURE OCCURRED. OUT OF BOX FAILURE OF THE METRIQ PUMP OCCURRED, PRIOR SETUP OF THE TUBING THE BUBBLE SENSOR LED TURNED GREEN. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8459566 ↗
• MalfunctionMar 27, 2019Defective Device; Device Displays Incorrect Message; Defective Device; Device Displays Incorrect Message

  IT WAS REPORTED THAT THE PUMP GOT STUCK ON STANDBY FLOW MODE. DURING AN ABLATION PROCEDURE, THE METRIQ PUMP CONTINUALLY GOT STUCK DURING THE STAND BY FLOW. THEY MANUALLY INCREASED THE FLOW UP TO 5 ML/MIN TO CONTINUE TO FLOW. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. NO SERIOUS INJURY OR ADVERSE PATIENT EFFECTS OCCURRED. IT WAS FURTHER REPORTED THAT THE ERROR SAID "PUMP SPEED ERROR".

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8455531 ↗
• InjuryMar 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SAME CASE AS MDR ID# 2134265-2018-01569 AND 2134265-2018-01570. IT WAS REPORTED AN AIR BUBBLE WAS INTRODUCED INTO THE PATIENT¿S HEART. AN INTELLANAV MIFI XP ABLATION CATHETER WAS SELECTED FOR USE DURING AN ATRIAL FIBRILLATION PROCEDURE. HOWEVER, THE AREA OF THE HEART THAT WAS BEING TREATED WAS A LOW BLOOD FLOW AREA WHICH EQUATED TO LOW POWER DELIVERY; TO RESOLVE THIS ISSUE THE PHYSICIAN SWITCHED TO AN IRRIGATED CATHETER AND SELECTED AN INTELLANAV OI WITH A METRIQ IRRIGATION PUMP AND TUBING SET. THE CATHETER WAS PREPPED AND FLUSHED WITH NEARLY 80 ML THROUGH THE PUMP. ALMOST IMMEDIATELY AFTER ABLATION BEGAN, THE MAESTRO 4000 GENERATOR HALTED AND DISPLAYED AN ERROR MESSAGE. IN AN EFFORT TO TROUBLESHOOT THE ERROR MESSAGE, THE CATHETER WAS REPLACED WITH ANOTHER INTELLANAV OI. THE SECOND CATHETER WAS FLUSHED WITH THE PUMP FOR APPROXIMATELY 50 ML OF SALINE. HOWEVER, THE ISSUE PERSISTED. THE CATHETER WAS REMOVED FROM THE PATIENT, THE PUMP WAS POWERED OFF, AND THE CABLE BETWEEN THE PUMP AND GENERATOR WAS REPLACED WHICH RESOLVED THE ISSUE. ONCE POWER WAS TURNED BACK ON, THE PURGE BUTTON WAS HELD DOWN FOR A FEW SECONDS, STANDBY FLOW MODE WAS SELECTED AT 2 ML/MIN, AND THE PUMP WAS DEEMED TO BE

  Patient problems: Air Embolism; ST Segment Elevation

  MAUDE report 7315941 ↗

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, ar