MetriQ™ Pump M0044100R0Recalls & reported problems
Boston Scientific Corporation · Irrigation Pump · Class 3
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08714729862123), received between Nov 13, 2019 and Feb 27, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Device Displays Incorrect Message” (2 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Device Displays Incorrect Message2
- Air/Gas in Device1
- Intermittent Communication Failure1
- Nonstandard Device1
- Unexpected Shutdown1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 27, 2026Nonstandard Device; Intermittent Communication Failure; Air/Gas in Device
NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. IT WAS REPORTED THAT THE METRIQ PUMP DISPLAYED THE ERROR MESSAGE "CHECK PUMP", WHILE THE MAESTRO SYSTEM DISPLAYED THE ERROR MESSAGES "BUBBLE DETECTED", "CHECK STANDBY FLOW", AND "SYSTEM FAULT". CONSEQUENTLY, THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. A MAESTRO 4000 CONTROLLER AND A METRIQ PUMP WERE SELECTED FOR USE. DURING PREPARATION, AFTER THE PATIENT WAS SEDATED, THE METRIQ PUMP DISPLAYED THE ERROR MESSAGE "CHECK PUMP". AT THE SAME TIME, THE MAESTRO DISPLAYED THE ERROR MESSAGES "BUBBLE DETECTED", "CHECK STANDBY FLOW", AND "SYSTEM FAULT". CONSEQUENTLY, THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. BOTH DEVICES ARE EXPECTED TO BE RETURNED FOR ANALYSIS. THIS IS BEING REPORTED FOR CANCELLATION OF THE PROCEDURE POST-SEDATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24475229 ↗MalfunctionJun 26, 2023Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem; Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem
THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER SEDATION. IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT A VENTRICULAR TACHYCARDIA (VT), A METRIQ PUMP AND AN INTELLANAV STABLEPOINT CATHETER WERE SELECTED FOR USE. HAD SEVERAL ERROR MESSAGES AND THEY APPEARED MULTIPLE TIMES FROM THE METRIQ PUMP: TEMPERATURE DROP, COMMUNICATION AND OCCLUSION. SOME OF THE TROUBLESHOOTING STEPS TAKEN INCLUDE PUSHING ON THE ALARM BUTTONS, TURNING PUMP AND MAESTRO OFF/ON, OPENING THE PUMP DOOR AND RE-CALIBRATE. TAKING OUT THE CATHETER AND FLUSH WITH HIGH SPEED/TURN ON LOW DRIP RATE AND THEN REINTRODUCE. HAD TO DO IT SEVERAL TIMES BECAUSE THE ERRORS REAPPEARED AFTER SOME TIME. ONLY THE OCCLUSION ERROR COULD NOT BE RESOLVED. THE PHYSICIAN DID NOT WANT TO USE A NEW CATHETER TO RESOLVE THE ISSUE. THE PROCEDURE WAS ALREADY TAKING A LONG TIME SO IT WAS CANCELLED. PATIENT WAS SEDATED WITH GENERAL ANESTHESIA. THE PUMP WAS RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17203986 ↗MalfunctionMay 4, 2023Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem; Device Displays Incorrect Message; Adverse Event Without Identified Device or Use Problem
THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER SEDATION. IT WAS REPORTED THAT A METRIQ PUMP WAS SELECTED FOR USE. DURING A PROCEDURE AN ERROR "P07 - PUMP SPEED ERROR" OCCURRED. THE ERROR WAS UNABLE TO BE RESOLVED FOLLOWING REPLACEMENT OF THE TUBING SET. THE PROCEDURE WAS CANCELLED. THE PUMP IS EXPECTED TO BE RETURNED FOR ANALYSIS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16869615 ↗MalfunctionNov 13, 2019Unexpected Shutdown; Unexpected Shutdown
IT WAS REPORTED THAT THE PROCEDURE WAS ABORTED DUE TO A DEVICE MALFUNCTION. IT WAS REPORTED THAT THE MERITQ PUMP IS TURNING ON AND OFF SUDDENLY. THE PROCEDURE WAS ABANDONED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9315110 ↗
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, ClassifiedBlazer Open-Irrigated Ablation Batch Catheter Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, ar
Other catheter, percutaneous, cardiac ablation, for treatment of atrial flutter devices
- QDOT MICRO D139505Biosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter27 deaths915 reports
- IntellaNav MiFi™ Open-Irrigated M004PMR96200Boston Scientific Corporation · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter4 deaths269 reports
- QDOT MICRO D139504Biosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter7 deaths138 reports
- Sphere-9™ Catheter AFR-00001Medtronic, Inc. · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter1 recall5 deaths77 reports
- QDOT MICRO D139401Biosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter2 deaths114 reports
- NaviStar ThermoCool NI75TCDHBiosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter111 reports
- NaviStar RMT ThermoCool NR7TCSIYBiosense Webster Inc · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter9 deaths103 reports
- IntellaNav MiFi™ Open-Irrigated M004PMR9620K20Boston Scientific Corporation · catheter, percutaneous, cardiac ablation, for treatment of atrial flutter78 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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