Reference Patch CARTO 3 CREFP6Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 20846835000129), received between Oct 19, 2022 and Nov 6, 2025 — classified as 2 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Tear, Rip or Hole in Device Packaging” (7 reports).

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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 6, 2025Expiration Date Error; Device Markings/Labelling Problem; Expiration Date Error; Device Markings/Labelling Problem

  IT WAS REPORTED THERE WERE SOME INCONSISTENCES BETWEEN THE REFERENCE PATCH CARTO 3 DEVICE AND THE PACKAGE LABEL. IT WAS REPORTED THAT WHEN THE PACKAGE WAS OPEN, IT WAS FOUND THAT THE LOT AND EXPIRATION DATE ON THE DEVICE WERE INCONSISTENT WITH THOSE ON THE PACKAGE AND THERE WERE MIXING OF EXPIRED MATERIALS. THE DEVICES WERE NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23493849 ↗
• MalfunctionNov 6, 2025Expiration Date Error; Device Markings/Labelling Problem; Expiration Date Error; Device Markings/Labelling Problem

  IT WAS REPORTED THERE WERE SOME INCONSISTENCE BETWEEN THE REFERENCE PATCH CARTO 3 DEVICE AND THE PACKAGE LABEL. IT WAS REPORTED THAT WHEN THE PACKAGE WAS OPEN, IT WAS FOUND THAT THE LOT AND EXPIRATION DATE ON THE DEVICE WERE INCONSISTENT WITH THOSE ON THE PACKAGE AND THERE WERE MIXING OF EXPIRED MATERIALS. THE DEVICES WERE NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23493847 ↗
• MalfunctionNov 6, 2025Expiration Date Error; Device Markings/Labelling Problem; Expiration Date Error; Device Markings/Labelling Problem

  IT WAS REPORTED THERE WERE SOME INCONSISTENCES BETWEEN THE REFERENCE PATCH CARTO 3 DEVICE AND THE PACKAGE LABEL. IT WAS REPORTED THAT WHEN THE PACKAGE WAS OPEN, IT WAS FOUND THAT THE LOT AND EXPIRATION DATE ON THE DEVICE WERE INCONSISTENT WITH THOSE ON THE PACKAGE AND THERE WERE MIXING OF EXPIRED MATERIALS. THE DEVICES WERE NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23493833 ↗
• MalfunctionNov 6, 2025Expiration Date Error; Device Markings/Labelling Problem; Expiration Date Error; Device Markings/Labelling Problem

  IT WAS REPORTED THERE WERE SOME INCONSISTENCES BETWEEN THE REFERENCE PATCH CARTO 3 DEVICE AND THE PACKAGE LABEL. IT WAS REPORTED THAT WHEN THE PACKAGE WAS OPEN, IT WAS FOUND THAT THE LOT AND EXPIRATION DATE ON THE DEVICE WERE INCONSISTENT WITH THOSE ON THE PACKAGE AND THERE WERE MIXING OF EXPIRED MATERIALS. THE DEVICES WERE NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23493815 ↗
• MalfunctionNov 3, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A REFERENCE PATCH CARTO 3. REFERENCE PATCHES ARRIVED WITH THE INTERNAL SEAL BREACHED. THEREFORE, FOR SAFETY, THE MEDICAL TEAM CHOSE NOT TO USE THE MATERIAL. NO RISK WAS CAUSED TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED. THEY DID NOT TAKE ANY PHOTOS AS THEY WERE IN A STERILE OPERATING ROOM. THE PRODUCT WAS DISPOSED OF ACCORDING TO LOCAL HOSPITAL PROTOCOL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23447481 ↗
• MalfunctionJun 20, 2025Tear, Rip or Hole in Device Packaging; Manufacturing, Packaging or Shipping Problem; Tear, Rip or Hole in Device Packaging; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A REFERENCE PATCH CARTO 3 AND WHEN THE MEDICAL TEAM OPENED THE OUTER BOX, THE INNER BAG WAS NOT SEALED WITH ADHESIVE AND WAS LEFT OPEN. THE REFERENCE PATCH WAS USED ON THE PATIENT BASED ON THE PHYSICIAN'S DECISION, AS IT IS NOT A STERILE PRODUCT. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22294753 ↗
• MalfunctionMar 28, 2025Tear, Rip or Hole in Device Packaging; Manufacturing, Packaging or Shipping Problem; Tear, Rip or Hole in Device Packaging; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A REFERENCE PATCH CARTO 3. WHEN THEY OPENED THE PACKAGING FOR THE PATCHES, EACH OF THE PATCHES WERE NOT SEALED. ADVISED THE CALLER TO NOT USE THE PATCH SET. NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. THEY DID NOT TAKE ANY PHOTOS OF THE OPEN PACKAGING. THE PACKAGING WAS SENT BACK BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21721810 ↗
• MalfunctionMar 27, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A REFERENCE PATCH CARTO 3. WHEN OPENED THE BOX, THE STERILE PACKAGING WAS ALREADY UNSEALED. NEW REFERENCE PATCH WAS OPENED AND USED. ISSUE OCCURRED PRE-OP. THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS. NO PATIENT CONSEQUENCE. ADDITIONAL INFORMATION RECEIVED CONFIRMED THE DEVICE WAS NOT USED ON THE PATIENT. THE PACKAGING NOT AVAILABLE SINCE THE PACKAGING WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21715687 ↗
• MalfunctionMar 4, 2025Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A CARTO® 3 SYSTEM EXTERNAL REFERENCE PATCHES AND THERE WAS REPORTS OF "CONTAMINATED MATERIAL". NO FURTHER DETAILS WERE PROVIDED REGARDING TROUBLESHOOTING OF THE ISSUE OR COMPLETION OF THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21519463 ↗
• MalfunctionJan 16, 2025Display or Visual Feedback Problem; Delivered as Unsterile Product; Display or Visual Feedback Problem; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A REFERENCE PATCH CARTO 3 AND THE MEDICAL TEAM STATED THAT THERE WAS 'CONTAMINATION' OF THE MONITORING PATCH. NO FURTHER DETAILS WERE PROVIDED SPECIFYING THE NATURE OF THE CONTAMINATION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21175310 ↗
• MalfunctionDec 10, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE AND UPON OPENING, THE SEAL PART WAS TORN. THE DEVICE WAS NOT USED ON THE PATIENT. THEY REPLACED THE REFERENCE PATCH WITH ANOTHER ONE. NO ADVERSE PATIENT CONSEQUENCE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20898501 ↗
• InjurySep 18, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION AND THE PATIENT EXPERIENCED ALLERGIC SKIN REACTION FROM THE CARTO® 3 SYSTEM EXTERNAL REFERENCE PATCHES. THE ALLERGIC SKIN REACTION REQUIRED MEDICATION. PATIENT HAD AN ALLERGIC REACTION TO ALL OF THE PATCHES (ECG REFERENCE PATCHES, INDIFFERENT ELECTRODE, AND CARTO 3 SYSTEM REFERENCE PATCHES). THE RASH WAS DISCOVERED POST PROCEDURE. THE PATIENT WAS GIVEN HYDROCORTISONE AND BENADRYL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS STABLE.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 20251301 ↗
• MalfunctionMay 15, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) PROCEDURE WITH A CARTO® 3 SYSTEM EXTERNAL REFERENCE PATCHES. WHEN THE REFERENCE PATCH PACKAGING WAS OPENED, THEY NOTICED THAT THE PATCHES WERE NOT COMPLETELY SEALED. WHEN THE PATCH WAS REPLACED, THE ISSUE RESOLVED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19321078 ↗
• MalfunctionMay 8, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE STERILIZATION POUCH OF THE CARTO® 3 SYSTEM EXTERNAL REFERENCE PATCHES WERE NOT SEALED. IT WAS REPORTED THAT THE HOSPITAL STAFF OPENED A PACKAGE OF A CARTO® 3 SYSTEM EXTERNAL REFERENCE PATCHES IN PREPARATION FOR A PROCEDURE AND FOUND THAT TWO BAGS INSIDE WERE NOT SEALED ON ONE OF THE SIDES. THE DEVICES WERE NOT USED ON ANY PATIENT. A REPLACEMENT OF THE SAME LOT WAS OPENED, AND NO PROBLEM WAS OBSERVED. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19274580 ↗
• MalfunctionMay 2, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH CARTO® 3 SYSTEM EXTERNAL REFERENCE PATCHES AND THE MEDICAL TEAM DETERMINED THAT THE PATCHES WERE CONTAMINATED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19235334 ↗
• InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem; Adverse Event Without Identified Device or Use Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN IDIOPATHIC VENTRICULAR TACHYCARDIA (IDVT) ABLATION PROCEDURE WITH A CARTO® 3 SYSTEM EXTERNAL REFERENCE PATCHES AND THE PATIENT SUFFERED CARDIAC ARREST AND POSSIBLE ANAPHYLACTIC REACTION. WHILE BEGINNING TO INTUBATE THE PATIENT THE ANESTHESIA DOCTOR PUSHED VANCOMYCIN AND THE PATIENT CODED. THE BWI REPRESENTATIVE STATED THAT THERE WERE STILL VISIBLE P WAVES AND QRS ON THE ECG BUT NO CAROTID PULSE. CHEST COMPRESSIONS WERE PERFORMED AS WELL AS 7 CARDIOVERSIONS. A LIFT TEAM WAS BROUGHT IN ON STANDBY AND THE PHARMACY CAME TO PUSH MEDS. THE PATIENT STABILIZED AND THE PULSE RETURNED, THE CASE THEN PROCEEDED WITHOUT FURTHER INCIDENT. THE PATCHES WERE THE ONLY BIOSENSE WEBSTER PRODUCT INVOLVED AT THE TIME OF THE INCIDENT. THE DOCTOR INQUIRED IF THE CARTO PATCHES COULD CAUSE ANAPHYLACTIC SHOCK. THE BWI REPRESENTATIVE REQUESTED INFORMATION ABOUT THE ADHESIVE MATERIAL ON THE PATCHES AND WAS DIRECTED TO MEDICAL AFFAIRS. THE PATCHES WERE DISCARDED AND ARE NOT AVAILABLE FOR RETURN. CONSERVATIVELY THIS EVENT WILL BE AN ADVERSE EVENT FOR CARDIAC ARREST, ANAPHYLACTIC REACTION. IT IS MOST LIKELY THAT THE VANCOMYCIN AND /OR THE ANESTHESIA MEDICATIONS THAT WER

  Patient problems: Anaphylactic Shock; Cardiac Arrest

  MAUDE report 15636615 ↗