NA 2037A (UDI 00763000306496)Recalls & reported problems
Medtronic, Inc. · BOX 2037A AUTO CONNECTION BOX MDR · Class 3
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000306496), received between Apr 8, 2026 and Apr 8, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Protective Measures Problem” (1 report).
2 other recalls cover devices cleared under the same FDA submission (P020045); 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.
Reports received per month
Most reported problems
Device problems
- No Apparent Adverse Event1
- Protective Measures Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryApr 8, 2026Protective Measures Problem; No Apparent Adverse Event
IT WAS REPORTED THAT DURING A CRYO ABLATION PROCEDURE, N-002 SYSTEM NOTICE OCCURRED. THE USER WAS UNABLE TO REMOVE THE COAX CAP AT THE TIME OF THE CALL, WHICH PREVENTED VERIFICATION OF A POSSIBLE COAX PORT OBSTRUCTION. THE CASE WAS ABORTED WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. IT WAS REPORTED THAT 12 OF 14 ABLATION APPLICATIONS WERE ¿PERFECT,¿ AND THE N-002 OCCURRED ON APPLICATIONS 13 AND 14. A SUBSEQUENT INSPECTION FOUND THE COAX PORT TO BE CLEAR OF OBSTRUCTIONS, AND PHM RECORDS WERE RECEIVED AND REVIEWED. TEST ABLATIONS WERE REQUESTED/PERFORMED, DURING WHICH A FAULTY AUTO CONNECTION BOX WAS REPORTED AND THE CATHETER WAS NOT RECOGNIZED; REPLACING THE AUTO CONNECTION BOX RESOLVED THE CATHETER RECOGNITION ISSUE, AND TEST ABLATIONS WERE PROCEEDING. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24820959 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P020045. One submission often covers many models, so check the product and lot details in each record.
- Z-2777-2015 · Sep 1, 2015 · TerminatedMedtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac ablation procedures.
- Z-1452-06 · Aug 4, 2006 · Terminated7F Freezor Cardiac Cryoablation catheter, REF # 207F1. CryoCath Technologies Inc.
Other Cardiac ablation percutaneous catheter devices
- THERMOCOOL SMARTTOUCH SF D134805Biosense Webster Inc · Cardiac ablation percutaneous catheter1 recall176 deaths4,106 reports
- THERMOCOOL SMARTTOUCH SF D134804Biosense Webster Inc · Cardiac ablation percutaneous catheter44 deaths784 reports
- THERMOCOOL SMARTTOUCH SF D134801Biosense Webster Inc · Cardiac ablation percutaneous catheter15 deaths608 reports
- ThermoCool SmartTouch D132705Biosense Webster Inc · Cardiac ablation percutaneous catheter25 deaths574 reports
- THERMOCOOL SMARTTOUCH SF D134702Biosense Webster Inc · Cardiac ablation percutaneous catheter19 deaths366 reports
- THERMOCOOL SMARTTOUCH SF D134701Biosense Webster Inc · Cardiac ablation percutaneous catheter11 deaths278 reports
- ThermoCool SmartTouch D133602Biosense Webster Inc · Cardiac ablation percutaneous catheter8 deaths225 reports
- SMARTABLATE SAT001Biosense Webster Inc · Cardiac ablation percutaneous catheter185 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.