EZ Steer DS BD7TCFJ8LRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10846835002607), received between Dec 14, 2022 and Jan 27, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (10 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2026Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH AN EZ STEER DS CATHETER AND THE TIP WAS DETACHED. INITIALLY IT WAS REPORTED THAT WEAKNESS ON THE DISTAL END OF THE PROBE THAT TENDS TO THIS KINKER. NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 05-JAN-2026 WHICH INDICATED THAT THE TIP WAS DETACHED. THE DAMAGE DID NOT RESULT IN WIRES BEING EXPOSED. THE DAMAGE DID NOT RESULT IN ANY LIFTED OR SHARP RINGS. THERE WAS NO RESISTANCE OR DIFFICULTY DURING INSERTION OR REMOVAL OF THE CATHETER. THE ISSUE WAS FOUND 5MM FROM THE DISTAL END OF THE CATHETER. THE DEVICE WAS NOT PRE-SHAPED. DESILET FEMORAL 8FR NON-PEELABLE SHEATH (ABBOTT LABORATORY FAST-CATH PART NO. 406362) USED. ADDITIONAL INFORMATION WAS RECEIVED ON 12-JAN-2026. NO PHOTO EVIDENCE FOR THIS EVENT. THE TIP BARELY HELD WHEN THE PROBE WAS REMOVED. IT DETACHED OUTSIDE THE PATIENT WHEN THE CARDIOLOGIST TOUCHED IT TO CHECK HIS INTEGRITY. THERE WAS ONLY ONE POINT OF WEAKNESS AT THE DISTAL END OF THE CATHETER. AT THE END OF THE PROCEDURE, PLICATED THE CATHETER AT THIS POINT OF WEAKNESS TO SEE AND THE DISTAL END EVENTUALLY YIELDED. THE DEFECTIVE CATHETER WENT OUT ITS PACKAGING. THE CATHETER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24191127 ↗
• MalfunctionJan 15, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH AN EZ STEER DS AND FRAGILITY WAS OBSERVED AT THE DISTAL TIP OF THE CATHETER. THE DISTAL TIP COULD EASILY BE DETACHED BY PLICATING IT. THERE WAS NO ADVERSE PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION INDICATED THAT IT IS CLEAR THAT THE CATHETER PRESENTED A CURVE AT THE DISTAL TIP LEVEL (PROBABLY MADE LIKE THIS) BUT ACCORDING TO THE SURGEON'S EXPERTISE, THIS CURVE CONSTITUTES A POINT OF WEAKNESS OF THE CATHETER WHICH DURING ABLATION, IN PARTICULAR FLUTTER, TENDS TO BEND TOWARD THE SEPTUM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24077715 ↗
• MalfunctionJan 9, 2026Material Protrusion/Extrusion; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH FOUR EZ STEER DS CATHETERS. THE PHYSICIAN OBSERVED A DEFECT AT THE PROBE TIP: INSULATION WAS MISSING THERE, LEAVING THE INTERNAL ELECTRODE VISIBLY EXPOSED, AND THE PROBE APPEARED SLIGHTLY BENT. NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 17-DEC-2025. NO PATIENT CONSEQUENCE, AS NOT USED IN THE PATIENT AS SOON AS THE DEFECT HAD BEEN DISCOVERED. ADDITIONAL INFORMATION WAS RECEIVED ON 31-DEC-2025. THE CATHETERS WERE NOT INTRODUCED INTO THE PATIENTS. THE DAMAGE FOUND WAS PRESENT WHEN THE ABLATION PROBE WAS REMOVED FROM ITS PACKAGING. THESE DEFECTS INVOLVED SEVERAL DIFFERENT BATCHES OF PROBE. THE "PROBE APPEARED SLIGHTLY BENT" ISSUE WAS ASSESSED AS NOT MDR REPORTABLE. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, WAS REMOTE. THE ISSUE OF THE "DEFECT AT THE PROBE TIP: INSULATION WAS MISSING THERE, LEAVING THE INTERNAL ELECTRODE VISIBLY EXPOSED" WAS ASSESSED AS MDR REPORTABLE UNDER THE FOUR EZ STEER DS CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24022014 ↗
• MalfunctionJan 9, 2026Material Protrusion/Extrusion; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH FOUR EZ STEER DS CATHETERS. THE PHYSICIAN OBSERVED A DEFECT AT THE PROBE TIP: INSULATION WAS MISSING THERE, LEAVING THE INTERNAL ELECTRODE VISIBLY EXPOSED, AND THE PROBE APPEARED SLIGHTLY BENT. NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 17-DEC-2025. NO PATIENT CONSEQUENCE, AS NOT USED IN THE PATIENT AS SOON AS THE DEFECT HAD BEEN DISCOVERED. ADDITIONAL INFORMATION WAS RECEIVED ON 31-DEC-2025. THE CATHETERS WERE NOT INTRODUCED INTO THE PATIENTS. THE DAMAGE FOUND WAS PRESENT WHEN THE ABLATION PROBE WAS REMOVED FROM ITS PACKAGING. THESE DEFECTS INVOLVED SEVERAL DIFFERENT BATCHES OF PROBE. THE "PROBE APPEARED SLIGHTLY BENT" ISSUE WAS ASSESSED AS NOT MDR REPORTABLE. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, WAS REMOTE. THE ISSUE OF THE "DEFECT AT THE PROBE TIP: INSULATION WAS MISSING THERE, LEAVING THE INTERNAL ELECTRODE VISIBLY EXPOSED" WAS ASSESSED AS MDR REPORTABLE UNDER THE FOUR EZ STEER DS CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24022005 ↗
• MalfunctionJan 9, 2026Material Protrusion/Extrusion; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH FOUR EZ STEER DS CATHETERS. THE PHYSICIAN OBSERVED A DEFECT AT THE PROBE TIP: INSULATION WAS MISSING THERE, LEAVING THE INTERNAL ELECTRODE VISIBLY EXPOSED, AND THE PROBE APPEARED SLIGHTLY BENT. NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 17-DEC-2025. NO PATIENT CONSEQUENCE, AS NOT USED IN THE PATIENT AS SOON AS THE DEFECT HAD BEEN DISCOVERED. ADDITIONAL INFORMATION WAS RECEIVED ON 31-DEC-2025. THE CATHETERS WERE NOT INTRODUCED INTO THE PATIENTS. THE DAMAGE FOUND WAS PRESENT WHEN THE ABLATION PROBE WAS REMOVED FROM ITS PACKAGING. THESE DEFECTS INVOLVED SEVERAL DIFFERENT BATCHES OF PROBE. THE "PROBE APPEARED SLIGHTLY BENT" ISSUE WAS ASSESSED AS NOT MDR REPORTABLE. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, WAS REMOTE. THE ISSUE OF THE "DEFECT AT THE PROBE TIP: INSULATION WAS MISSING THERE, LEAVING THE INTERNAL ELECTRODE VISIBLY EXPOSED" WAS ASSESSED AS MDR REPORTABLE UNDER THE FOUR EZ STEER DS CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24021969 ↗
• MalfunctionJan 9, 2026Material Protrusion/Extrusion; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH FOUR EZ STEER DS CATHETERS. THE PHYSICIAN OBSERVED A DEFECT AT THE PROBE TIP: INSULATION WAS MISSING THERE, LEAVING THE INTERNAL ELECTRODE VISIBLY EXPOSED, AND THE PROBE APPEARED SLIGHTLY BENT. NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 17-DEC-2025. NO PATIENT CONSEQUENCE, AS NOT USED IN THE PATIENT AS SOON AS THE DEFECT HAD BEEN DISCOVERED. ADDITIONAL INFORMATION WAS RECEIVED ON 31-DEC-2025. THE CATHETERS WERE NOT INTRODUCED INTO THE PATIENTS. THE DAMAGE FOUND WAS PRESENT WHEN THE ABLATION PROBE WAS REMOVED FROM ITS PACKAGING. THESE DEFECTS INVOLVED SEVERAL DIFFERENT BATCHES OF PROBE. THE "PROBE APPEARED SLIGHTLY BENT" ISSUE WAS ASSESSED AS NOT MDR REPORTABLE. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, WAS REMOTE. THE ISSUE OF THE "DEFECT AT THE PROBE TIP: INSULATION WAS MISSING THERE, LEAVING THE INTERNAL ELECTRODE VISIBLY EXPOSED" WAS ASSESSED AS MDR REPORTABLE UNDER THE FOUR EZ STEER DS CATHETERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24021929 ↗
• MalfunctionDec 30, 2025Manufacturing, Packaging or Shipping Problem; Material Protrusion/Extrusion; Manufacturing, Packaging or Shipping Problem; Material Protrusion/Extrusion

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH AN EZ STEER DS AND UPON REMOVING THE PROBE FROM ITS PACKAGING, THE DOCTOR NOTICED A DEFECT AT THE PROBE TIP. THE INSULATION AT THE TIP WAS MISSING, LEAVING THE INTERNAL ELECTRODE EXPOSED, AND THE PROBE ALSO APPEARED SLIGHTLY BENT. A SECOND DEVICE WAS OPENED WHICH HAD THE SAME ISSUE. THE DOCTOR USED A DIFFERENT BRAND OF PROBE (CHANGE OF DEVICE FROM THE COMPETITOR) AND USED AN ABLATION CATHETER 8 MM TO PERFORM THE SURGERY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23931369 ↗
• MalfunctionDec 26, 2025Manufacturing, Packaging or Shipping Problem; Material Protrusion/Extrusion; Material Twisted/Bent; Manufacturing, Packaging or Shipping Problem; Material Protrusion/Extrusion; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT WAS SCHEDULED FOR A CARDIAC ABLATION PROCEDURE, AND UPON REMOVING THE EZ STEER DS FROM ITS PACKAGING THE PHYSICIAN NOTICED THE INSULATION AT THE TIP WAS MISSING, LEAVING THE INTERNAL ELECTRODE EXPOSED. THE PROBE WAS ALSO SLIGHTLY BENT. A SECOND EZ STEER DS WAS OPENED AND THE SAME DEFECT WAS IDENTIFIED. A DIFFERENT, 8 MM ABLATION CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED. THERE ARE TWO REPORTS FOR THIS EVENT. THIS REPORT IS FOR THE 1ST EZ STEER DS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23898861 ↗
• MalfunctionDec 26, 2025Manufacturing, Packaging or Shipping Problem; Material Protrusion/Extrusion; Material Twisted/Bent; Manufacturing, Packaging or Shipping Problem; Material Protrusion/Extrusion; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT WAS SCHEDULED FOR A CARDIAC ABLATION PROCEDURE, AND UPON REMOVING THE EZ STEER DS FROM ITS PACKAGING THE PHYSICIAN NOTICED THE INSULATION AT THE TIP WAS MISSING, LEAVING THE INTERNAL ELECTRODE EXPOSED. THE PROBE WAS ALSO SLIGHTLY BENT. A SECOND EZ STEER DS WAS OPENED AND THE SAME DEFECT WAS IDENTIFIED. A DIFFERENT, 8 MM ABLATION CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES WERE REPORTED. THERE ARE TWO REPORTS FOR THIS EVENT. THIS REPORT IS FOR THE 2ND EZ STEER DS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23898830 ↗
• MalfunctionNov 6, 2025Detachment of Device or Device Component; Material Twisted/Bent; Detachment of Device or Device Component; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH AN EZ STEER DS CATHETER AND OBSERVED THE TIP COME OFF. THERE WAS WEAKNESS IN THE TIP OF THE PROBE WHEN THE PROBE WAS TAKEN OUT OF THE PATIENT. THE DOCTOR TOUCHED IT A LITTLE AND THE TIP CAME OFF. NO PATIENT CONSEQUENCE; HOWEVER, COULD HAVE COME OFF WITHIN THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED. THE DAMAGE DID NOT RESULT IN WIRES BEING EXPOSED. THE DAMAGE DID NOT RESULT IN ANY LIFTED OR SHARP RINGS. THERE WAS NO RESISTANCE OR DIFFICULTY DURING INSERTION OR REMOVAL OF THE CATHETER. THE ISSUE WAS FOUND 5MM FROM THE DISTAL END OF THE CATHETER. PHOTO NOT AVAILABLE. THE DEVICE WAS NOT PRE-SHAPED. THE SHEATH USED WAS THE DESILET FEMORAL 8FR NON-PEELABLE (ABBOTT LABORATORY FAST-CATH PART NO. 406362). NOTICED ON THIS NEW PROBE A WEAKNESS ON THE DISTAL END OF THE PROBE THAT TENDS TO KINK. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION OF THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THE KINK ISSUE WAS ASSESSED AS NON MDR REPORTABLE. THE POTENTIAL THAT IT COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, WAS REMOTE. THE TIP CAME OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23490197 ↗
• MalfunctionMay 19, 2025Computer Operating System Problem; Material Twisted/Bent; Computer Operating System Problem; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH EZ STEER DS FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED A BREAKAGE ON THE TIP LEAVING INTERNAL PARTS EXPOSED. BREAKAGE AT THE TIP OF THE ABLATION PROBE, DURING RADIO-FREQUENCY FLUTTER ABLATION, RESULTING IN THE RADIO-FREQUENCY GENERATOR. PROCEDURE STOPPED DUE TO IMPOSSIBILITY OF RESOLVING ABLATION GENERATOR ERROR. PERSISTENT ATRIAL FLUTTER AT END OF PROCEDURE. THE PROCEDURE COULD NOT BE COMPLETED BECAUSE THE GENERATOR COULD NOT BE RESTARTED. INFORMATION TO THE PATIENT AND THE NEED FOR REPROGRAMMING TO ABLATE HIS ATRIAL FLUTTER. NO PATIENT CONSEQUENCE REPORTED. ADDITIONAL INFORMATION INDICATED THE TRANSLATION IS CORRECT OF THE EVENT DESCRIPTION STATING, ¿BREAKAGE AT THE TIP LEVEL OF THE CATHETER¿. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION AND PER THE EVALUATION COMPLETION ON 25-APR-2025, THE ENTIRE CATHETER WAS NOT RETURNED AS ONLY THE TIP WAS RETURNED. ALSO, A BREAKAGE ON THE TIP WAS OBSERVED ABOVE THE CUT, LEAVING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22049082 ↗
• MalfunctionFeb 3, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FLUTTER PROCEDURE WITH A EZ STEER¿ DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER AND THE MEDICAL TEAM NOTED EXCESSIVE KINKING OF THE CATHETER AT THE DISTAL TIP. THIS WAS IDENTIFIED ON FLUOROSCOPY AFTER THE CATHETER HAD ENTERED THE RIGHT ATRIUM. THIS CREATED DIFFICULTY IN GETTING GOOD CATHETER CONTACT WITH TISSUE AND STABILITY. CATHETER WAS OK TO DELIVER RADIOFREQUENCY (RF) ENERGY AND NO ISSUES WITH IMPEDANCE TEMPERATURE NOTED DURING ABLATION, BUT THE KINK MADE PHYSICAL MANEUVERING OF THE CATHETER DIFFICULT. PHYSICIAN WAS ABLE TO COMPLETE THE PROCEDURE BY TAKING A STEERABLE VIZIGO SHEATH TO ADD STABILITY TO THE KINKED CATHETER, BUT THIS WOULD NOT HIS PREFERRED COURSE OF ACTION OR A USUAL PRACTICE IN HIS WORKFLOW. THERE WAS A 2-3 MINUTE DELAY WHILE PROCURING THE STEERABLE SHEATH. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. THE CATHETER KINK WAS IDENTIFIED UPON REMOVAL OF THE DEVICE. NO PATIENT CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21297828 ↗
• MalfunctionSep 3, 2024Failure to Deliver Energy; Obstruction of Flow; Material Protrusion/Extrusion; Failure to Deliver Energy; Obstruction of Flow; Material Protrusion/Extrusion

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN ABLATION PROCEDURE WITH AN EZ STEER DS CATHETER AND A PURGE ISSUE WITH THE DEVICE USED ON THE PATIENT OCCURRED. IN ADDITION, THERE WAS ALSO A SLIGHT CRACK IN THE DISTAL ELECTRODE. INCIDENT IN HEMODYNAMIC CARDIOLOGY. THE TUBING DOES NOT PURGE DESPITE SEVERAL TRIALS AND SEVERAL OPINIONS OF THE IPDES. CLINICAL CONSEQUENCE WAS CATHETER BROKE DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 19-AUG-2024. THIS WAS A CATHETER THAT MALFUNCTIONED DURING A PROCEDURE (NO LONGER DELIVERED ENERGY), WITH THE IMPRESSION OF A SLIGHT CRACK IN THE DISTAL ELECTRODE WHEN REMOVED. CONFIRMED THAT THERE WERE NO CONSEQUENCES FOR THE PATIENT. THEY SIMPLY HAD TO USE A NEW CATHETER. THIS PURGE ISSUE WAS ORIGINALLY CONSIDERED NON-REPORTABLE, HOWEVER, BWI BECAME AWARE THAT THE DEVICE WAS USED ON THE PATIENT ON (B)(6) 2024 AND HAVE REASSESSED THIS ISSUE AS REPORTABLE. IN ADDITION, ALSO PROVIDED ON (B)(6) 2024 THAT THERE WAS A SLIGHT CRACK IN THE DISTAL ELECTRODE AND HAVE ASSESSED THIS ISSUE AS REPORTABLE. THE AWARENESS DATE FOR BOTH THESE REPORTABLE ISSUES IS 19-AUG-2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20130432 ↗
• MalfunctionDec 14, 2022Signal Artifact/Noise; Break; Positioning Problem; Signal Artifact/Noise; Break; Positioning Problem

  IT WAS REPORTED THAT AN UNKNOWN PATIENT UNDERWENT AN UNKNOWN ABLATION PROCEDURE WITH A EZ STEER¿ DS BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER. THERE WAS A BULGE IN THE DISTAL PART OF THE CATHETER, WITH AN EROSION WHICH SEEMS OF THE CONDUCTOR AND AN ABNORMAL FLEXION OF THE DISTALITY DURING FLEXION. POOR QUALITY OF DISTAL SIGNAL. THE "BULGE IN THE DISTAL PART OF THE CATHETER" WAS NOT A FOREIGN MATERIAL. NO SHEATH WAS USED. IT WAS UNKNOWN IF THE PHYSICIAN FELT ANY RESISTANCE WHILE INTRODUCING OR RETRACTING THE CATHETER FROM THE SHEATH OR IF THERE WAS DIFFICULTY EXPERIENCED WHILE MANEUVERING THE CATHETER OR DURING THE WITHDRAWAL. THE CATHETER WAS PHYSICALLY DAMAGED. PROCEDURE WAS COMPLETED SUCCESSFULLY. ISSUE WAS NOT RESOLVED. NO PATIENT CONSEQUENCES WERE REPORTED. THE DAMAGE DID NOT RESULT IN WIRES BEING EXPOSED OR IN ANY LIFTED OR SHARP RINGS. BAD/PARTIAL ECG (BS AND/OR IC) IS NOT MDR-REPORTABLE. DEFLECTION ISSUE IS NOT MDR-REPORTABLE. BROKEN TIP IS MDR-REPORTABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15978983 ↗