SOLO-TRAK®-KR 6207BTK-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00681490142939), received between Sep 19, 2018 and Jun 20, 2022 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Material Integrity Problem” (4 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 20, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE THE DILATOR OF AN INTRODUCER DID NOT ENTER THE VEIN PROPERLY. IT WAS ALSO REPORTED THAT THE INTRODUCER COULD NOT BE INSERTED INTO THE VEIN WITH THE OUTER SHEATH AND DILATOR SET AGAIN AFTER VENOUS EXPANSION. IT WAS ALSO REPORTED THAT SLIGHT REVERSE PEELING ON THE TIP OF THE OUTER SHEATH WAS NOTED WHEN THE INTRODUCER WAS REMOVED FROM THE VEIN. THE INTRODUCER WAS ATTEMPTED/NOT USED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14742948 ↗
• InjuryJan 26, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERFORATION DURING THE IMPLANT PROCEDURE. IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD WAS ON THE CONTRALATERAL SIDE OF THE SUPERIOR VENA CAVA (SVC) AND HAD PROTRUDED INTO THE CHEST CAVITY, WHICH WAS CONFIRMED BY X-RAY AND COMPUTERIZED TOMOGRAPHY (CT). THE PATIENT WAS TRANSFERRED WITH INTRODUCERS IN PLACE AND EMERGENCY HEMOSTASIS WAS PERFORMED. THE INTRODUCER WAS EXPLANTED AND THE RA LEAD WAS EXPLANTED AND REPLACED UNDER GENERAL ANESTHESIA. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Cardiac Perforation

  MAUDE report 11229990 ↗
• MalfunctionMar 2, 2020Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE INTRODUCER WAS SPLIT INTO FINE LAYERS. THE INTRODUCER WAS NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9774092 ↗
• MalfunctionOct 22, 2019Material Integrity Problem; Material Integrity Problem

  IT WAS FURTHER REPORTED THAT ONLY THE RIGHT VENTRICULAR (RV) LEAD DISLODGED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9218010 ↗
• MalfunctionSep 16, 2019Break; Break

  IT WAS REPORTED THAT, DURING PREPARATION, THE TIP OF THE INTRODUCER WAS FRAYED. THE INTRODUCER WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9069149 ↗
• MalfunctionAug 30, 2019Accessory Incompatible; Break; Accessory Incompatible; Break

  IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE THE GUIDEWIRE DID NOT GO THROUGH THE PUNCTURE NEEDLE OF THE INTRODUCER. IT WAS NOTED THERE WAS PRESUMABLY AN ANOMALY OF THE JOINT OF THE NEEDLE AND THE PLASTIC. IT WAS ALSO REPORTED THERE WAS A LOOSE/ DETACHED PART. THE INTRODUCER WAS REMOVED AND ANOTHER PRODUCT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8950098 ↗
• MalfunctionJul 9, 2019Use of Device Problem; Material Integrity Problem; Use of Device Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE DIFFICULTY WAS ENCOUNTERED IN INSERTING THE SHEATH. INSERTION WAS REPEATEDLY ATTEMPTED, AND AS A RESULT OF THAT, THE TIP BECAME TO HAVE FINE SPLITS. THE PRODUCT WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8770640 ↗
• InjuryOct 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED A PNEUMOTHORAX AFTER THE LEAD IMPLANT. THE PATIENT¿S SYMPTOMS WERE STABLE. THEREFORE, NO ACTIONS WERE TAKEN. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Pneumothorax

  MAUDE report 8005374 ↗
• MalfunctionSep 19, 2018Break; Break

  IT WAS FURTHER REPORTED THAT THE TIP OF THE SYRINGE WAS DAMAGED. THE NOTED DAMAGE WAS THE TIP WAS PARTIALLY SEPARATED FROM THE BODY OF THE SYRINGE. DESPITE NOTED SYRINGE DAMAGE, AN ATTEMPT TO USE WAS MADE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7891446 ↗