SenSight™ B31030 (UDI 00763000426361)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000426361), received between Sep 13, 2021 and Mar 19, 2026 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Mar 17, 2023Open, Classified

   Medtronic has received reports of SenSight Extension Tunneler kits that contain dual carriers with have been machined on only one side. As a result, the dual carrier cannot be used to pass two extensions simultaneously.

   Z-1408-2023 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2026Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT WHILE PULLING THE TUNNELER FROM CHEST TO SKULL POCKET WITH DUAL EXTENSION CARRIER, THERE WAS SIGNIFICANT BLEEDING FROM NECK/EXTENSION TRACT TO CHEST POCKET. IT WAS NOTED THAT THE TUNNELING FROM SKULL TO CHEST WAS DIFFICULT AND TIGHT. IT WAS THEN NOTED THAT THE PULLING OF TUNNELER WITH EXTENSION CARRIER AND EXTENSION TO SKULL FROM CHEST WAS DIFFICULT AS WELL. ONCE, THE EXTENSIONS WERE PULLED TO THE SKULL SUBGALEAL POCKET FROM THE CHEST SUBCLAVICULAR POCKET, BLEEDING WASNOTICED COMING FROM THE EXTENSION NECK TRACT TO THE CHEST POCKET. THE PHYSICIAN THEN HAD THE RESIDENT HOLD PRESSURE ON NECK TO STOP THE BLEEDING WHILE HE HAD A GEN SURGERY CONSULT COME INTO ROOM TO ADVISE. HE FELT THAT THE BLEEDING WAS VENOUS IN NATURE AND WOULD CHECK BACK IN 40 MINUTES TO ADVISE. THE ANESTHESIOLOGIST THEN ADMINISTERED 350 MG. TXA FOR BLEEDING AND COMPRESSION WAS RESUMED ON NECK AREA. THE DURATION OF TIME FOR COMPRESSION AT THIS TIME WAS 10 MINUTES AND PRESSURE ON NECK WAS HELD FOR ANOTHER 20 MINUTES AFTER ADMINISTRATION OF FIRST DOSE OF TXA. AT THE 30 MINUTE MARK, HCP ADVISED THAT FLO SEAL BE PUSHED UP TRACT FROM CHEST POCKET AND THEN PRESSURE BE RESUMED TO NECK. AT ABOUT 40 MINU

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24639870 ↗
• MalfunctionOct 15, 2025Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE, IT WAS OBSERVED THAT THE TUNNELER EXHIBITED STRIPPED THREADS AND IT WAS NOT POSSIBLE TO ATTACH ANY OF THE TIPS OR CARRIERS AND THEREFORE NOT USED ON THE PATIENT. THE ISSUE WAS RESOLVED BY REPLACING THE TUNNELER WITH ANOTHER ONE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. (B)(6) 2025 (B)(6) (REP): NO NEW INFORMATION (B)(6) 2025 E1 (REP): ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP) THAT THE EXPERIENCED SURGICAL TECH TRIED TO ATTACH ONE OF THE TIPS AND WOULD NOT SCREW ON. THEY TRIED ALL THE TIPS AND CARRIERS WITH NO SUCCESS. (B)(6) 2025 (B)(6) (REP): NO NEW INFORMATION (B)(6) 2025 (B)(6) (REP): NO NEW INFORMATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23304181 ↗
• MalfunctionAug 14, 2025Break; Break

  IT WAS REPORTED THAT THE CAUSE OF THE ISSUE WAS NOT DETERMINED. EXTENSIONS WERE PULLED OUT WITHOUT THE TUNNELLER, AND THE BROKEN PART OF THE TUNNELLER WAS REMOVED WITH AN INCISION. THE TUNELLIZER BROKE IN TWO AT THE TIME OF REMOVAL, MORE PRECISELY DURING THE PASSAGE OF THE EXTENSIONS IN THE RETROAURICULAR PATH TO THE SUBCLAVICULAR REGION. THIS RUPTURE REQUIRED SIGNIFICANT TRACTION ON THE EXTENSIONS TO RETRIEVE THEM, AS WELL AS AN ADDITIONAL CERVICAL INCISION TO EXTRACT THE METAL FRAGMENT THAT REMAINED TRAPPED UNDER THE SKIN. THE STANDARD PROCEDURE IS TO PERFORM TUNNELING FROM THE RETROAURICULAR INCISION (ABOVE THE EAR) TO THE SUBCLAVICULAR COMPARTMENT TO RECEIVE THE PACEMAKER. THE SURGEON FIRST PERFORMS THIS JOURNEY WITH A THIN TIP ADAPTED TO THE TUNELLIZER, IN PARTICULAR BECAUSE OF THE PRESENCE OF A VOLUMINOUS EXTERNAL JUGULAR VEIN IN THIS PATIENT. ONCE THE TUNNEL HAS BEEN CREATED, THE INITIAL TIP IS REPLACED BY THE ONE USED TO ATTACH THE TWO EXTENSIONS, THEN THE TUNERIZER IS REMOVED IN THE OPPOSITE DIRECTION, BRINGING THE EXTENSIONS BACK TO THE RETROAURICULAR INCISION. HOWEVER, DURING THIS WITHDRAWAL PHASE, STRONG RESISTANCE WAS ENCOUNTERED AT THE CERVICAL LEVEL, LEADING TO THE F

  Patient problems: Confusion/ Disorientation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22806981 ↗
• MalfunctionAug 8, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE DEVICE WAS USED TO TUNNEL AND THEY WERE UNABLE TO UNSCREW THE TOP PART OF THE INSERT EXTENSION. THEY TRIED DIFFERENT TOOLS (PLIERS) BUT WERE UNABLE, SO THEY OPENED A NEW PRODUCT AND FINISHED THE PROCEDURE. THE ISSUE WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22755067 ↗
• MalfunctionFeb 16, 2023Break; Break

  IT WAS REPORTED THAT DURING THE PROCEDURE THE TIP OF THE IMPLANTING DEVICE DETACHED WHILE IN USE BY THE SURGEON. A FLUOROSCOPY WAS DONE THAN THEY LOCATED AND REMOVED THE DEVICE SINCE IT WAS IN THE PATIENT. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16390267 ↗
• InjuryNov 17, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT MANUFACTURER REPRESENTATIVE (REP) REP INDICATED THE DUAL CARRIER DIDN'T HAVE THE SECOND CARRIER PORT CUT OUT TO ALLOW THE SECOND EXTENSION TO BE ATTACHED. HCP ENDED UP USING IT SINGLE PORT CARRIER AND DID IT TWICE. NO ISSUE WITH IMPEDANCE AFTER TESTING. REP SAID SHE DOESN'T HAVE THE CARRIER TO SEND BACK, HOWEVER SHE TOOK A VIDEO OF IT. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15814864 ↗
• MalfunctionSep 13, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP) WHO REPORTED AT A CASE TODAY THEY OPENED A TUNNELING CARRIER AND IT APPEARED TO BE ¿PARTIALLY COMPLETED.¿ ACCORDING TO THE REP IT ¿LOOKED LIKE THERE WAS A HOLE DRILLED FOR THE WIRE, BUT NOWHERE TO INSERT THE HEAD OF THE EXTENSION.¿ THE REP OPENED A SECOND PRODUCT AND COMPLETED THE CASE WITH NO ISSUE. THE TUNNELER KIT WAS RETURNED DUE TO BEING DEFECTIVE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12464834 ↗