Tendril™ STS (REF 2088TC-100)Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 05414734505031), received between Jul 17, 2018 and Feb 24, 2026 — classified as 14 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 24, 2026Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED AND REPLACED WITH A LEADLESS PACEMAKER ON (B)(6) 2026 DUE TO INFECTION. THE PATIENT CONDITION WAS NOT KNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 24425155 ↗
• InjuryDec 8, 2025Failure to Capture; Use of Device Problem; Device Dislodged or Dislocated; Failure to Capture; Use of Device Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING DEVICE CHECKING FOLLOWING DAY AFTER THE IMPLANT, LOSS OF CAPTURE WAS NOTED ON THE LEFT BUNDLE LEAD. CHEST X-RAY CONFIRMED THE LEAD HAD MICRO-DISLODGED AND HAD LITTLE TO NO SLACK. THE LEFT BUNDLE LEAD WAS EXPLANTED AND WAS REPLACED WITH A NEW LEAD. THE PATIENT'S CONDITION WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23743749 ↗
• MalfunctionAug 21, 2025Over-Sensing; Over-Sensing

  DURING FOLLOW-UP, SENSING NOISE WAS OBSERVED ON THE RIGHT VENTRICULAR (RV) LEAD. NOISE COULD BE REPRODUCED WITH PROVOCATIVE TESTING. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED. THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22869003 ↗
• InjuryDec 4, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE ATRIAL LEAD WAS EXPLANTED AND REPLACED DUE TO AN UNKNOWN REASON. THE CONDITION OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20840189 ↗
• MalfunctionNov 27, 2024Failure to Capture; Under-Sensing; Device Dislodged or Dislocated; Failure to Capture; Under-Sensing; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR A DEVICE CHECK. UPON DEVICE INTERROGATION, IT WAS NOTED THAT THE RIGHT ATRIAL (RA) LEAD FAILED TO CAPTURE AT MAXIMUM OUTPUT AND EXHIBITED UNDERSENSING. THE RA LEAD WAS FOUND TO BE DISLODGED. PROGRAMMING CHANGES WERE MADE; THE RA LEAD WILL CONTINUE TO BE MONITORED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20803091 ↗
• InjuryNov 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RELATED MANUFACTURER REFERENCE NUMBER: 2017865-2024-70541. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH A POCKET INFECTION AND EROSION. THE RIGHT ATRIAL (RA) LEAD AND RIGHT VENTRICULAR (RV) LEAD WERE VISIBLE FROM THE OPENED INCISION SITE OF THE IMPLANTED DEVICE POCKET. THE ENTIRE SYSTEM, INCLUDING THE PACEMAKER, RA LEAD, AND RV LEAD, WAS EXPLANTED. THE PATIENT WAS GIVEN ANTIBIOTICS TO TREAT THE INFECTION. THE PATIENT REMAINED IN STABLE CONDITION.

  Patient problems: Pocket Erosion; Unspecified Infection

  MAUDE report 20742445 ↗
• InjuryMay 13, 2024Loose or Intermittent Connection; Failure to Advance; Device Dislodged or Dislocated; Loose or Intermittent Connection; Failure to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN EXPLANT PROCEDURE. PRIOR TO THE PROCEDURE, IT WAS NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD DISLODGED AND EXHIBITED FAILURE TO ADVANCE GUIDEWIRE AND UNSPECIFIED FITTING ISSUE. THE RV LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN STABLE CONDITION THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19296153 ↗
• MalfunctionMay 3, 2024Break; Retraction Problem; Break; Retraction Problem

  DURING AN ELECTIVE REPLACEMENT PROCEDURE, IT WAS NOT POSSIBLE TO RETRACT THE HELIX ON THE LEFT VENTRICULAR (LV) LEAD. LV HELIX DAMAGE WAS ALLEGED. AS A RESULT, THE LV LEAD WAS EXPLANTED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19237678 ↗
• InjuryApr 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH AN UNSPECIFIED INFECTION AND LEAD VEGETATION. THE PHYSICIAN EXPLANTED THE SYSTEM ¿ PACEMAKER, RIGHT ATRIAL LEAD AND RIGHT VENTRICLE LEAD. THE PATIENT WAS IN STABLE CONDITION,

  Patient problems: Unspecified Infection

  MAUDE report 19199562 ↗
• InjuryApr 13, 2023Failure to Capture; Under-Sensing; Failure to Capture; Under-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED IN-CLINIC FOR A FOLLOW UP. INTERROGATION SHOWED THAT THE PATIENT'S RIGHT ATRIAL (RA) LEAD EXHIBITED FAILURE TO CAPTURE AND UNDERSENSING. THE RA LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE THROUGHOUT THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16740432 ↗
• MalfunctionSep 29, 2022Fitting Problem; Failure to Advance; Fitting Problem; Failure to Advance

  DURING ATTEMPTED IMPLANT, THE GUIDEWIRE COULD NOT BE INSERTED INTO THE BODY OF THE LEFT VENTRICULAR (LV) LEAD. A DIFFERENT LV LEAD WAS SUCCESSFULLY IMPLANTED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE AND THERE WERE NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15505213 ↗
• MalfunctionJul 11, 2022Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW UP WITH LEAD NOISE ON THE RIGHT ATRIAL (RA) LEAD. NO INTERVENTIONS WERE MADE OR REPORTED. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14980860 ↗
• InjuryMar 8, 2022Capturing Problem; Device Dislodged or Dislocated; Capturing Problem; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT PRESENTED IN CLINIC FOR FOLLOW UP. CHEST X-RAYS TAKEN SHOWED THE ATRIAL LEAD HAD DISLODGED. THE ATRIAL LEAD WAS EXPLANTED AND REPLACED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13694609 ↗
• MalfunctionMay 25, 2021Difficult to Fold, Unfold or Collapse; Retraction Problem; Difficult to Fold, Unfold or Collapse; Retraction Problem

  PRIOR TO THE IMPLANT PROCEDURE, IT WAS NOTED THAT THE HELIX OF THE LEFT VENTRICULAR (LV) LEAD WAS NOT EXTENDING AND RETRACTING AS EXPECTED. A NEW LV LEAD WAS USED FOR THE PROCEDURE TO RESOLVE THE EVENT. THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11882217 ↗
• InjuryMay 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A PROCEDURE THE LEAD WAS BEING USED AS A TEMPORARY PACEMAKER. A PERICARDIAL EFFUSION DUE TO A PERFORATION BY THE LEAD WAS OBSERVED. AN ULTRASOUND WAS PERFORMED WHICH CONFIRMED THE PERFORATION. FOLLOWING THE PROCEDURE, THE LEAD WAS EXPLANTED. PERICARDIOCENTESIS WAS PERFORMED TO RELIEVE THE PERICARDIAL EFFUSION. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Cardiac Perforation; Pericardial Effusion

  MAUDE report 11777528 ↗
• MalfunctionJul 16, 2020Failure to Advance; Failure to Advance

  DURING THE IMPLANT PROCEDURE, THE GUIDEWIRE WOULD NOT ADVANCE DOWN THE LUMEN OF THE LEFT VENTRICULAR (LV) LEAD. A NEW LV LEAD WAS USED TO RESOLVE THE EVENT. THE PATIENT WAS STABLE WITH NO CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10285651 ↗
• InjuryApr 15, 2020Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT LEAD NOISE WAS OBSERVED ON THE RIGHT VENTRICULAR LEAD VIA REVIEW OF REMOTE TRANSMISSION. THE RV LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9965241 ↗
• MalfunctionSep 6, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL FOR A DEVICE CHANGE-OUT PROCEDURE. DURING THE PROCEDURE, AFTER CHANGING THE DEVICE, THE PHYSICIAN COMMENTED THAT THE OUTER INSULATION ON THE ATRIAL LEAD APPEARED TO HAVE WEAR. A REPAIR KIT WAS USED. AFTER REPAIR, IMPEDANCE AND THRESHOLD TESTING WAS WITHIN NORMAL RANGE AND CONSISTENT WITH PREVIOUS TESTING. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8971194 ↗
• InjuryAug 13, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT PRESENTED FOR A FOLLOW-UP IN CLINIC. UPON DEVICE INTERROGATION, THE PATIENT'S RIGHT VENTRICULAR LEAD WAS NOTED TO HAVE BEEN DISLODGED. A CHEST X-RAY WAS PERFORMED ON (B)(6) 2019 WHICH CONFIRMED THE DISLODGEMENT. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT'S CONDITION WAS STABLE THROUGHOUT THE EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8891175 ↗
• MalfunctionMay 7, 2019Signal Artifact/Noise; Over-Sensing; Signal Artifact/Noise; Over-Sensing

  IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. REVIEW OF TRANSMISSIONS REVEALED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED NOISE. IT WAS NOTED THAT THE NOISE WAS NOT REPRODUCIBLE IN CLINIC WITH ISOMETRICS. NO DEVICE INTERVENTION WAS REPORTED BUT PROGRAMMING CHANGES WERE DISCUSSED. NO PATIENT SYMPTOMS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8589332 ↗
• InjuryAug 8, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS IMPLANTED AND EXPLANTED THE SAME DAY FOR UNSPECIFIED REASONS. NO PATIENT SYMPTOMS OR ADDITIONAL INFORMATION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7762083 ↗
• InjuryJul 18, 2018Failure to Capture; Failure to Capture

  IT WAS REPORTED THAT WHEN THE PATIENT PRESENTED FOR FOLLOW-UP IN CLINIC, LOSS OF CAPTURE ON RIGHT VENTRICULAR LEAD WAS OBSERVED. THE LEAD WAS RE-POSITIONED SUCCESSFULLY ON (B)(6) 2018. PATIENT¿S CONDITION WAS STABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7701023 ↗
• InjuryJul 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING WOUND CHECK FOLLOW-UP IN CLINIC AROUND TWO WEEKS AFTER SYSTEM IMPLANT, ECCHYMOSIS AND ERYTHEMA WAS OBSERVED. THE INCISION WAS RE-DRESSED. INCISION SITE WAS NOTED TO BE HEALING WELL AT THE FOLLOWING TWO WEEK FOLLOW-UP. A MONTH LATER, THE SYSTEM WAS EXPLANTED DUE TO SYSTEMIC INFECTION. THE SOURCE OF INFECTION WAS UNKNOWN. THE PATIENT WAS DEPENDENT, SO A TEMPORARY RIGHT VENTRICULAR LEAD WAS PLACED UNTIL THE INFECTION IS CLEARED WITH ANTIBIOTICS. PATIENT¿S CONDITION WAS STABLE THROUGHOUT THE EVENT.

  Patient problems: Ecchymosis; Erythema; Unspecified Infection

  MAUDE report 7694837 ↗