Lead Adaptor BIS/BIS-40Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00885672008369), received between Jun 5, 2018 and Nov 21, 2025 — classified as 8 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Ambient Noise Problem” (6 reports).

1 other recall cover devices cleared under the same FDA submission (K010787); 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.

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.

• MalfunctionNov 21, 2025Ambient Noise Problem; Device Sensing Problem; Ambient Noise Problem; Device Sensing Problem

  PER CUSTOMER, WE RECEIVED THE FOLLOWING INFORMATION AND PORTIONS OF MYOPORE BP35, MODEL 360882 AND OSCOR IS-1 ADAPTOR (B)(6) (SERIAL NUMBER PORTION RECEIVED). EVENT OCCURRED IN US. NO PATIENT DEATH, HARM, OR INJURY WAS REPORTED. ON (B)(6) 2025 THE PATIENT'S DUAL CHAMBER PACEMAKER WAS EXPLANTED AND UPGRADED TO A CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER. THE CHRONIC MYOPORE RIGHT VENTRICULAR LEAD WOULD HAVE BEEN REUSED BUT WAS BEING EXPLANTED DUE TO NOISE AND SENSING ISSUES. DURING THE PROCEDURE, THE OSCOR IS-1 ADAPTOR WAS SEEN ON FLUOROSCOPY AND WAS ALSO REMOVED, IT IS UNKNOWN IF IT PLAYED A PART IN THE REPORTED ISSUES. THE CHRONIC MYOPORE RIGHT VENTRICULAR LEAD, AND OSCOR ADAPTOR, WERE SUCCESSFULLY EXPLANTED AT CLEVELAND CLINIC MAIN CAMPUS. DURING SAME PROCEDURE, A NEW MEDTRONIC EPICARDIAL RIGHT VENTRICULAR LEAD WAS SUCCESSFULLY IMPLANTED. WE HAVE NO PICTURES, IMAGES, OR VIDEOS TO SHARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23622610 ↗
• MalfunctionJun 28, 2023High impedance; High Capture Threshold; High impedance; High Capture Threshold

  IT WAS REPORTED THE PATIENT WAS SCHEDULED FOR A PACEMAKER RELOCATION PROCEDURE ON (B)(6) 2023. TWO EXTENDERS WERE USED AND TUNNELED THE ABDOMEN. AT THE END OF PROCEDURE, MEASURES WERE WITHIN NORMAL LIMITS. RIGHT ATRIAL (RA) LEAD IMPEDANCE THROUGH DEVICE WAS 530-540 OHMS WITH THRESHOLD OF 0.5/0.4. ON THE MORNING OF (B)(6) 2023, THE RA IMPEDANCE WAS 1126 OHMS IN BIPOLAR AND 837 OHMS IN UNIPOLAR. DURING THE REVISION, THE PHYSICIAN RESET THE CONNECTION INVOLVING THE ATRIAL LEAD AND THE EXTENDER IN THE LEFT PECTORAL POCKET. THE IMPLANTABLE PULSE GENERATOR (IPG), RIGHT ATRIAL (RA) LEAD AND EXTENDER REMAIN IN USE. THERE WAS NO PROCEDURE DELAY AND NO PATIENT COMPLICATIONS HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17216229 ↗
• MalfunctionJan 5, 2023Connection Problem; Connection Problem

  IT WAS REPORTED THAT THE LEAD EXTENDER EXHIBITED AN ADAPTOR MALFUNCTION AND WOULD NOT CONNECT TO THE LEAD. THIS RESULTED IN NO SIGNAL WHEN CONNECTED TO THE ANALYZER. THE LEAD EXTENDER 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 16106543 ↗
• InjuryJul 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PATIENT IS AN 84 YEAR OLD, MALE, WITH THE INITIALS OF (B)(6). IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST REPLACEMENT PROCEDURE, THE PATIENT DEVELOPED A SYSTEMIC INFECTION. THE CARDIAC RE-SYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONALLY, IT WAS REPORTED THE PATIENT IS ALIVE WITH FURTHER INJURY, THE MANUFACTURER IS CURRENTLY INVESTIGATING INTO THIS MATTER. NO ADDITIONAL INFORMATION IS AVAILABLE. REFERENCE REPORT # 1035166-2022-00081.

  Patient problems: Unspecified Infection

  MAUDE report 14946471 ↗
• InjuryJul 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PATIENT IS AN 84 YEAR OLD, MALE, WITH THE INITIALS OF (B)(6). IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST REPLACEMENT PROCEDURE, THE PATIENT DEVELOPED A SYSTEMIC INFECTION. THE CARDIAC RE-SYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ADDITIONALLY, IT WAS REPORTED THE PATIENT IS ALIVE WITH FURTHER INJURY, THE MANUFACTURER IS CURRENTLY INVESTIGATING INTO THIS MATTER. NO ADDITIONAL INFORMATION IS AVAILABLE. REFERENCE REPORT # 1035166-2022-00080.

  Patient problems: Unspecified Infection

  MAUDE report 14946409 ↗
• MalfunctionJun 13, 2022Low impedance; Low impedance

  IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE EXTENDER WAS CONNECTED TO EXISTING LEAD AND THEN CONNECTED TO THE IMPLANTABLE PULSE GENERATOR (IPG) AND LOW IMPEDANCE WAS NOTED 114 OHMS. THE PHYSICIAN PROCEEDED TO TEST THE ORIGINAL LEAD AFTER DISCONNECTING THE EXTENDER AND IT WAS WITHIN NORMAL LIMITS. THE EXTENDER WAS ATTEMPTED IMPLANT, NOT USED AND WAS REPLACED WITH ANOTHER EXTENDER. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14675523 ↗
• InjuryFeb 24, 2021Ambient Noise Problem; Ambient Noise Problem

  IT WAS REPORTED THE LEAD ADAPTOR WAS SUSPECTED TO BE MALFUNCTIONING DUE TO NOISE. THE ADAPTOR WAS EXPLANTED. NO PATIENT COMPLICATION HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11371851 ↗
• InjuryNov 6, 2020High impedance; Over-Sensing; Under-Sensing; Ambient Noise Problem; Noise, Audible; High impedance; Over-Sensing; Under-Sensing; Ambient Noise Problem; Noise, Audible

  IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD AND EXTENDER LEAD EXHIBITED NOISE WITH MOVEMENT, HIGH IMPEDANCE AND UNDERSENSING. BOTH RA LEAD AND EXTENDER LEAD REMAINS IN USE. PATIENT IS A (B)(6) FEMALE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. ON 2020-10-28 IT WAS FURTHER REPORTED THAT THE RA LEAD WAS CAPPED AND REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10800412 ↗
• InjuryJun 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED DUE TO AN INFECTION. THE ORGANISM WAS IDENTIFIED AS STAPHYLOCOCCUS EPIDERMIDIS. A NEW SYSTEM WILL BE IMPLANTED AT A LATER DATE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THERE WAS NO SPECIFIC ISSUE TO THE BIS/ BIS ADAPTOR REPORTED.

  Patient problems: No Consequences Or Impact To Patient; Unspecified Infection

  MAUDE report 10166992 ↗
• MalfunctionMay 6, 2019High impedance; Over-Sensing; Ambient Noise Problem; High impedance; Over-Sensing; Ambient Noise Problem

  AS PER ADDITIONAL INFORMATION REVISION SURGERY WAS SCHEDULE ON 9TH APRIL 2019 BECAUSE OF NOISE AND IMPEDANCE RISE. THERE WAS NO OTHER ISSUE WITH ADAPTOR BIW07451. ADAPTOR REMAINS IN USE. NO FURTHER ISSUES OBSERVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8582370 ↗
• InjuryMay 6, 2019High impedance; Over-Sensing; Ambient Noise Problem; High impedance; Over-Sensing; Ambient Noise Problem

  AS PER ADDITIONAL INFORMATION THERE WAS NO ISSUE WITH ADAPTOR BIW07451. ADAPTOR REMAINS IN USE. FOR ADAPTOR BIW07451 SEE MEDWATCH 1035166-2019-00038.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8582349 ↗
• InjuryFeb 19, 2019Connection Problem; Connection Problem

  IT WAS REPORTED THAT, IMPLANTING PHYSICIAN HAD TO REGAIN AXILLARY VENOUS ACCESS TO PLACE A LEAD 5076-85 ((B)(4)) WHICH WAS THEN TUNNELED TO THE ABDOMEN. PHYSICIAN REMOVED THE ALREADY IMPLANTED 3830-59 BECAUSE OF BOTH ADAPTORS FAILED AND LEAD COULD NOT BE TUNNELED TO THE POCKET AND CONNECTED TO AN ABDOMINAL ICD. THIS 3830 LEAD WAS THEN TO BE EXTENDED AND TUNNELED TO THE ABDOMEN WHERE IT WAS TO BE CONNECTED TO AN ICD. BECAUSE OF THE ADAPTER ISSUE PHYSICIAN CHOOSE TO REMOVE THE 3830 LEAD AND PLACED 5076-85 LEAD AND TUNNEL TO THE ABDOMINAL POCKET. ON BOTH ADAPTOR, THE DISTAL SETSCREW COULD NOT BE ENGAGED WITH A WRENCH KIT TO TIGHTEN THE SCREW. PHYSICIAN HAD TO CUT SILICONE AWAY TO BE ABLE TO ENGAGE THE SCREW. UPON ATTEMPTS TO ENGAGE THE SCREW, THE SCREW WOULD NOT LOCK DOWN ON THE TERMINAL PIN OF THE LEAD - THE SCREW SPUN INCESSANTLY. EVENTUALLY LEADING TO STRIPPING OF THE SCREW. AT A COUPLE MOMENTS THE SCREW JUST FELL OUT OF THE ADAPTOR PORT. RE-ENGAGING THE SCREW WAS CHALLENGING. FIRST ADAPTOR WAS CONNECTED TO THE DEVICE WHERE ELECTRICALLY CHECKED OKAY BUT THEN BECAME VERY NOISY. PHYSICIAN TRY TO ATTEMPT SECOND ADAPTER . THERE WAS NO PATIENT COMPLICATION REPORTED. THERE WAS DELAY IN S

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8351768 ↗
• InjuryJun 28, 2018High impedance; Ambient Noise Problem; High impedance; Ambient Noise Problem

  PATIENT WAS IN FOR AN UPGRADE FROM A DC PACEMAKER TO A BI-V DEVICE. THE OLD SYSTEM WAS ON THE LEFT SIDE, BUT THE VEIN WAS OCCLUDED SO THE IMPLANTER DECIDED TO PUT THE NEW SYSTEM ON THE RIGHT SIDE. HE DECIDED TO KEEP THE OLD RV LEAD AND USE AN OSCOR ADAPTER TO BRING IT OVER TO THE RIGHT. A NEW RA AND LV LEAD WERE IMPLANTED ON THE RIGHT. AFTER THE POCKET WAS CLOSED, THE PATIENT WOKE UP AND MOVED HIS ARMS SUCH THAT THERE SEEMED TO BE SOME DISRUPTION IN THE RV LEAD. LEAD IMPEDANCES CHANGED FROM 551 TO >3000 OHMS. THERE WAS ALSO NOISE ON THE LEAD WITH POCKET MANIPULATION. DOCTOR WENT BACK INTO THE POCKET TO RE-SET THE RV LEAD IN THE ADAPTER. AFTER THEY DID THIS, THE RV IMPEDANCE WAS 720 OHMS AND THE NOISE WAS GONE. HOWEVER, THE DOCTOR AND THE REP WERE UNHAPPY THAT THE IMPEDANCE WAS NOW A LITTLE HIGHER THAN THE INITIAL 550 AND WERE NOT SURE THE ADAPTER WAS OK. THE PATIENT WAS PROGRAMMED TO VOO AND WILL BE KEPT OVERNIGHT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7647813 ↗
• MalfunctionJun 5, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT INTRA-OPERATIVELY, THE LEAD ADAPTOR WAS UNABLE TO BE SECURELY TIGHTENED DOWN WITH THE DEVICE SET SCREW. THE PHYSICIAN ELECTED TO USE A DIFFERENT ADAPTOR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7569946 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K010787. One submission often covers many models, so check the product and lot details in each record.

• Z-2333-2008 · Jan 29, 2008 · Terminated
  Permanent Pacing Lead (Catalog #: 03332, 03334, 03337, 03107, 03116, 03108, 03109, 05756, 53420, 05765, 03634, 03633, and 05747); Model #: PY244RU, PY252RU, PY258RU, REFINO58RU, RE