SenSight™ B31061Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00763000426576), received between Oct 11, 2022 and May 23, 2023 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (20 reports).

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

20 other recalls cover devices cleared under the same FDA submission (H020007, P960009); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Jan 20, 2023Open, Classified

   Medtronic is requesting return of a small number of units of the SenSight Connector Plug, Model B31061, due to a discrepancy in the Use By Date (UBD) printed on the label.

   Z-0121-2024 · Root cause: Labeling Change Control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 23, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE EXPIRATION DATE OF THE CONNECTOR PLUG WAS INCORRECT (B)(6) 2023. IT WAS BEING QUESTIONED IF THIS WAS AN ERROR WITH THE YEAR. NO TROUBLESHOOTING WAS DONE. NO PATIENT INJURY OR HARM WAS REPORTED. ADDITIONAL INFORMATION RECEIVED ON (B)(6)2023 FROM THE MANUFACTURER¿S REPRESENTATIVE (REP), WHICH WAS CONFIRMED WITH THE HEALTHCARE PROVIDER (HCP), REPORTED THE PLUS WAS NOT GOING TO BE REPLACED AND NO SURGERY WAS PLANNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16988838 ↗
• MalfunctionDec 14, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE MANUFACTURER REPRESENTATIVE (REP) HAD FOUR CONNECTOR PLUGS THAT HAVE THE WRONG EXPIRATION DATE OF 3023 (1000 YEARS IN ADVANCE). THE DEVICE WAS REMOVED FROM THEIR STOCK FOR RETURN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15983474 ↗
• MalfunctionDec 14, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE MANUFACTURER REPRESENTATIVE (REP) HAD FOUR CONNECTOR PLUGS THAT HAVE THE WRONG EXPIRATION DATE OF 3023 (1000 YEARS IN ADVANCE). THE DEVICE WAS REMOVED FROM THEIR STOCK FOR RETURN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15983461 ↗
• MalfunctionDec 14, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE MANUFACTURER REPRESENTATIVE (REP) HAD FOUR CONNECTOR PLUGS THAT HAVE THE WRONG EXPIRATION DATE OF 3023 (1000 YEARS IN ADVANCE). THE DEVICE WAS REMOVED FROM THEIR STOCK FOR RETURN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15983227 ↗
• MalfunctionNov 29, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE CONNECTOR PLUG HAD THE WRONG EXPIRATION DATE OF 3023 (1000 YEARS IN ADVANCE). THE DEVICE WAS REMOVED FROM THEIR STOCK FOR RETURN. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15880067 ↗
• MalfunctionNov 14, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT A CONNECTOR PLUG HAS INCORRECT USE BY DATE ON PACKAGING. PER MANUFACTURER REPRESENTATIVE (REP) THIS DEVICE WAS AT THE ACCOUNT. REP WILL DISCUSS FURTHER WITH HCP AS TO NEXT STEPS. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15788080 ↗
• MalfunctionNov 8, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE EXPIRATION DATE ON THIS IMPLANT IS INCORRECT. IT SAYS 3023-11-03. CONTRIBUTING FACTORS THAT MAY HAVE LED TO THIS EVENT INCLUDE TYPO FROM MANUFACTURING PLANT. THERE WAS NO TROUBLESHOOTING OR INTERVENTIONS TAKEN TO RESOLVE THE ISSUE. THE ISSUE HAS BEEN RESOLVED. THERE WAS NO PATIENT INVOLVED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15755044 ↗
• MalfunctionNov 4, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT PHYSICIAN HAS IMPLANTED PLUG ON THE BOTTOM PORT OF THE STIMULATOR. CALLER REPORTS THE STICKER INSIDE THE BOX SHOWS EXPIRATION DATE: 3023/11/03. IT WAS FROM MANUFACTURER REPRESENTATIVE'S (REP) TRUNK. THERE IS NO KNOWN ISSUE TO THE CONNECTOR PLUG AND EXPECTATION IS THAT IT WILL PERFORM THE SAME AS ONE WITH THE CORRECT DATE. NO SYMPTOMS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15734575 ↗
• MalfunctionNov 4, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE PORT PLUG EXPIRATION DATE WAS WRONG ON THE PACKAGING (3023-11-03).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15727804 ↗
• MalfunctionOct 28, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE EXPIRATION DATE WAS MISLABELED ON THE STICKER OUTSIDE OF THE BOX AS WELL AS ON THE STERILE PACKAGE INSIDE THE BOX. THE EXPIRATION DATE READ 3023-11-03. HOWEVER, THE EXPIRATION DATE SHOWN ON AN INTERNAL SYSTEM WAS 2023-11-03. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15693226 ↗
• MalfunctionOct 27, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP) REPORTED THE ISSUE OCCURRED INTRA-OPERATIVELY. THE REP USED A BACK-UP PRODUCT WITH NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15685516 ↗
• MalfunctionOct 27, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE REP HAS 7 CONNECTOR PLUGS WITH MISLABELED EXPIRATION DATE (DATE OF 3023-11-03) ON THE STICKER OUTSIDE OF THE BOX AS WELL AS ON THE STERILE PACKAGE INSIDE THE BOX. HOWEVER, THE EXPIRATION DATE SHOWN ON AN INTERNAL SYSTEM WAS 2023-11-03. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15681791 ↗
• MalfunctionOct 27, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE REP HAS 7 CONNECTOR PLUGS WITH MISLABELED EXPIRATION DATE (DATE OF 3023-11-03) ON THE STICKER OUTSIDE OF THE BOX AS WELL AS ON THE STERILE PACKAGE INSIDE THE BOX. HOWEVER, THE EXPIRATION DATE SHOWN ON AN INTERNAL SYSTEM WAS 2023-11-03. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15681748 ↗
• MalfunctionOct 27, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE REP HAS 7 CONNECTOR PLUGS WITH MISLABELED EXPIRATION DATE (DATE OF 3023-11-03) ON THE STICKER OUTSIDE OF THE BOX AS WELL AS ON THE STERILE PACKAGE INSIDE THE BOX. HOWEVER, THE EXPIRATION DATE SHOWN ON AN INTERNAL SYSTEM WAS 2023-11-03. THERE WAS NO PATIENT INVOLVEMENT. THIS ISSUE WAS CAPTURED FOR THE 6 OTHER PLUGS IN PES (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15681566 ↗
• MalfunctionOct 27, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE REP HAS 7 CONNECTOR PLUGS WITH MISLABELED EXPIRATION DATE (DATE OF 3023-11-03) ON THE STICKER OUTSIDE OF THE BOX AS WELL AS ON THE STERILE PACKAGE INSIDE THE BOX. HOWEVER, THE EXPIRATION DATE SHOWN ON AN INTERNAL SYSTEM WAS 2023-11-03. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15681554 ↗
• MalfunctionOct 27, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE REP HAS 7 CONNECTOR PLUGS WITH MISLABELED EXPIRATION DATE (DATE OF 3023-11-03) ON THE STICKER OUTSIDE OF THE BOX AS WELL AS ON THE STERILE PACKAGE INSIDE THE BOX. HOWEVER, THE EXPIRATION DATE SHOWN ON AN INTERNAL SYSTEM WAS 2023-11-03. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15681503 ↗
• MalfunctionOct 27, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE REP HAS 7 CONNECTOR PLUGS WITH MISLABELED EXPIRATION DATE (DATE OF 3023-11-03) ON THE STICKER OUTSIDE OF THE BOX AS WELL AS ON THE STERILE PACKAGE INSIDE THE BOX. HOWEVER, THE EXPIRATION DATE SHOWN ON AN INTERNAL SYSTEM WAS 2023-11-03. THERE WAS NO PATIENT INVOLVEMENT.  THIS ISSUE WAS CAPTURED FOR THE 6 OTHER PLUGS IN PES (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15681495 ↗
• MalfunctionOct 27, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE MANUFACTURER REPRESENTATIVE (REP) HAS 7 CONNECTOR PLUGS WITH MISLABELED EXPIRATION DATE (DATE OF 3023-11-03) ON THE STICKER OUTSIDE OF THE BOX , AS WELL AS ON THE STERILE PACKAGE INSIDE THE BOX. HOWEVER, THE EXPIRATION DATE SHOWN ON AN INTERNAL SYSTEM WAS 2023-11-03. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15681115 ↗
• MalfunctionOct 11, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE MANUFACTURER'S REPRESENTATIVE (REP) HAD TWO IMPLANTABLE NEUROSTIMULATOR (INS) PLUGS MODEL WITH THE SAME LOT THAT HAVE EXPIRATION PRINTED AS 3 NOV 3023. THE CALLER REPORTED THAT THE PRODUCT WAS SOLD TO ACCOUNT. THE CALLER WILL RETURN THE PRODUCT TO THE ANALYSIS LAB. TECHNICAL SERVICES TRANSFERRED THE CALLER TO CUSTOMER SERVICE TO GET REPLACEMENT PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER'S REPRESENTATIVE (REP) WHO CLARIFIED THAT THERE WAS NO PATIENT INVOLVED IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15584118 ↗
• MalfunctionOct 11, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE MANUFACTURER'S REPRESENTATIVE (REP) HAD TWO IMPLANTABLE NEUROSTIMULATOR (INS) PLUGS MODEL WITH THE SAME LOT THAT HAVE EXPIRATION PRINTED AS 3 NOV 3023. THE CALLER REPORTED THAT THE PRODUCT WAS SOLD TO ACCOUNT. THE CALLER WILL RETURN THE PRODUCT TO THE ANALYSIS LAB. TECHNICAL SERVICES TRANSFERRED THE CALLER TO CUSTOMER SERVICE TO GET REPLACEMENT PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER'S REPRESENTATIVE (REP) WHO CLARIFIED THAT THERE WAS NO PATIENT INVOLVED IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15584116 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under H020007, P960009. One submission often covers many models, so check the product and lot details in each record.

• Z-2240-2026 · May 13, 2026 · Open, Classified
  Medtronic 1x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64001; Stimulator, electrical, implanted, for parkinsonian tremor
• Z-2241-2026 · May 13, 2026 · Open, Classified
  Medtronic 2x4 Pocket Adaptor Kit for Deep Brain Stimulation, Model 64002; Stimulator, electrical, implanted, for parkinsonian tremor
• Z-0206-2025 · Sep 24, 2024 · Open, Classified
  Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.
• Z-0372-2025 · Sep 18, 2024 · Open, Classified
  Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for rechargeable implantable neurostimulators. The Rechargers are used wi
• Z-0217-2024 · May 27, 2022 · Completed
  LEAD 3387S-40 STIMLOC DBS, Model Number 3387S-40. Electrical implantable device.
• Z-1128-2022 · Mar 30, 2022 · Open, Classified
  Percept BrainSense Implantable Neurostimulator (INS), Model B35200
• Z-0418-2022 · Oct 19, 2021 · Open, Classified
  Model B35200 - Percept PC BrainSense Implantable Neurostimulator
• Z-0201-2022 · Sep 23, 2021 · Open, Classified
  Clinician Programmer Application (CPA) model A610 Clinician Software Application
• Z-1368-2021 · Mar 9, 2021 · Open, Classified
  A610 Clinician Programmer Application for Deep Brain Stimulation Clinician Programming Guide Percept PC Model B35200 Neurostimulator Application, version 2.0.4584, 2.0.4594, 2.0.46
• Z-3069-2017 · Mar 17, 2017 · Terminated
  DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead kits, models 3387/3387S, 3389/3389S, and 3391/3391S, The lead kit contains one DBS lead in addition to
• Z-2645-2016 · Jun 23, 2016 · Terminated
  DBS Pocket Adaptor, Model 64001 and Model 64002. The Medtronic Models 64001 (1x4) and 64002 (2x4) Pocket Adaptors can be used as a part of a neurostimulation system for deep brain
• Z-2602-2016 · Jun 10, 2016 · Terminated
  Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).
• Z-1617-2015 · Apr 16, 2015 · Terminated
  Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile
• Z-0279-2014 · Sep 30, 2013 · Terminated
  Medtronic Activa PC, model 37601, and Activa RC, model 37612, Activa SC, models 37602 and 37603. Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation.
• Z-1190-2013 · Feb 8, 2013 · Terminated
  Medtronic DBS Lead Kit for Deep Brain Stimulation, models 3387, 3387S, 3389, 3389S, 3391, 3391S. Sterile and Non-Pyrogenic. Product Usage: The deep brain stimulation system del

…and 5 more.