PISCES-QUAD PLUS ™ 3888-45Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169887909), received between Oct 18, 2018 and Oct 12, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Damaged Prior to Receipt by User” (2 reports).

9 other recalls cover devices cleared under the same FDA submission (P840001); 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 12, 2020Break; Material Perforation; Break; Material Perforation

  A MANUFACTURER REPRESENTATIVE REPORTED THAT THE DISTAL PORTION OF THE LEAD COMING OFF WITH THE STYLET LEAVING THE QUAD LEAD EXPOSED WITH NO SHEATH AT THE DISTAL PORTION. THE PHYSICIAN WAS GOING TO REMOVE THE STYLET FROM THE DISTAL PORTION OF THE QUADLEAD AND THE SHEATH THAT PROTECTS THE LEAD CAME OFF THE DISTAL POTION WITH THE STYLET. THE STYLET WAS RE INTRODUCED TO SEE IF IT WAS ABLE TO RESOLVE BY DOING THAT, BUT THE ATTEMPT WAS A FAILURE. ANOTHER QUAD WAS OPENED AND USED TO RESOLVE THE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10662768 ↗
• MalfunctionJan 14, 2019Device Damaged Prior to Receipt by User; Insufficient Device Problem Information; Device Damaged Prior to Receipt by User; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PHYSICIAN WAS IMPLANTING THE LEAD AND WHEN THEY WENT TO REMOVE THE STYLET FROM THE END PORTION OF THE LEAD, THE LEAD CAME OUT COMPLETELY. NO KNOWN FACTORS LED TO THE ISSUE AND THE LEAD WAS NOT USED. THE LEAD CAME OUT FROM THE BOX AND WAS NOT USED. THE LEAD WAS SAID TO BE DEFECTIVE. THE LEAD WAS GOING TO BE RETURNED FOR ANALYSIS. NO SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8243859 ↗
• MalfunctionOct 18, 2018Device Damaged Prior to Receipt by User; Human-Device Interface Problem; Insufficient Device Problem Information; Device Damaged Prior to Receipt by User; Human-Device Interface Problem; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED FROM THE MANUFACTURER'S REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR SPINAL CORD STIMULATION. IT WAS REPORTED THAT THE PHYSICIAN WENT TO IMPLANT LEAD AND ELECTRODE WAS PROTRUDING AND STYLET WAS NOT HOLDING IN PLACE. IT WAS A NEW LEAD STRAIGHT OUT OF THE BOX. LEAD TO BE SENT BACK FOR ANALYSIS. NEW LEAD WAS USED. ISSUE RESOLVED AT THIS TIME. NO FURTHER COMPLICATIONS REPORTED/ANTICIPATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7978888 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P840001. One submission often covers many models, so check the product and lot details in each record.

• 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-1691-2024 · Mar 28, 2024 · Open, Classified
  Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator
• Z-0780-2024 · Dec 19, 2023 · Open, Classified
  Model A710 Intellis Clinician Programmer Application, version 2.0.97
• Z-2159-2021 · Jul 9, 2021 · Open, Classified
  Medtronic Vectris SureScan MRI, Catalog Numbers: a) 977A260 b) 977A275 c) 977A290
• Z-1926-2016 · May 3, 2016 · Terminated
  Medtronic RestoreSensor, Model 37714; and, RestoreSensor SureScan, (MRI), Model 97714, Implantable Neurostimulators. Used to treat chronic, intractable pain of the trunk and/or li
• Z-1147-2015 · Jan 9, 2015 · Terminated
  The Medtronic, Quadripolar ITREL 3 IPG, Model 7425, is a multiprogrammable device designed for use in the Stimulation of the Central Nervous System, Peripheral Nervous System, or m
• Z-1524-2014 · Feb 27, 2014 · Terminated
  Medtronic neurostimulators. Restore (37711), RestoreADVANCED (37713), RestoreADVANCED SureScan MRI (97713), RestoreSENSOR (37714), RestoreSENSOR SureScan MRI (97714), PrimeAdvanced
• Z-0278-2014 · Sep 30, 2013 · Terminated
  Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation.
• Z-1536-06 · Aug 2, 2006 · Terminated
  Medtronic 3777 Lead Kit, 1x8 Low Impedance Lead Kit for Spinal Cord Stimulation (SCS). Manufactured at: Medtronic, Inc., Villalba, Puerto Rico USA. Medtronic, Inc., Minneapolis