Medtronic Recharger Kits, RS6230, RS7230, and RS5220A… recallZ-0372-2025 · Medtronic Neuromodulation · initiated Sep 18, 2024

Why it was recalled

The Wireless Rechargers in the kits may be unable to enter a recharging session upon first use.

FDA root cause category: Under Investigation by firm

What the company is doing

The recalling firm issued letters dated September 2024 on 9/18/2024 via UPS 2-Day Air. The letter explained the issue, product scope, and the customer actions. The actions included: (1) Identify and quarantine all unused affected WR Kits. Attachment A of the letter provides guidance on identifying potentially affected devices; (2) Return all unused affected WR Kits using the instructions in the enclosed customer confirmation form and contact Medtronic Customer Service to obtain a replacement WR Kit; (3) Direct patients who cannot establish a recharge session using their WR to promptly contact Medtronic Customer Service to obtain a replacement WR Kit; (4) Complete the enclosed Customer Confirmation Form; (5) Share this notice with all those who need to be aware of this issue within or outside your organization or to any organization where the potentially affected product has been transferred or distributed and maintain a copy of this notice in your records. Medtronic initiated communication of the potential issue via physical mailing to one (1) customer beginning on 08-July-2025 in the U.S.

Recall details

Recall number

Z-0372-2025

Recall class

Class II

Status

Open, Classified

Initiated by the company

Sep 18, 2024

Posted by the FDA

Nov 13, 2024

Recalling firm

Medtronic Neuromodulation

Quantity

118 wireless rechargers

Product code

LGW

FDA submissions

P840001, P960009, P970004, P080025

Distribution

Worldwide - US Nationwide distribution in the states of AL, AZ, CA, FL, GA, ID, MD, MI, MN, MO, NC, NJ, OH, PA, SC, TX, VA, and WA. The countries of Austria, Belgium, Denmark, Finland, Germany, Ireland, Italy, Japan, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, and United Kingdom.

Product description

Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for rechargeable implantable neurostimulators. The Rechargers are used with Neurostimulator Inceptiv INS Model 977119 and Percept RC INS Model B35300 as part of the Deep Brain Stimulation (DBS) system. WR9220A is used with InterStim Micro, Model 97810, as part of Pelvic Health system

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

• N/A RS7230

  Medtronic, Inc. · Stimulator, spinal-cord, totally implanted for pain relief
  1 recall0 reports
• N/A RS6230

  Medtronic, Inc. · Stimulator, electrical, implanted, for parkinsonian symptoms
  1 recall0 reports

Other devices under the same FDA submission

262 devices cleared under P840001, P960009, P970004, P080025 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

• Intellis™ AdaptiveStim® 97715

  Medtronic, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  2 deaths23,976 reports
• INTERSTIM® 3058

  Medtronic, Inc. · Stimulator, electrical, implantable, for incontinence
  6 deaths23,065 reports
• RestoreSensor™SureScan® 97714

  Medtronic, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  6 deaths17,903 reports
• Intellis™ AdaptiveStim® 97715

  Medtronic, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  11,487 reports
• InterStim™ X 97800

  Medtronic, Inc. · Implanted electrical device intended for treatment of fecal incontinence
  5,930 reports
• RestoreSensor 37714

  Medtronic, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  1 death4,116 reports
• ACTIVA RC 37612

  Medtronic, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
  2,839 reports
• InterStim™ Micro SureScan™ 97810

  Medtronic, Inc. · Stimulator, electrical, implantable, for incontinence
  2,757 reports
• PrimeAdvanced® SureScan® 97702

  Medtronic, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  1 death2,263 reports
• RestoreUltra® SureScan® 97712

  Medtronic, Inc. · STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
  1,887 reports
• Activa® RC 37612

  Medtronic, Inc. · STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
  2 deaths1,849 reports
• InterStim™ X 97800

  Medtronic, Inc. · Stimulator, electrical, implantable, for incontinence
  1,822 reports