Recall Z-2558-2025 ยท NHL Stimulator, Electrical, Implanted, For Parkinsonian Symptoms
Boston Scientific Neuromodulation Corporation
Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
| Date | Sep 12, 2025 (initiated Jul 8, 2025) |
| Status | Open, Classified |
| Reason | Wire break(s) have occurred in rechargeable deep brain stimulation implantable pulse generators, implanted in the submuscular pectoral location. Wire breaks prevent successful stimulation, thus requiring device removal/replacement and users may experience high monopolar impedances, undesired sensation, loss of therapy, return of symptoms and/or Bluetooth connectivity challenges. |
| Root cause | Labeling design |
| Action | On 7/8/2025, correction notices were mailed in the U.S. and mailed, emailed, or hand delivered outside the U.S. Healthcare Professionals were asked to do the following: 1) Review the Surgical Implant Manual updates. 2) If you are a facility that has sent products to another hospital or a facility within your network, ensure this notification is forwarded to them. 3) A patient letter is enclosed with this communication, which can be shared with your patient and/or included within the patient's medical record. 4) Monitor per relevant IFU recommendations for any clinical observations of high mon |
| Quantity | 25,260 |
| Distribution | Worldwide - US Nationwide distribution including in the states of MN, FL, CO, MD, NY, NE, PA, WI, AZ, TN, MO, TX, MI, MT, MA, WV, AL, VA, NC, CA, OR, WA, LA, OH, NJ, NH, SD, GA, CT, NV, UT, IN, ID, IL, ME, SC, DC, OK, KY, AK, HI, RI, AR, KS, NM and the countries of Argentina, Brazil, Chile, Ecuador, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.