Recall Z-2358-2024 ยท LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
Abbott Medical
Abbott Proclaim XR 5 Implantable Pulse Generator, REF 3660, Sterile EO, Rx Only
| Date | Jul 16, 2024 (initiated May 16, 2024) |
| Status | Open, Classified |
| Reason | The duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than indicated in product labeling. |
| Root cause | Vendor change control |
| Action | On June 6, 2024, Abbott issued a Urgent Medical Device Correction notification to affected consignees. Abbott asked consignees to take the following actions: 1. This issue will continue to affect your patients for the foreseeable future. Abbott is working on an update to align the product labeling with actual device performance. 2. When an ERI notification appears, see the following considerations to make a determination with your patients on timing of IPG replacement within the customer notification. 3. See the customer notification for recommended strategies for preventing lapse in thera |
| Quantity | 83,511 units |
| Distribution | Worldwide - US Nationwide distribution including in the states of ALABAMA, ALASKA, ARIZONA, ARKANSAS, CALIFORNIA, COLORADO, CONNECTICUT, DELAWARE, DISTRICT OF COLUMBIA, FLORIDA, GEORGIA, GUAM, HAWAII, IDAHO, ILLINOIS, INDIANA, IOWA, KANSAS, KENTUCKY, LOUISIANA,MAINE, MARYLAND, MASSACHUSETTS, MICHIGA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.