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WHAT IS THIS?
A Recall is a firm’s removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action, e.g., seizure. Recall does not include a market withdrawal or a stock recovery.
EVENT
| Type of Event | Recall |
|---|---|
| Recall Numbers | Z-2358-2024, Z-2359-2024, Z-2360-2024, Z-2361-2024, Z-2362-2024, Z-2363-2024, Z-2364-2024, Z-2365-2024, Z-2366-2024, Z-2367-2024, Z-2368-2024, Z-2369-2024 |
| Risk Class | Class 2 |
| Recall Qty | 196,612 Total |
| Classification Date | 2024-07-16 |
| Recall Link | Search FDA Site |
| Notes/Alerts | 12 total recalls for all affected units |
| Recall 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. |
DEVICE
| Manufacturer | Abbott Medical |
|---|---|
| Model Names | Proclaim™ 5, Proclaim™ 5 Elite, Proclaim™ 7, Proclaim™ 7 Elite, Proclaim™ Plus 5, Proclaim™ Plus 7, Proclaim™ XR 5, Proclaim™ XR 7, Proclaim™ DRG |
| Model Numbers | 3660, 3661, 3662, 3663, 3664, 3665, 3667, 3670, 3671, 3672 |
| Part/Item/Catalog/ REF/Product Number | |
| Device Description | Stimulator, spinal-cord, totally implanted for pain relief |
| Serial Number(s) | +196,000. Refer to the specific recall of that Model for details. |
| Lot #/Exp Date(s) | N/A |
CUSTOMER/PATIENT ACTIONS
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 therapy.
4. Please return a completed Acknowledgement Form and maintain a record of this notice along with a copy of the completed Acknowledgement Form.
5. For questions about this issue or reported complaints, please contact your Abbott representative, or Abbott Technical Support at 1-800-727-7846.
6. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
CONTACT INFORMATION
Report any adverse health consequences experienced with the use of this product to GE Healthcare. Events may also be reported to the FDA’s MedWatch Adverse Event Reporting program via:
Web: MedWatch website at www.fda.gov/medwatch
Phone: 1-800-FDA 1088 (1-800-332-1088)
Mail: MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
