Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported August 21, 2024
WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset, which may lead to transient …
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Boston Scientific Neuromodulation Corporation recalled WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KI… - a moderate-severity action.
WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KI… was recalled by Boston Scientific Neuromodulation Corporation in August 21, 2024. Reason: Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) may experience routine system check during IP…. Check the official notice for the remedy. Verify recall #Z-2617-2024 with the FDA Devices before acting.
The recall
Boston Scientific Neuromodulation Corporation issued this moderate-severity FDA Devices recall-Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) may experience routine system check during IP….
- Moderate
- severity level
- 78K units
- affected scope
- Class II
- classification
- August 21, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2617-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2617-2024) was formally reported on August 21, 2024, with the manufacturer initiating the action on July 17, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Boston Scientific Neuromodulation Corporation is listed as the recalling firm, operating out of Valencia, CA. Federal records list the affected scope as 77,674.
The documented reason for this recall is: Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset, which may lead to transient loss of stimulation; patients may experi… Distribution data in the federal record shows the product reached: Worldwide Distribution: US (nationwide) including states of: TN, PA, WA, SC, MN, OH, NC, AK, NY, IL, CA, NJ, KY, IA, MO, UT, FL, IN, LA, AL, MS, MD, WI, GA, VA, TX, AZ, KS, OR, CO, CT, ID, AR, OK, MA, MI, ND, NE, SD, WV…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
77,674
Related Recalls
6
3 from same agency
Product description
WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320
Reason for recall
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset, which may lead to transient loss of stimulation; patients may experience undesired sensations when therapy turns off for approx. 10-15 seconds and then back on, which may lead patient to request surgical intervention for replacement or revision.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-2617-2024 |
| Date reported | August 21, 2024 |
| Date initiated | July 17, 2024 |
| Recalling firm | Boston Scientific Neuromodulation Corporation |
| Firm location | Valencia, CA |
| Affected scope | 77,674 |
| Distribution | Worldwide Distribution: US (nationwide) including states of: TN, PA, WA, SC, MN, OH, NC, AK, NY, IL, CA, NJ, KY, IA, MO, UT, FL, IN, LA, AL, MS, MD, WI, GA, VA, TX, AZ, KS, OR, CO, CT, ID, AR, OK, MA, MI, ND, NE, SD, WV, NV, HI, NH, DC, MT… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2617-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-1232, 32 IPG KIT, REF: M365SC12320. Recalled by Boston Scientific Neuromodulation Corporation. Units affected: 77,674.
Why was this product recalled? ▼
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset, which may lead to transient loss of stimulation; patients may experience undesired sensations when therapy turns off for approx. 10-15 seconds and then back on, which may lead patient to request surgical intervention for replacement or revision.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 21, 2024. Severity: Moderate. Recall number: Z-2617-2024.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution: US (nationwide) including states of: TN, PA, WA, SC, MN, OH, NC, AK, NY, IL, CA, NJ, KY, IA, MO, UT, FL, IN, LA, AL, MS, MD, WI, GA, VA, TX, AZ, KS, OR, CO, CT, ID, AR, OK, MA, MI, ND, NE, SD, WV, NV, HI, NH, DC, MT, ME, VT, WY, DE, NM. OUS (foreign) countries of: Canada, Algeria, Austria, Azerbaijan, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Hungary, Ireland, Israel, Italy, Lebanon, Luxembourg, Netherlands, Norway, Poland, Qatar, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Turkey, Ukraine, United Arab Emirates, Portugal, Japan, Australia, New Zealand, Singapore, Argentina, Brazil, Colombia, Puerto Rico.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2617-2024) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 21, 2024. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.