Product Liability Archives | TorHoerman Law

Question 1

What Abbott spinal cord stimulator models may be involved in lawsuits?

Accepted Answer

The Abbott models most likely to be relevant on this page are the Proclaim family, including Proclaim, Proclaim XR, and Proclaim Plus, along with the newer Eterna system.

FDA materials describing Abbott’s spinal cord stimulation systems identify Proclaim Plus, Proclaim XR, and Eterna as part of Abbott’s approved SCS platform, and earlier FDA materials also identify Proclaim and Proclaim XR systems.

Eligibility in a lawsuit does not turn on the brand name alone.

It usually depends on the exact implanted device, the component involved, the timing of the symptoms, and what the operative records, implant card, and follow-up medical records show.

Question 2

Has Abbott recalled any spinal cord stimulator devices?

Accepted Answer

Yes. Abbott spinal cord stimulator devices have been the subject of several FDA recall actions, but the details matter.

In 2023, the FDA classified a Class I recall affecting multiple Abbott implantable pulse generators, including certain Proclaim Plus 7, Proclaim XR 5, Proclaim XR 7, Proclaim DRG, Infinity 5, and Infinity 7 devices.

The stated reason was that some patients could be unable to exit MRI mode if the patient controller lost communication with the implanted device, which could interrupt therapy delivery.

In 2024, the FDA also posted Class II recalls involving several Abbott implantable pulse generators, not just Proclaim XR 5 and Proclaim 5.

Those recalls included additional Proclaim, Proclaim Plus, and related models.

The stated issue was that the time between the elective replacement indicator and end of service could be shorter than the product labeling described.

More recently, FDA recall records for Abbott’s PMA line also show a Class II recall posted November 7, 2025 for the Eterna SCS implantable pulse generator, model 32400.

FDA records identify that recall in the Abbott spinal cord stimulation recall history, which makes Eterna relevant to any current review of Abbott device safety actions.

A recall does not automatically create a legal claim.

Its significance depends on the exact device implanted, the recall issue involved, the patient’s symptoms, and whether the medical records connect the recall-related problem to later treatment or injury.

Question 3

What problems have people reported with Abbott spinal cord stimulators?

Accepted Answer

Lawsuit reporting and FDA materials reflect several recurring problem themes involving Abbott spinal cord stimulators.

These include allegations of lead migration, device malfunction, loss of pain relief, communication problems, MRI-mode issues, painful or unintended stimulation, and complications that allegedly led to revision or explant surgery.

Some FDA adverse event reports also describe inadequate pain relief, wireless communication problems, and failure of implant events.

Those reports do not prove that a device defect caused a patient’s injury, but they help show the kinds of problems that have been publicly reported in connection with these systems.

Question 4

Can I file a lawsuit if my Abbott stimulator was removed or revised?

Accepted Answer

Possibly, yes.

Revision or explant surgery may strongly support a potential claim because it can help document that the patient experienced a significant device-related problem serious enough to require additional treatment.

That does not automatically mean a lawsuit will succeed.

The claim still depends on the surrounding facts, including whether the records show malfunction, migration, failed therapy, painful stimulation, infection, or another serious complication tied to the implanted Abbott system.

In practice, the most important materials are usually the operative reports, implant records, imaging, programming history, and revision or removal records.

Those documents help show what device was implanted, what went wrong, and what treatment was required afterward.

Question 5

Does an Abbott recall automatically mean I have a lawsuit?

Accepted Answer

No.

A recall does not automatically create a legal claim, and it does not by itself establish that Abbott is legally liable in any individual case.

A recall may still become important evidence when it is combined with proof that the patient received the recalled or affected device, experienced a malfunction or injury, and required additional medical treatment.

In other words, the recall can be relevant, but the strength of the case still depends on the patient’s implant records, symptoms, medical care, and the connection between the device issue and the harm claimed.

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