Z-2696-2017Class II

Infinity 7, Implantable Pulse Generator, REF 6663, Rx only, STERILE EO

Name: Z-2696-2017 Infinity 7, Implantable Pulse Generator, REF 6663, Rx only, STERILE EO
Creator: St. Jude Medical, Inc.
Published: 2017-06-02
License: https://open.fda.gov/license/

Abbott Medical / initiated 2017-06-02 / Terminated / root cause: design

FDA source

St. Jude Medical, Inc. began a recall of Infinity 7, Implantable Pulse Generator, REF 6663, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to be connected to one... on 2017-06-02. FDA classified it as Class II and gives the reason as "The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2696-2017
Classification: Class II
Status: Terminated
Initiated: 2017-06-02
Posted: 2017-07-07
Terminated: 2022-08-24
Recalling firm: Abbott Medical
Product: Infinity 7, Implantable Pulse Generator, REF 6663, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to be connected to one or two extensions. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG is conductive on all sides, which allows the IPG case (also called a can) to be used as an anode for monopolar stimulation. The IPG communicates wirelessly with system programmers and controllers, and IPGs are available in small and large sizes to accommodate different power needs.
Product code: MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Reason for recall: The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures.
Root cause tag: design
FDA root cause: Device Design
Action: The notification material is in the form of a Physician Letter and Patient letter which will be delivered to physicians and patients in the US. The physician mailing will be initiated June 2, 2017 for delivery on June 7-9, 2017. The physicians were provided with patient management recommendations, Step for the patient controller updates, and Clinician's Manual Revised Warning. The Patient mailings will begin the week of June 12, 2017 to allow for clinician notification and are expected to be delivered within 3-5 business days. The patient letter informs of them of the potential for the loss of therapy and the steps to receive the software upgrade.
Quantity in commerce: 40 units
Distribution: US Nationwide Distribution
Product codes and lots: AAD257.1 AAD302.1 AAP362.1 AAP375.1 AAP385.1 ALX096.1 ALX257.1 ALX258.1 ALY268.1 ALY409.1 ALY435.1 ALY632.1 ALY640.1 ALY763.1 ALY780.1 ALY788.1 ALZ034.1 ALZ042.1 ANT267.1 ANT731.1 ZV3966.1 ZW0230.1 ZW0376.1 ZW0429.1 ZW0458.1 ZW0498.1 ZW0544.1 ZW0545.1 ZW0567.1 ZW0570.1 ZW0576.1 ZW0590.1 ZX5511.1 ZY9379.1 ZY9394.1 ZY9398.1 ZY9405.1 ZY9413.1 ZY9433.1 ZY9530.1

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2696-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2691-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-19	2017-07-07
Z-2692-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-19	2017-07-07
Z-2693-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-19	2017-07-07
Z-2694-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-19	2017-07-07
Z-2695-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-19	2017-07-07
Z-2696-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-19	2017-07-07

Product code MHY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)