Reported Jul 19, 2017 · Terminated

Infinity 5, Implantable Pulse Generator, REF 6661, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic…

St. Jude Medical, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: St. Jude Medical, Inc. · 6901 Preston Rd · Plano, TX · 75024-2508

Is this the product you have?

Infinity 5, Implantable Pulse Generator, REF 6661, Rx only
STERILE EO Product UsageThe 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

Lot codes and dates: ALX120.1
ALX227.1
ALY287.1
ALY390.1
ALY471.1
ALY534.1
ALY560.1
ALY668.1
ALZ030.1
AMN762.1
AMN904.1
AMN990.1
AMP134.1
AMP169.1
AMP189.1
AMP246.1
AMS702.1
AMT135.1
AMT160.1
AMT357.1
ANG915.1
ANG951.1
ZA3446.1
ZA3511.1
ZB0872.1
ZB1144.1
ZB1181.1
ZB1188.1
ZB1190.1
ZB1200.1
ZB1213.1
ZB1218.1
ZB1225.1
ZB1422.1
ZB1463.1
ZB1507.1
ZK3289.1
ZS0594.1
ZS0699.1
ZS0772.1
ZW0246.1
ZW0268.1
ZW0273.1
ZW0283.1
ZW0364.1
ZW8776.1
ZW8796.1
ZW8863.1
ZW8879.1
ZW8887.1
ZW8904.1
ZW8965.1
ZW8972.1
ZX5593.1
Amount recalled: 54 units

This recall covers 6 products

The agency filed one notice per product. You are reading one of them; the other 5 are below.

Where it was sold

Nationwide

Why it was recalled

The firm discovered a risk of loss of Neuromodulation therapy due to exposure of the IPG to monopolar electrosurgical devices (ESU) during medical procedures.

This product could cause temporary or reversible health problems — stop using it.

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