CLASS II Device recall · Reported 19 Jul 2017 · FDA Enforcement Report
Infinity 5, Implantable Pulse Generator recalled by St. Jude Medical
St. Jude Medical is recalling Infinity 5, Implantable Pulse Generator, distributed nationwide in the US. The recall was initiated on 2 Jun 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2694-2017
- FDA event ID
- 77509
- Recalling firm
- St. Jude Medical, Plano, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Jun 2017
- FDA classified
- 7 Jul 2017
- Reported
- 19 Jul 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 2 Jun 2017 | Recall initiated by company | |
| 7 Jul 2017 | Classified by FDA | +35 days |
| 19 Jul 2017 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Infinity 5, Implantable Pulse Generator, REF 6661, 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.
Where it was distributed
US Nationwide Distribution
Questions about this recall
Why was it 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.
Which lots are affected?
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
Where was it sold?
US Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 77509This product is part of a recall event; the main page for the event is Infinity 7, Implantable Pulse Generator recalled by St. Jude Medical.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Infinity 7, Implantable Pulse Generator recalled by St. Jude Medical | St. Jude Medical | Packaging Defects | Nationwide | |
| CLASS II | Infinity 5, Implantable Pulse Generator recalled by St. Jude Medical | St. Jude Medical | Packaging Defects | Nationwide | |
| CLASS II | Infinity 7, Implantable Pulse Generator recalled by St. Jude Medical | St. Jude Medical | Packaging Defects | Nationwide |
More recalls from St. Jude Medical
All 47| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | CardioMEMS Heart Failure (HF) System that consist recalled | St. Jude Medical | Device Malfunction | Nationwide |
| Device | CLASS II | Cardiomems HF Pressure Measurement System CardioMEMSTM HF recalled | St. Jude Medical | Labeling Errors | Nationwide |
| Device | CLASS II | Cardiomems HF Pressure Measurement System CardioMEMSTM HF recalled | St. Jude Medical | Labeling Errors | Nationwide |
| Device | CLASS II | Merlin.net Patient Care Network recalled by St. Jude Medical | St. Jude Medical | Device Malfunction | 13 states |
| Device | CLASS II | Agilis NxT Steerable Introducer recalled by St. Jude Medical | St. Jude Medical | Other | MN |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |