Infinity 7 recall
Infinity 7, Implantable Pulse Generator, REF 6663, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to be…
Why was Infinity 7 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Infinity 7, Implantable Pulse Generator, REF 6663, Rx only, STERILE EO Product Usage: The Infinity IPG is an electronic device designed to be…
- Recalling firm
- St. Jude Medical, Inc.
- Quantity
- 40 units
- Distribution
- US Nationwide Distribution
- Recall date
- July 19, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)