Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0023-2018 — Infinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse Generator Models 6660, 6661, 6662, 6663

U.S. FDA — Device Enforcement · United States · 2017-09-12 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0023-2018
Date of alert
2017-09-12
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
St. Jude Medical, Inc.
Product category
device
Product type
Devices
Reported risk: Analysis of the difference between the actual device longevity and the battery indicator status provided by the Clinician Programmer (CP) or Patient Controller (PC) has revealed errors in the CP or PC longevity estimations that can overestimate or under estimate the battery indicator status in certain situations.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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