Reported Oct 25, 2017 · Terminated

Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable Pulse Generator Models 3660, 3661, 3662,…

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?

Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable Pulse Generator Models 3660, 3661, 3662, 3663, 3665, 3667

Lot codes and dates: Serials implanted prior to September 12, 2017 are considered part of this advisory; Serial Numbers -
3,250 of 3,250 codes
AAD135.1
AAD136.1
AAD137.1
AAD138.1
AAD139.1
AAD140.1
AAD141.1
AAD144.1
AAD145.1
AAD146.1
AAD149.1
AAD152.1
AAD153.1
AAD154.1
AAD155.1
AAD157.1
AAD159.1
AAD161.1
AAD162.1
AAD163.1
AAD164.1
AAD165.1
AAD166.1
AAD170.1
AAD171.1
AAD172.1
AAD176.1
AAD178.1
AAD179.1
AAD181.1
AAD182.1
AAD186.1
AAD189.1
AAD191.1
AAD192.1
AAD195.1
AAD196.1
AAD197.1
AAD198.1
AAD199.1
AAD200.1
AAD205.1
AAD206.1
AAD207.1
AAD209.1
AAD210.1
AAD211.1
AAD212.1
AAD214.1
AAD215.1
AAD217.1
AAD219.1
AAD221.1
AAD222.1
AAD223.1
AAD224.1
AAD225.1
AAD226.1
AAD228.1
AAD229.1
Amount recalled: 28,817 devices

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

Nationwide

Why it was recalled

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.

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

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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