Back to search
FDAFDA · Food and drugs·Recall number Z-0023-2018

Infinity 5 Implantable Pulse Generator and Infinity 7 Implantable Pulse Generator Models 6660, 6661, 6662, 6663

Published October 25, 2017 · Recall initiated: September 12, 2017

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
St. Jude Medical, Inc.
Distributor
Worldwide Distribution - US (nationwide) (foreign consignee list will be provide by the firm at a later time)
Lot
Serials implanted prior to September 12, 2017 are considered part of this advisory; Serial Numbers - AAD193.1 AAD194.1 AAD213.1 AAD255.1 AAD257.1 AAD261.1 AAD276.1 AAD279.1 AAD281.1 AAD298.1 AAD299.1 AAD302.1 AAD309.1 AAD328.1 AAD372.1 AAD376.1 AAD380.1 AAN940.1 AAN946.1 AAN951.1 AAN977.1 AAN997.1 AAP006.1 AAP007.1 AAP030.1 AAP035.1 AAP108.1 AAP132.1 AAP140.1 AAP149.1 AAP193.1 AAP217.1 AAP266.1 AAP273.1 AAP279.1 AAP293.1 AAP314.1 AAP328.1 AAP333.1 AAP362.1 AAP363.1 AAP375.1 AAP376.1 AAP385.1 AAP387.1 AAP409.1 AAP410.1 AAT509.1 AAT540.1 AAT571.1 AAT572.1 AAT577.1 AAT579.1 AAT582.1 AAT626.1 AAT634.1 AAT652.1 AAT657.1 AAT660.1 AAT722.1 AAT754.1 AAT772.1 AAT774.1 AAT776.1 AAT783.1 AAT792.1 AAT795.1 AAT797.1 AAT804.1 AAT805.1 AAT830.1 AAT841.1 AAT845.1 AAT849.1 AAT870.1 AAT873.1 AAT885.1 AAT890.1 AAT891.1 AAT899.1 AAT902.1 AAT910.1 AAT976.1 AAT987.1 AAT989.1 AAT990.1 AAT994.1 AAU003.1 AAU009.1 AAU022.1 AAU029.1 AAU031.1 AAU046.1 AAU047.1 AAU056.1 AAU068.1 AAU071.1 AAU084.1 AAU094.1 AAU095.1 AAU096.1 AAU148.1 ABA946.1 ABA964.1 ABA995.1 ABB011.1 ABB022.1 ABB051.1 ABB128.1 ABJ141.1 ABJ142.1 ABJ148.1 ABJ155.1 ABJ156.1 ABJ165.1 ABJ175.1 ABJ177.1 ABJ186.1 ABJ196.1 ABJ197.1 ABJ234.1 ABJ242.1 ABJ243.1 ABJ255.1 ABJ282.1 ABJ284.1 ABJ285.1 ABJ295.1 ABJ311.1 ABJ313.1 ABJ315.1 ABJ321.1 ABJ328.1 ABJ349.1 ABJ386.1 ABJ388.1 ABJ390.1 ABJ392.1 ABJ411.1 ABJ444.1 ABJ445.1 ABJ448.1 ABJ449.1 ABJ458.1 ABJ472.1 ABJ485.1 ABJ501.1 ABJ503.1 ABJ504.1 ABJ505.1 ABJ506.1 ABJ526.1 ABJ556.1 ABJ614.1 ABM287.1 ABM308.1 ABM310.1 ABM312.1 ABM313.1 ABM329.1 ABM334.1 ABM381.1 ABM408.1 ABM459.1 ABM471.1 ABM472.1 ABM540.1 ABM541.1 ABM581.1 ABM589.1 ABM592.1 ABM593.1 ABM620.1 ABM630.1 ABM651.1 ABT714.1 ABT728.1 ABT739.1 ABT740.1 ABT745.1 ABT785.1 ABT798.1 ABT800.1 ABT811.1 ABT829.1 ABT832.1 ABT839.1 ABT841.1 ABT844.1 ABT883.1 ABT892.1 ABT900.1 ABT948.1 ABT956.1 ABT967.1 ABT975.1 ABT981.1 ABT984.1 ABT990.1 ABT991.1 ABU014.1 ABU018.1 ABU024.1 ABU036.1 ABU058.1 ABU061.1 ABU079.1 ABU099.1 ABU107.1 ABU119.1 ABU146.1 ABU164.1 ABU183.1 ACD615.1 ACD617.1 ACD652.1 ACD655.1 ACD656.1 ACD682.1 ACD686.1 ACD721.1 ACD768.1 ACD772.1 ACD773.1 ACD797.1 ACD800.1 ACD802.1 ACD812.1 ACD849.1 ACE661.1 ACE669.1 ACE689.1 ACE699.1 ACE740.1 ACE771.1 ACE772.1 ACE780.1 ACE786.1 ACE838.1 ACE843.1 ACE860.1 ACE868.1 ACE875.1 ACE877.1 ACE892.1 ACE900.1 ACE912.1 ACE917.1 ACE922.1 ACE936.1 ACE939.1 ACE942.1 ACE947.1 ACE994.1 ACF006.1 ACF039.1 ACF048.1 ACF065.1 ACK135.1 ACK136.1 ACK140.1 ACK145.1 ACK159.1 ACK161.1 ACK165.1 ACK200.1 ACK224.1 ACK228.1 ACK231.1 ACK241.1 ACK253.1 ACK269.1 ACK286.1 ACK289.1 ACK318.1 ACK325.1 ACK379.1 ACK385.1 ACK424.1 ACK428.1 ACK429.1 ACK431.1 ACK448.1 ACK457.1 ACK500.1 ACK511.1 ACK514.1 ACK525.1 ACK526.1 ACK549.1 ACK554.1 ACK559.1 ACK581.1 ACK583.1 ACK592.1 ACK594.1 ACK602.1 ACK615.1 ACK622.1 ACK629.1 ACK632.1 ACK634.1 ACK637.1 ACK674.1 ACK677.1 ACK699.1 ACK702.1 ACK705.1 ACK706.1 ACK709.1 ACK719.1 ACK739.1 ACK742.1 ACK744.1 ACK752.1 ACK757.1 ACK759.1 ACK760.1 ACK762.1 ACK775.1 ACK776.1 ACK778.1 ACK783.1 ACK784.1 ACK786.1 ACK803.1 ACK805.1 ACK806.1 ACK828.1 ACK837.1 ACK841.1 ACK844.1 ACK846.1 ACK855.1 ACK872.1 ACP669.1 ACP670.1 ACP675.1 ACP676.1 ACP680.1 ACP684.1 ACP685.1 ACP686.1 ACP687.1 ACP690.1 ACP695.1 ACP700.1 ACP737.1 ACP756.1 ACP767.1 ACP769.1 ACP770.1 ACP775.1 ACP777.1 ACP780.1 ACP783.1 ACP797.1 ACP804.1 ACP820.1 ACP824.1 ACP827.1 ACP829.1 ACP833.1 ACP835.1 ACP836.1 ACP862.1 ACP866.1 ACP869.1 ACP872.1 ACP874.1 ACP881.1 ACP883.1 ACP885.1 ACP890.1 ACP893.1 ACP909.1 ACP915.1 ACT538.1 ACT542.1 ACT547.1 ACT548.1 ACT555.1 ACT556.1 ACT558.1 ACT562.1 ACT563.1 ACT565.1 ACT580.1 ACT582.1 ACT589.
Risk classification
Class II
Area (FDA)
device
Country
United States

Sell products like this?

Recalert watches your whole catalog for recalls like this one, automatically.

Start free — no card