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.