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Infinity recallZ-2510-2023 · Abbott Medical · initiated Jul 18, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Abbott Medical or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators).

FDA root cause category: Under Investigation by firm

What the company is doing

On 07/20/2023, the firm will send an "URGENT MEDICAL DEVICE CORRECTION" Letter via mail with delivery tracking to customers informing them, Abbott has received complaints from patients who are unable to exit MRI mode, as their Patient Controller has lost the ability to connect or communicate with their IPG while in MRI mode. Situations where this has occurred include where the user deleted the Bluetooth pairing, lost or disabled their Patient Controller, or upgraded the iOS! software on their Patient Controller while in MRI mode. Next Steps for Customers: Per Abbott's Instructions for Use, patients are advised to contact their physician before having an MRI to discuss all critical information regarding MRI scans and MRI mode. In alignment with the Clinician Programmer and Patient Controller Instructions for Use, Abbott recommends physicians do the following: " For the Patient Controller, advise the patient not to delete the paired Bluetooth connection between their IPG and the Patient Controller and not to alter, damage or lose their Patient Controller while the IPG is in MRI mode. " For the Patient Controller prior to entering MRI mode, ensure patients have upgraded their Patient Controller to the latest "Patient Controller NR - US" application from the Apple! App Store!. This version of the application provides instructions for the user not to delete the IPG pairing while the system is in MRI mode. " For the Clinician Programmer, maintain the paired Bluetooth connection between the IPG and the Clinician Programmer by avoiding deleting the pairing and disabling automatic iOS! software upgrades from the iOS! settings. " For questions about this issue or to report patients who are unable to exit MRI mode, please contact your local Abbott representative or Abbott Technical Support at 1-800-727-7846 (option 3) for assistance.

Recall details

Recall number
Z-2510-2023
Status
Open, Classified
Initiated by the company
Jul 18, 2023
Posted by the FDA
Sep 11, 2023
Recalling firm
Abbott Medical
Quantity
5,932 devices (US-4,464; OUS-1,468)
Product code
LGW
FDA submissions
P010032, P010032S096, P010032S151
Distribution
Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Costa Rica, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Germany, Greece, Hungary, India, Iraq, Ireland, Israel, Italy, Japan, Korean, Kuwait, Lithuania, Luxembourg, Mexico, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Reunion, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom.

Product description

Infinity 5 Implantable Pulse Generator REF 6660 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensions or leads with up to 16 electrodes total. It is powered by a hermetically sealed battery within a titanium case and uses microelectronic circuitry to generate constant-current electrical stimulation. The IPG can deliver stimulation with a single program or with multiple programs. Each program can provide stimulation to a single anatomical area or to multiple areas. The IPG communicates wirelessly with system programmers and controllers, and the IPGs are available in small and large sizes to accommodate different power needs. The Proclaim" XR and Proclaim" Plus IPGs are used for Spinal Cord Stimulation (SCS). The Proclaim" DRG IPG is used for Dorsal Root Ganglion (DRG) stimulation. The Infinity" IPG is used for Deep Brain Stimulation (DBS).

Code information (models, lots, serial numbers)

Show the full code information (53k characters)

Model Number: 6660 UDI-DI Codes: 05415067030016 Serial Numbers: US AAD255.1 AAN997.1 AAP328.1 AAT540.1 AAT579.1 AAT652.1 AAT772.1 AAT783.1 AAT795.1 AAT797.1 AAT845.1 AAT902.1 AAT989.1 AAU009.1 AAU022.1 AAU046.1 AAU078.1 AAU094.1 ABM541.1 ABM592.1 ABM630.1 ABT798.1 ABT829.1 ABT841.1 ABT900.1 ACD800.1 ACE689.1 ACE771.1 ACE786.1 ACE838.1 ACE875.1 ACE936.1 ACE939.1 ACE994.1 ACF048.1 ACK145.1 ACK161.1 ACK241.1 ACK511.1 ACK514.1 ACK549.1 ACK622.1 ACK629.1 ACK637.1 ACK699.1 ACK702.1 ACK739.1 ACK752.1 ACK803.1 ACK805.1 ACK806.1 ACK828.1 ACK855.1 ACP686.1 ACP700.1 ACP712.1 ACP770.1 ACP780.1 ACP835.1 ACP869.1 ACP881.1 ACP883.1 ACT538.1 ACT548.1 ACT565.1 ACT738.1 ACU349.1 ACU381.1 ACU424.1 ADR673.1 ADR679.1 ADR685.1 ADR787.1 ADR794.1 ADR852.1 ADR856.1 ADW762.1 ADW766.1 ADW771.1 AEH704.1 AEH745.1 AEH748.1 AEH761.1 AEH764.1 AEH772.1 AEH826.1 AEH831.1 AEH856.1 AEH862.1 AEH865.1 AEH877.1 AEH883.1 AEH953.1 AEH955.1 AEH962.1 AEH972.1 AEJ054.1 AEJ100.1 AEJ101.1 AEJ111.1 AEJ145.1 AEJ164.1 AEJ167.1 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BTX055.1 BTX255.1 BTX340.1 BTX391.1 BTX771.1 BTX862.1 BTX866.1 BUA542.1 BUA678.1 BUA717.1 BUA722.1 BUA781.1 BUA911.1 BUA949.1 BUB189.1 BUB821.1 BUF276.1 BUF284.1 BUF355.1 BUF420.1 BUF470.1 BUF574.1 BUF615.1 BUF655.1 BUJ872.1 BUJ924.1 BUJ936.1 BUJ942.1 BUK116.1 BUK709.1 BUL536.1 BUL624.1 BUP193.1 BUP222.1 BUP228.1 BUP309.1 BUP339.1 BUP422.1 BUP452.1 BUP468.1 BUP469.1 BUP511.1 BUP722.1 BUP766.1 BUP768.1 BUP782.1 BUR846.1 BUR930.1 BUR998.1 BUS003.1 BUS143.1 BUV018.1 BUV081.1 BUV272.1 BUV301.1 BUV348.1 BUV425.1 BUV474.1 BUV487.1 BUV591.1 BUW586.1 BUW659.1 BUW720.1 BUX369.1 BUX419.1 BUX702.1 BUX704.1 BUY439.1 BUY467.1 BUY521.1 BUY875.1 BUY996.1 BUZ097.1 BVD868.1 BVD934.1 BVD951.1 BVE082.1 BVE234.1 BVE237.1 BVE284.1 BVE301.1 BVE318.1 BVK023.1 BVK063.1 BVL022.1 BVL275.1 BVL521.1 BVL603.1 BVL641.1 BVL688.1 BVL793.1 BVP221.1 BVP364.1 BVP424.1 BVX198.1 BVX240.1 BVX254.1 BVX332.1 BVX361.1 BVX380.1 BVX417.1 BVX549.1 BVX574.1 BVY386.1 BVY451.1 BVY504.1 BVY547.1 BVZ742.1 BVZ796.1 BVZ915.1 BVZ971.1 BWC163.1 BWC166.1 BWC191.1 BWC200.1 BWC211.1 BWC242.1 BWC397.1 BWC511.1 BWC536.1 BWC574.1 BWE867.1 BWE881.1 BWF132.1 BWG067.1 BWG069.1 BWG081.1 BWG141.1 BWG166.1 BWG241.1 BWG283.1 BWG419.1 BWJ619.1 BWJ651.1 BWJ684.1 BWJ743.1 BWK032.1 BWP561.1 BWV536.1 BWV559.1 BWV561.1 BWV660.1 BXB050.1 BXB433.1 BXB473.1 BXB509.1 BXH686.1 BXH843.1 BXH910.1 BXJ839.1 BXK403.1 BXK457.1 BXK475.1 BXK703.1 BXK751.1 BXK822.1 BXK996.1 BXL051.1 BXM527.1 BXM650.1 BXM707.1 BXM724.1 BXM760.1 BXM763.1 BXM782.1 BXM789.1 BXM805.1 BXM935.1 BXM936.1 BXN562.1 BXN762.1 BXN787.1 BXP083.1 BXP088.1 BXR187.1 BXR226.1 BXR228.1 BXT598.1 BXT623.1 BXW379.1 BXW391.1 BXW505.1 BXW533.1 BXW598.1 BXY645.1 BXY746.1 BXY747.1 BYD744.1 BYD754.1 BYD815.1 BYD841.1 BYD869.1 BYD873.1 BYD999.1 BYE036.1 BYE045.1 BYE051.1 BYE096.1 BYE107.1 BYE116.1 BYE205.1 BYE210.1 BYE235.1 BYE484.1 BYG463.1 BYG468.1 BYG480.1 BYG555.1 BYG564.1 BYG710.1 BYG732.1 BYG834.1 BYL777.1 BYL840.1 BYL854.1 BYL913.1 BYL981.1 BYM005.1 BYM042.1 BYM062.1 BYR453.1 BYR496.1 BYR526.1 BYR528.1 BYR573.1 BYU429.1 BYV311.1 CAE026.1 CAE096.1 CAF758.1 CAF975.1 CAG778.1 CAG966.1 CAG982.1 CAH025.1 CAH031.1 CAH867.1 CAH873.1 CAH948.1 CAH984.1 CAJ299.1 CAJ343.1 CAK520.1 CAK648.1 CAK665.1 CAK669.1 CAK697.1 CAK803.1 CAM524.1 CAM539.1 CAN511.1 CAN514.1 CAN564.1 CAS397.1 CAT192.1 CAV718.1 CAV738.1 CAX043.1 CAX105.1 CAX170.1 CAX273.1 CAX460.1 CAY169.1 CAY238.1 CAY243.1 CBA332.1 CBA370.1 CBB249.1 CBB260.1 CBB278.1 CBB304.1 CBB433.1 CBB475.1 CBB500.1 CBC244.1 CBC254.1 CBC259.1 CBC280.1 CBC282.1 CBC290.1 CBC294.1 CBC296.1 CBC391.1 CBC418.1 CBC425.1 CBC448.1 CBC509.1 CBC514.1 CBC520.1 CBC553.1 CBC556.1 CBC557.1 CBC580.1 CBC610.1 CBC611.1 CBC612.1 CBC616.1 CBC624.1 CBF866.1 CBG708.1 CBG712.1 CBH251.1 CBH274.1 CBH353.1 CBH534.1 CBK361.1 CBK419.1 CBK697.1 CBM236.1 CBM368.1 CBM376.1 CBM435.1 CBM447.1 CBM465.1 CBM583.1 CBM588.1 CBM592.1 CBR921.1 CBR930.1 CBS011.1 CBT987.1 CBU093.1 CBU125.1 CBU277.1 CBW105.1 CBW136.1 CBW210.1 CBW212.1 CBW305.1 CBW380.1 CBX069.1 CBX153.1 CBX242.1 CBX249.1 CBY577.1 CBY589.1 CBY632.1 CBY663.1 CBY671.1 CBY672.1 CBY700.1 CBY757.1 CBY790.1 CBY835.1 CBY873.1 CBY876.1 CBY909.1 CBY911.1 CBY936.1 CBZ721.1 CCA103.1 CCA137.1 CCA232.1 CCC628.1 CCC645.1 CCD143.1 CCD246.1 CCD280.1 CCD299.1 CCD316.1 CCD447.1 CCD526.1 CCD578.1 CCD584.1 CCD588.1 CCD592.1 CCF628.1 CCF655.1 CCF679.1 CCF735.1 CCF899.1 CCF923.1 CCG703.1 CCG733.1 CCG743.1 CCG790.1 CCG842.1 CCG917.1 CCG941.1 CCG966.1 CCG995.1 CCH012.1 CCS156.1 CCS255.1 CCS466.1 CCV843.1 CCV987.1 CCW739.1 CCW742.1 CCW820.1 CCX038.1 CCX062.1 CCX084.1 CCX099.1 CCX101.1 CCZ074.1 CDR535.1 CDV128.1 CDV184.1 CDW533.1 CDW598.1 CEB897.1 CEG029.1 CEH452.1 CEK456.1 CEP478.1 CEP512.1 CEP517.1 CEP570.1 CEP573.1 CER406.1 CER502.1 CET330.1 CET789.1 CFE899.1 CFF102.1 CFF171.1 CFL746.1 CFP967.1 CFU275.1 CFU454.1 CFU558.1 CFU599.1 CFU637.1 CFV512.1 CFV536.1 CFV571.1 CFV705.1 CFV795.1 CFV808.1 CFX138.1 CFX140.1 CFX179.1 CFX201.1 CFX214.1 CFX301.1 CFX401.1 CFZ937.1 CGA006.1 CGA019.1 CGA022.1 CGA122.1 CGA227.1 CGA239.1 CGA343.1 CGA530.1 CGA543.1 CGD806.1 CGD820.1 CGG926.1 CGG939.1 CGH092.1 CGH118.1 CGH313.1 CGH430.1 CGH779.1 CGH785.1 CGH811.1 CGH885.1 CGL026.1 CGL064.1 CGL099.1 CGL263.1 CGL298.1 CGL299.1 CGL341.1 CGL365.1 CGL411.1 CGL427.1 CGL729.1 CGL745.1 CGL761.1 CGL762.1 CGL767.1 CGL771.1 CGL773.1 CGL802.1 CGL813.1 CGP070.1 CGP074.1 CGP115.1 CGP183.1 CGP204.1 CGP211.1 CGP262.1 CGP286.1 CGP303.1 CGP448.1 CGS702.1 CGS704.1 CGS744.1 CGS789.1 CGS806.1 CGS813.1 CGS821.1 CGS848.1 CGS850.1 CGU053.1 CGU059.1 CGU085.1 CGU092.1 CGU129.1 CGU142.1 CGU240.1 CGU252.1 CGU297.1 CGU302.1 CGU303.1 CGW270.1 CGY885.1 CHB090.1 CHB130.1 CHB184.1 CHB228.1 CHE807.1 CHE852.1 CHE859.1 CHF028.1 CHF051.1 CHF189.1 CHH652.1 CHH748.1 CHH796.1 CHH798.1 CHH808.1 CHH834.1 CHH845.1 CHH873.1 CHK299.1 CHK381.1 CHK492.1 CHK574.1 CHK579.1 CHK636.1 CHK662.1 CHL944.1 CHL953.1 CHM024.1 CHM052.1 CHM123.1 CHM201.1 CHM235.1 CHM270.1 CHM350.1 CHM402.1 CHM429.1 CHM463.1 CHM495.1 CHM546.1 CHM569.1 CHM591.1 CHP624.1 CHP729.1 CHR146.1 CHR202.1 CHT294.1 CHT322.1 CHT466.1 CHT533.1 CHT534.1 CHT537.1 CHT687.1 CHT833.1 CHV708.1 CHV746.1 CHW477.1 CHW483.1 CHW520.1 CHW558.1 CHZ470.1 YW0022.1 YW0038.1 YW0089.1 YW0185.1 YW0238.1 YW0282.1 YW0387.1 YW0483.1 YX8973.1 YX8974.1 YX9006.1 YX9010.1 YX9012.1 YX9026.1 YX9031.1 YX9048.1 YX9058.1 YX9063.1 YX9149.1 YY3001.1 YY3014.1 YY6058.1 YZ1455.1 YZ1474.1 YZ1543.1 YZ1550.1 YZ1556.1 YZ1613.1 YZ9626.1 YZ9694.1 YZ9704.1 YZ9730.1 YZ9748.1 YZ9758.1 YZ9771.1 YZ9780.1 YZ9817.1 YZ9897.1 YZ9902.1 ZY8841.1 ZY9281.1 ZY9324.1 ZY9483.1

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

110 devices cleared under P010032, P010032S096, P010032S151 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 92688).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page