Abbott Medical: 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

Hazard

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

Details from the source

Reason for recall: Firm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators). 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 Quantity: 5,932 devices (US-4,464; OUS-1,468) Lot/code info: 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 AEJ196.1 AEJ203.1 AEJ241.1 AEJ251.1 AEJ252.1 AEJ257.1 AEM803.1 AEM833.1 AEM857.1 AEM877.1 AEM885.1 AEM887.1 AEM888.1 AEM951.1 AEM964.1 AEM967.1 AEM969.1 AEM988.1 AFB225.1 AFB349.1 AFB376.1 AFB425.1 AFB433.1 AFB434.1 AFB436.1 AFB444.1 AFB454.1 AFB495.1 AFB658.1 AFG344.1 AFG422.1 AFG446.1 AFG471.1 AFG496.1 AFG545.1 AFG668.1 AFG672.1 AFG679.1 AFG704.1 AFG724.1 AFG750.1 AFG810.1 AFG815.1 AFG819.1 AFG851.1 AFG852.1 AFG857.1 AFG871.1 AFG947.1 AFG959.1 AFZ148.1 AFZ174.1 AFZ198.1 AFZ211.1 AFZ224.1 AFZ260.1 AF

UPC codes

05415067030016

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.