Abbott Medical: Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known as Proclaim" 5 Elite IPG) Model 3660 Product Description: The implantable pulse generator (IPG) is an electronic d

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: 113,784 devices (U.S.-95,226; OUS-18558) Lot/code info: Model Number: 3660 UDI-DI Codes: 05415067031419 05415067020192 Serial Numbers: US AAD154.1 AAD159.1 AAD161.1 AAD172.1 AAD197.1 AAD199.1 AAD200.1 AAD206.1 AAD211.1 AAD214.1 AAD219.1 AAD222.1 AAD230.1 AAD232.1 AAD235.1 AAD240.1 AAD241.1 AAD246.1 AAD248.1 AAD252.1 AAD260.1 AAD268.1 AAD269.1 AAD274.1 AAD282.1 AAD284.1 AAD286.1 AAD291.1 AAD292.1 AAD303.1 AAD304.1 AAD305.1 AAD306.1 AAD311.1 AAD312.1 AAD317.1 AAD321.1 AAD334.1 AAD337.1 AAD341.1 AAD343.1 AAD358.1 AAD361.1 AAD363.1 AAD364.1 AAD366.1 AAD369.1 AAD370.1 AAD374.1 AAD378.1 AAD382.1 AAN928.1 AAN929.1 AAN930.1 AAN931.1 AAN932.1 AAN935.1 AAN937.1 AAN942.1 AAN945.1 AAN949.1 AAN950.1 AAN956.1 AAN961.1 AAN966.1 AAN967.1 AAN972.1 AAN978.1 AAN979.1 AAN983.1 AAN985.1 AAN986.1 AAN992.1 AAN994.1 AAN999.1 AAP002.1 AAP003.1 AAP012.1 AAP021.1 AAP027.1 AAP037.1 AAP039.1 AAP041.1 AAP042.1 AAP051.1 AAP058.1 AAP064.1 AAP065.1 AAP068.1 AAP071.1 AAP073.1 AAP074.1 AAP084.1 AAP086.1 AAP087.1 AAP091.1 AAP098.1 AAP101.1 AAP105.1 AAP110.1 AAP112.1 AAP123.1 AAP128.1 AAP130.1 AAP131.1 AAP136.1 AAP138.1 AAP141.1 AAP142.1 AAP143.1 AAP145.1 AAP151.1 AAP154.1 AAP155.1 AAP156.1 AAP158.1 AAP161.1 AAP163.1 AAP169.1 AAP170.1 AAP171.1 AAP181.1 AAP184.1 AAP204.1 AAP206.1 AAP210.1 AAP222.1 AAP232.1 AAP240.1 AAP241.1 AAP245.1 AAP247.1 AAP248.1 AAP249.1 AAP257.1 AAP258.1 AAP262.1 AAP265.1 AAP272.1 AAP284.1 AAP287.1 AAP296.1 AAP304.1 AAP306.1 AAP309.1 AAP312.1 AAP316.1 AAP317.1 AAP320.1 AAP322.1 AAP323.1 AAP335.1 AAP337.1 AAP340.1 AAP341.1 AAP343.1 AAP344.1 AAP34

UPC codes

05415067031419, 05415067020192

Source

Official record: FDA (Device enforcement) ↗

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