Abbott Medical: Proclaim" XR 7 Implantable Pulse Generator REF 3662 (previously known as Proclaim" 7 Elite IPG) Product Description: The implantable pulse generator (IPG) is an electronic device desig

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: 41,745 devices (US-32,782, OUS-8,963) Lot/code info: Model Number: 3662 UDI-DI Codes: 05415067031426 05415067020222 Serial Numbers: US AAD135.1 AAD136.1 AAD137.1 AAD139.1 AAD141.1 AAD145.1 AAD153.1 AAD158.1 AAD162.1 AAD164.1 AAD165.1 AAD166.1 AAD170.1 AAD171.1 AAD173.1 AAD174.1 AAD176.1 AAD178.1 AAD179.1 AAD181.1 AAD182.1 AAD186.1 AAD191.1 AAD196.1 AAD198.1 AAD205.1 AAD209.1 AAD215.1 AAD217.1 AAD221.1 AAD225.1 AAD226.1 AAD228.1 AAD234.1 AAD236.1 AAD237.1 AAD238.1 AAD242.1 AAD243.1 AAD263.1 AAD265.1 AAD275.1 AAD277.1 AAD278.1 AAD287.1 AAD288.1 AAD289.1 AAD290.1 AAD293.1 AAD296.1 AAD307.1 AAD319.1 AAD324.1 AAD325.1 AAD326.1 AAD331.1 AAD335.1 AAD336.1 AAD338.1 AAD344.1 AAD349.1 AAD351.1 AAD354.1 AAD360.1 AAD362.1 AAD368.1 AAD371.1 AAD375.1 AAD383.1 AAN922.1 AAN926.1 AAN936.1 AAN943.1 AAN944.1 AAN955.1 AAN958.1 AAN960.1 AAN963.1 AAN969.1 AAN973.1 AAN980.1 AAN982.1 AAN984.1 AAN987.1 AAN990.1 AAN991.1 AAN993.1 AAN998.1 AAP004.1 AAP008.1 AAP010.1 AAP011.1 AAP013.1 AAP014.1 AAP018.1 AAP020.1 AAP023.1 AAP024.1 AAP025.1 AAP029.1 AAP032.1 AAP034.1 AAP040.1 AAP044.1 AAP047.1 AAP049.1 AAP053.1 AAP054.1 AAP055.1 AAP056.1 AAP059.1 AAP060.1 AAP062.1 AAP069.1 AAP075.1 AAP079.1 AAP081.1 AAP082.1 AAP083.1 AAP089.1 AAP092.1 AAP093.1 AAP094.1 AAP099.1 AAP100.1 AAP106.1 AAP109.1 AAP113.1 AAP115.1 AAP117.1 AAP118.1 AAP119.1 AAP122.1 AAP124.1 AAP125.1 AAP129.1 AAP133.1 AAP134.1 AAP135.1 AAP139.1 AAP144.1 AAP146.1 AAP148.1 AAP157.1 AAP160.1 AAP162.1 AAP166.1 AAP167.1 AAP168.1 AAP173.1 AAP174.1 AAP176.1 AAP179.1 AAP182.1 AAP185.1 AAP190.1 AAP196.1 AAP19

UPC codes

05415067031426, 05415067020222

Source

Official record: FDA (Device enforcement) ↗

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