Abbott Medical: Proclaim Plus 5 Implantable Pulse Generator REF 3670 Product Description: The implantable pulse generator (IPG) is an electronic device designed to be connected to one or more extensio

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: 2,242 device (US only) Lot/code info: Model Number: 3670 UDI-DI Codes: 05415067046383 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 AAP199.1 AAP202.1 AA

UPC codes

05415067046383

Source

Official record: FDA (Device enforcement) ↗

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