Medtronic

All Model 8870 software application cards containing SynchroMed II software are in scope for this action.

General Hospital and Personal Use Devices

3

Yes

Nationwide Distribution

Medtronic, Model 8870, Application Software Card is part of the SynchroMed¿ II Drug Infusion System. The System includes the SynchroMed¿ II implantable drug infusion pump 8637-20, 8637-40, N'Vision clinical programmer 8840 and the Software application card 8870. || The SynchroMed II Infusion system contains and administers prescribed drugs to a specific site inside patient body. The SynchroMed II Pump is supplied in 20 ml and 40 ml reservoir sizes. In the United States, the SynchroMed II Pump is specifically approved for (indicated): ¿ The chronic epidural/intrathecal infusion of Infumorph (preservative-free morphine sulfate sterile solution) in the treatment of chronic intractable pain. ¿ The chronic intrathecal infusion of Lioresal Intrathecal (baclofen injection) in the management of severe spasticity. ¿ The chronic intrathecal infusion of Prialt (preservative-free ziconotide sterile solution) for the management of severe chronic pain. ¿ The chronic intravascular infusion of floxuridine (FUDR) for the treatment of primary or metastatic cancer. ¿ The chronic intravascular infusion of methotrexate for the treatment of primary or metastatic cancer. Outside of the United States, the SynchroMed II Pump is indicated for the chronic infusion of drugs or fluids tested as compatible and listed in the product labeling for the specific geographies.

Serial Numbers: 109R, 118R, 124, 136, 159 ,170, 218, 222, 223, 236, 239 , 299, 309R, 402, 410, 412, 414.

Radiology Devices

2

No

Worldwide Distribution - USA, including the states of AL, CO, FL, IA, MI, IA, NC, NE, NY and the countries of South Africa, Italy, and Spain.

Medtronic O-arm¿ Imaging System. Product Numbers: BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120R, BI-700-00027-230, BI-700-00027-230R.

Spinal implants - locking nuts used in the Medtronic Colorado II spinal implant system. Catalogue number 8634111. Lots: W07G2386, W07G2387, W07G2388, W07G2389, W07G2751, W07H0440, W07H1809 and W07H1810.

Lot number 120203.

Neurological Devices

2

No

Worldwide Distribution--US (nationwide) including the states of CA, FL, MA, LA, and MI and the countries of Switzerland, Saudi Arabia, Lebanon, Canada and Korea.

The Vertex Max Drill Tube is a component within the Navigated Vertex Max Drill Guide Set (item 9733370). The Navigated Vertex Max Drill Guide Set is intended to be used with a Medtronic Computer Assisted Surgery System to help assist with screw placement during spine surgical procedures. The device is reusable and requires sterilization according to product labeling. || .

Pack Model Pack Lot 0E27R16- 11239917  11252800  11264666; 1A30R6- 12132577  12219267; 2493R24- 11187015  11199707  11224309  11227205  11556735; 2493R25- 11646941  11713200  11745242  11813334  11852673  11886412  11990393  12033630  12114699  12178107  12191642  12450856; 5D56R5- 11298229  11357085  11465358  11541270  11601193  11654853  11702415  11745232  11766305  11822320  11838721  11852677  11930380  12024708  12166379  12292156; 5Z93R4- 11713132  11736880  11749958  11766283  11808651  11860604  11878689  11911068  11948473 5Z93R5- 12236493;  12411746 7E64R2- 11933798; 7J53R2- 12172725; 7M13R1- 12168157; 7M14R1- 12349772; 7N16R- 12349786; 7P25R1- 12327801  12449801  12457250; 7P93R1- 12349795  12374420; 7Q11R1- 12344028  12456303; BB7L63R2- 12408737; BB7N26R- 12312571; CB5174R11- 11293051  11315344  11334856  11489271  11745162  11886341  11977682  12019852  12062713  12098852  12139621  12146752  12258941  12277502  12326468  12421465  206110946;  CB5175R13- 11292866  11334859  11432873  11442937  12182778  12411655;  CB5Q03R6- 11713162  11766245  11787583  11923139  11934952;  CB5Q03R7- 12114626; CB6C53R6- 12423767; CB7C15R2- 12411647; CB7C59R2- 11731501;  11813316  11838743  11869767  11908794  11982413  12019907  12146796  12151706  12201727  12292133  12423702; CB7C60R2- 11687047  11724030  11843434  11878672; CB7C74R2- 11895167; CB7D91R5- 11961280  12130493  12146882  12191604  12277455  12411687  12423760;  CB7E35R2- 11839101;  CB7E38R1- 11843886  11885844  11990360  12105025  12133083  12159400;  CB7G21R4- 12032413  12033728  12040524  12083359  12360622;  CB7L48R1- 12301694; CB7L72R1- 12155258; CB7P82R1- 12440601; HY6U96R2- 206133995; HY6Y52R2- 11826276; HY7E87R1- 11830948  11898103  11923498  12323794  12435409; SS7J91R3- 12175428; SSCB7L48R- 12120109; SSTL7G78R1 -11986264; TL5S33R7- 12093478;  12139612  12172589  12315375;  TL6V77R1- 11217931  11260111;  TL7B51R1- 11559097  11622968  11664762  11687063  11712834;  TL7G20R3- 12258680  12271138  12360554 TL7G78R3- 12067309; TL7R87R1- 206114578  206145379

Cardiovascular Devices

2

No

Worldwide Distribution--USA (nationwide) including the states of AZ, CA, CT, FL, GA, IL IA, MD, MA, MI, MS, NJ, NY, OH, OK, SC, TN, TX and WI. and the countries of CANADA and MALAYSIA.

Medtronic Intersept Custom Tubing Pack with or without coating ( Carmeda BioActive Surfact, Carmeda BioActive Surfact and Trillium Biosurface,or Balance Biosurface) with the following Model numbers: || 0E27R16, 1A30R6, 2493R24, 2493R25, 5D56R5, 5Z93R4, 5Z93R5, 7E64R2, 7J53R2, 7M13R1, 7M14R1, 7N16R, 7P25R1, 7P93R1, 7Q11R1, BB7L63R2, BB7N26R, CB5174R11, CB175R13, CB5Q03R6, CB5Q03R7, CB6C53R6, CB7C15R2, CB7C59R2, CB7C60R2, CB7C74R2, CB7D91R5, CB7E35R2, CB7E38R1, CB7G21R4, CB7L48R1, CB7L72R1, CB7P82R1, HY6U96R2, HY6Y52R2, HY7E87R1, SS7J91R3, SSCB7L48R, SSTL7G78R1,TL5S33R7, TL6VTTR1, TL7B51R1, TL7G20R3, TL7G78R3, TL7R87R1. || Sterilized Using Ethylene Oxide, Nonpyrogenic, Assembled in Mexico, Manufacturer Medtronic, Inc, Minneapolis, Mn 55432 || Product is used by perfusionists as part of the extracorporeal circuit during cardiopulmonary bypass procedures, and is configured specifically as designated by each customer.