St. Jude Medical Ellipse VR/DR Implantable Cardioverter Defibrillators (ICDs)Models: CD1277 (-36 and -36Q) , CD1377 (-36, -36Q, -36C and -36QC), CD2277 (-36 and -36Q), CD2377 (-36, -36Q, -36C and -36QC) Serial Numbers: beginning with “1” that are below 1132470, beginning with the number “7” that are below 7126267 and all serial numbers beginning with an “8” are affected.ARTG Numbers: 207181, 207182, 207183, 207184, 207185, 207186, 207187, 207189, 202934, 202938, 198821, 198822

Cardiovascular Devices

RF enabled St. Jude Medical Ellipse, Fortify Assura, Unify Assura, and Quadra Assura Implantable Cardioverter Defibrillators (ICDs) and Assurity and Allure Pacemakers when used with Merlin@home RF Remote Monitoring Transmitter Model EX1150All model numbers affected ARTG Number (Merlin@home Remote Monitoring System): 161670

St. Jude Medical ICD/CRT-D devices programmed to a single VF detection zone with Merlin Programmer software version 17.2.2 rev. 0Affected ICD/CRT-D devices: Current/Promote/AnalyST, Unify/Fortify, Assura and Ellipse families Multiple ARTG numbers for ICD/CRT-D devicesARTG number for the Merlin Programmer: 124262

St. Jude Medical: All models of RF enabled St. Jude Medical Ellipse™, Fortify Assura™, Unify Assura™, and Quadra Assura™ implantable cardioverter defibrillators (ICDs) and Assurity™ and Allure™ pacemakers when used with Merlin@home™ RF Remote Monitoring Transmitter Model EX1150.

St. Jude Medical (Abbott): St. Jude Medical Infinity™ DBS System (8-Channel)

Cardiovascular Devices

Implantable Cardioverter Defibrillator: St. Jude Medical Fortify™, Fortify Assura™, Quadra Assura™, Quadra Assura MP™, Unify™, Unify Assura™ and Unify Quadra™. Priority 1 – For Immediate Action

Model No.: 6172ANS, 6170ANS Multiple batch & serial numbers (See attached FSN) UDI: 05415067020635, 05415067030306, 05415067020680, 05415067030320

Implantable Pulse Generators

Merlin PCS 3650 Software Upgrade Kit, St. Jude Medical, Cardiac Rhythm Management Division

1. Merlin PCS 3650 Software Upgrade Kit , 2. Merlin@home Transmitter Software, 3. High Voltage Device ICD and CRT-D (model name Fortify™, Fortify Assura™, Quadra Assura™, Quadra Assura MP™, Unify™, Unify Assura™, Unify Quadra™, Promote Quadra™ and Ellipse™), St. Jude Medical, Cardiac Rhythm Management Division

Lot number range: 1169725 to 1181488 EXPANDED RECALL additional lot numbers are: 1182741, 1182742, 1182743, 1182744, 1182745, 1184211, 1185314, 1186554, 1186557.

Cardiovascular Devices

2

No

World wide- USA states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KS, KY, LA, MD, MI, MN, MO, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV. ---Foreign includes: Austria, Belgium, Denmark, France, Germany, Great Britain, Italy, Lichtenstein, Netherlands, Norway, South Africa, Spain, Sweden, Switzerland, United Kingdom

St. Jude AGILIS Steerable Introducer, Reorder number 408304 and 408308 (Australia). Sterile EO. St. Jude Medical Daig Division, Inc., Minnetonka, MN 55345-2126 USA. This St. Jude Medical (SJM) Agilis Steerable Catheter Introducer Set consists of a dilator, guidewire, and steerable sheath, which is designed to provide flexible catheter positioning in the cardiac anatomy. The steerable introducer is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling and pressure monitoring. A handle equipped with a rotating collar to deflect the tip clockwise >than or equal to 180-degrees and counter-clockwise >than or equal to 90-degrees. The steerable introducer features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization. EXPANDED RECALL The Reorder number affected by the recall expansion is 408304.

All lots with a manufacturing date of May 30, 2006 or earlier

Cardiovascular Devices

2

No

Hospitals/Medical Centers in AZ, CA, MS, NY, & PA

CPS Valve Bypass Tool (VBT), Model 410192

All lots with a manufacturing date of May 30, 2006 or earlier

Cardiovascular Devices

2

No

Hospitals/Medical Centers in AZ, CA, MS, NY, & PA

CPS Direct SL, Models 410110, 410111, 410112, 410113, 410114, 410115, 410116, 410120, 410121, 410122, 410123, 410124, 410125, & 410126

All lots with a manufacturing date of May 30, 2006 or earlier

Cardiovascular Devices

2

No

Hospitals/Medical Centers in AZ, CA, MS, NY, & PA

CPS Aim, Models 410140, 410141, 410142, 410144, 410145, 410146, 410147, & 410148

All lots with a manufacturing date of May 30, 2006 or earlier

Cardiovascular Devices

2

No

Hospitals/Medical Centers in AZ, CA, MS, NY, & PA

CPS Implant Kit, Model 410190

All lots with a manufacturing date of May 30, 2006 or earlier

Cardiovascular Devices

2

No

Hospitals/Medical Centers in AZ, CA, MS, NY, & PA

CPS Slitter, Model 410191

Lot Number: 6372

Cardiovascular Devices

2

No

Worldwide Distribution -- US (CA, MI, PA and TN), China and Belgium.

St. Jude Medical FAST-CATH Hemostasis Introducer 7F, REF 406702, Length 12 CM, Lot 6372 Max. Guidewire O.D. .038", 2010-01, Manufacturer, St. Jude Medical, 14901 DeVeau place, Minnetonka, MN 55345-2126, Sterile EO. || Used for the introduction of catheters into a vessel.

Lot Number: 4219

Cardiovascular Devices

2

No

Worldwide Distribution -- US (CA, MI, PA and TN), China and Belgium.

St. Jude Medical FAST-CATH Hemostasis Introducer 4F, REF 406709, Length 12 CM, Lot 4219 Max. Guidewire O.D. .038", 2010-01, Manufacture, St. Jude Medical, 14901 DeVeau place, Minnetonka, MN 55345-2126, Sterile EO. || Used for the introduction of catheters into a vessel.

All kits containing Triad alcohol prep pads

Hematology and Pathology Devices

2

No

Worldwide Distribution - USA (nationwide) and Germany

Heritage Labs St. Jude Childhood Cancer Study Kit, Product A1185. Each kit contains 1 Triad Medium Alcohol Prep Pad, Cat. No. 10-3001, NDC 50730-3001-0 and blood specimen collection supplies. || Blood specimen collection