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Medtronic Sofamor Danek USA Inc

Medtronic Sofamor Danek USA Inc Recalls

All product recalls associated with Medtronic Sofamor Danek USA Inc.

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Recall Summary

Total Recalls

606

Past Year

Class I (Serious)

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 401–420 of 606 recalls

Medtronic Sofamor Danek USA Inc: Satellite Spinal System Surgical Technique, LITSATFUSST7-...

Surgical manual/technique lack information required as a condition of the 510(k) approval.

FDASep 13, 2007Nationwide• Medtronic Sofamor Danek USA Inc

Medtronic Sofamor Danek USA Inc: Medtronic Sofamor Danek, Prestige Cervical Disc System, I...

Implant mis-seating; Variance in size between the trial and the implant could cause the implant to be improperly seated.

FDASep 4, 2007Nationwide• Medtronic Sofamor Danek USA Inc

Medtronic, Inc.: Medtronic Export XT Aspiration Catheter, 6F (US) Medtroni...

Additional Warning in Instructions for Use for guide wire management. Complaints of wire lumen tearing during use or band marker becoming dislodged.

FDA

1...19 202122 23...31

Page 21 of 31Next

Aug 29, 2007

Nationwide

• Medtronic, Inc.

Medtronic Inc. Cardiac Rhythm Managment: Medtronic Paceart System, 2006 Edition, Medtronic, Inc. 7...

An issue with the Paceart System - 2006 First Edition (Get Connected Edition) exists. Under certain circumstances, Paceart System Generic ICD reports may not accurately reflect patient VT/VF, SVT/NST and Mode Switch/AT/AF episode detection data. When episode detection data is imported into the Paceart System from certain sources, the Paceart System Generic ICD reports display a zero, suggesting

FDAAug 27, 2007Nationwide• Medtronic Inc. Cardiac Rhythm Managment

Medtronic Sofamor Danek USA Inc: Medtronic Sofamor Danek, TSRH SiLo 5.5 Spinal System, Sag...

Disassembly: The movable cradle component could detach from the saddle under extreme manipulation of the associated rods prior to final tightening of the set screws.

FDAAug 24, 2007Nationwide• Medtronic Sofamor Danek USA Inc

Medtronic Emergency Response Systems, Inc.: biphasic LIFEPAK 500 automated external defibrillators (A...

Reduced Shock- the device may deliver 100 Joule (J) to a patient, which is less than the recommended factory minimum default setting of 200 J.

FDAJun 13, 2007Nationwide• Medtronic Emergency Response Systems, Inc.

Medtronic Emergency Response Systems, Inc.: LIFEPAK 20 defibrillator/monitor. The device is an AC pow...

White Screen Lock up: LifePak 20 defibrillators with software version 48 or version 52 may experience an intermittent timing issue during the power on sequence. This may lock up the device resulting in the monitor screen going white, and may cause a potential delay or prevention of shock treatment.

FDAApr 27, 2007IN, OR• Medtronic Emergency Response Systems, Inc.

Medtronic Emergency Response Systems, Inc.: LIFEPAK 20 defibrillator/monitor. The device is an AC po...

Defibrillator internal battery cell may contain a short which could reduce battery capacity and cause the device to shut down without warning while operating on backup (DC) battery power.

FDAMar 30, 2007IN• Medtronic Emergency Response Systems, Inc.

Medtronic Emergency Response Systems, Inc.: Batteries used with the LIFEPAK 20 defibrillator/monitor

Defibrillator internal battery cell may contain a short which could reduce battery capacity and cause the device to shut down without warning while operating on backup (DC) battery power.

FDAMar 30, 2007IN• Medtronic Emergency Response Systems, Inc.

Medtronic Emergency Response Systems, Inc.: LIFEPAK CR Plus defibrillator. The device is a battery o...

LIFEPAK CR Plus defibrillators with software version 1.16 or lower may miscalculate the HLC battery capacity and result in the CHARGE-PAK battery charger icon/indicator to display and falsely indicate battery needs replacement.

FDAMar 2, 2007IN, OR• Medtronic Emergency Response Systems, Inc.

Medtronic Inc. Cardiac Rhythm Managment: Vitatron T-Series Dual Chamber pacemaker T60 DR, model T6...

Pacing rate: Software anomaly affecting Vitatron dual chamber C-series and T-series pacemakers, related to automatic retrograde conduction testing, can inhibit the device from pacing if the patient's intrinsic rate falls below the programmed lower rate.

FDAFeb 5, 2007AL, AZ, AR +19 more• Medtronic Inc. Cardiac Rhythm Managment

Medtronic Inc. Cardiac Rhythm Managment: Vitatron C-Series C60DR DDDR Dual Chamber Rate Responsive...

Pacing rate; Software anomaly affecting Vitatron dual chamber C-series and T-series pacemakers, related to automatic retrograde conduction testing, can inhibit the device from pacing if the patient's intrinsic rate falls below the programmed lower rate.

FDAFeb 5, 2007AL, AZ, AR +19 more• Medtronic Inc. Cardiac Rhythm Managment

Medtronic Sofamor Danek USA Inc: Colorado 2 Spinal System, Anterior Plate, REF8639500, for...

Bone screws may pull though the plate.

FDAFeb 2, 2007Nationwide• Medtronic Sofamor Danek USA Inc

Medtronic Xomed, Inc.: AccuGuide Injection Needles (Surface electrodes) The A...

A labeling discrepancy was internally identified for the surface electrode component of REF 8263210 AccuGuide EMG Injection Needle, 30G X 25MM. The outside box label correctly indicates 'Content: 5 sterile Injection Needles and 10 non-sterile Surface electrodes'; however, the pouches for the 10 surface electrodes inside the box are incorrectly labeled as 'sterile'.

FDAJan 22, 2007Nationwide• Medtronic Xomed, Inc.

Medtronic Sofamor Danek USA Inc: Medtronic Sofamor Danek Bone fragmentor Ref Number/Model ...

Metal bone fragmentor was causing metal shavings to be released into the resultant fragmented tissue during use.

FDAOct 20, 2006Nationwide• Medtronic Sofamor Danek USA Inc

Medtronic Emergency Response Systems, Inc.: LIFEPAK EXPRESS defibrillator

Premature battery depletion due to electrical component failure

FDAOct 5, 2006IN• Medtronic Emergency Response Systems, Inc.

Medtronic Emergency Response Systems, Inc.: LIFEPAK CR Plus defibrillator

Premature battery depletion due to electrical component failure

FDAOct 5, 2006IN• Medtronic Emergency Response Systems, Inc.

Medtronic Emergency Response Systems, Inc.: LIFEPAK 20 external defibrillator/monitor

Devices with v38 system software do not display a ''LOW BATTERY: CONNECT TO AC POWER'' message when the monitor is on backup (DC) battery power and may shut down without warning.

FDAAug 30, 2006Nationwide• Medtronic Emergency Response Systems, Inc.

Medtronic, Inc.: CATH. GUIDE 8F SR4.0 W/SH LAUN CATHETER LA8SR40SH LA 8F 1...

Potential for non-sterility due to loss of package integrity

FDAApr 5, 2006Nationwide• Medtronic, Inc.

Medtronic, Inc.: 8F ZUMA 2 SR 3.0 100CM CATHETER Z28SR30 Z2 8F 100CM SR30 ...

Potential for non-sterility due to loss of package integrity

FDAApr 5, 2006Nationwide• Medtronic, Inc.