Stay Informed

Get email alerts when new recalls match your interests.

Recall data is updated hourly from official government sources. Very recent recalls may not yet appear. About our data sources

About

We make U.S. recall data searchable and accessible for consumers and businesses.

Site

FAQ
Browse by State
Statistics
Recall Classifications
About
Enterprise API

Legal

Privacy Policy
Terms of Service
Report Incorrect Info

Official Sources

FDA Recalls ↗
USDA FSIS ↗
CPSC Recalls ↗
NHTSA Recalls ↗

RSS Feed

Home
/
Brands
/
Medtronic Sofamor Danek USA Inc

Medtronic Sofamor Danek USA Inc Recalls

All product recalls associated with Medtronic Sofamor Danek USA Inc.

Get alerts for this brand

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 361–380 of 606 recalls

Medtronic Sofamor Danek USA Inc: Medtronic SOFAMOR DANEK INTREPID SPINAL SYSTEM, 5.5MM TAP...

The firm received complaints regarding the use of the product in patients with poor bone quality, translational instability, difficulty implanting the cover plate and case of cover plate detachment.

FDAFeb 6, 2009Nationwide• Medtronic Sofamor Danek USA Inc

Medtronic Sofamor Danek USA Inc: Medtronic INTREPID Spinal System SPACER, 32X23, 8 DEG, Si...

The firm received complaints regarding the use of the product in patients with poor bone quality, translational instability, difficulty implanting the cover plate and case of cover plate detachment.

FDAFeb 6, 2009Nationwide• Medtronic Sofamor Danek USA Inc

Medtronic Spine LLC, formerly Kyphon Inc: KyphX Xpander Inflatable Bone Tamp, size 15/3, Catalog Nu...

Product not sterile: 10 units were released for distribution without undergoing sterilization process.

1...17 181920 21...31

Page 19 of 31Next

FDAFeb 4, 2009FL, IN, OH• Medtronic Spine LLC, formerly Kyphon Inc

Medtronic Inc: Medtronic Mosaic Porcine Bioprostheses with Cinch, Heart ...

Medtronic identified several heart valves (Mosaic Porcine Bioprosthesis with Cinch & Hancock II Bioprosthesis with Cinch) that were inadvertently distributed after exposure to temperatures exceeding the 77 F (25 C) maximum storage temperature published on the labeling. The product is being retrieved as they do not meet the handling requirements.

FDAJan 26, 2009Nationwide• Medtronic Inc

Medtronic Inc: Hancock II Bioprostheses with Cinch, Heart Valve, Model #...

FDAJan 26, 2009Nationwide• Medtronic Inc

Medtronic Xomed, Inc.: VARI-STIM III Nerve Locator/Stimulator, Sterile, Medtroni...

Device may fail to operate or operate intermittently during use and such operation could result in a lack of nerve stimulation when nerve tissue is actually contacted by the stimulator.

FDANov 21, 2008Nationwide• Medtronic Xomed, Inc.

Medtronic Inc. Cardiac Rhythm Managment: Medtronic RV Lead Integrity Alert , Cat. # SW012, 1.0 sof...

Medtronic has identified an issue related to installation or removal of the Lead Integrity Alert software in EnTrust(R) and EnTrust(R) Escudo" defibrillators. In those devices only, installation or removal of LIA will inadvertently turn off two audible patient alerts.

FDANov 3, 2008AL, AK, AZ +48 more• Medtronic Inc. Cardiac Rhythm Managment

Medtronic Inc: Medtronic Surgical Membrane Oxygenator. Mis-printed Labe...

Medtronic has identified an issue with the labeling of the I-4500 Silicone Oxygenators (P/N 61399402655). Lot numbers of this oxygenator manufactured between August 2007 and September 2008 have an incorrect "Recommended maximum blood flow range" on the label. The label on the device states a range of 5.0 - 8.5 L/min but should state a range of 5.0 - 6.5 L/min. These oxygenators are acceptable t

FDAOct 17, 2008CA, CO, FL +19 more• Medtronic Inc

Medtronic, Inc.: 7 F BardSelect 11cm Percutaneous Catheter Introducer Set...

Failure to insert the guidewire through the 18 gauge introducer needle

FDAOct 7, 2008FL, IL• Medtronic, Inc.

Medtronic, Inc.: 6 F BardSelect 11cm Percutaneous Catheter Introducer Set...

Failure to insert the guidewire through the 18 gauge introducer needle

FDAOct 7, 2008FL, IL• Medtronic, Inc.

Medtronic, Inc.: Medtronic Input TS 7F 11 cm Ref: 071102A Percutaneous c...

Failure to insert the guidewire through the 18 gauge introducer needle

FDAOct 7, 2008FL, IL• Medtronic, Inc.

Medtronic, Inc.: 5 F BardSelect 11 cm Percutaneous Catheter Introducer Set...

Failure to insert the guidewire through the 18 gauge introducer needle

FDAOct 7, 2008FL, IL• Medtronic, Inc.

Medtronic Inc. Cardiac Rhythm Managment: Medtronic Attain LDS 6216A, Left-heart delivery system. ...

Medtronic has identified an issue with the packaging for specific lots of the Medtronic Adjustable Valve and valves contained in the Attain Left Heart Delivery System kits. A small number of valve package seals could be compromised.

FDAAug 27, 2008GA, OR, RI +3 more• Medtronic Inc. Cardiac Rhythm Managment

Medtronic Inc. Cardiac Rhythm Managment: Medtronic Adjustable Valve, 6248VAL, Sterilized using irr...

FDAAug 27, 2008GA, OR, RI +3 more• Medtronic Inc. Cardiac Rhythm Managment

Medtronic Inc. Cardiac Rhythm Managment: Medtronic Attain ACCESS 6218A, Left-heart delivery syste...

FDAAug 27, 2008GA, OR, RI +3 more• Medtronic Inc. Cardiac Rhythm Managment

Medtronic Inc. Cardiac Rhythm Managment: Maximo II CRT D284TRK, for ventricular pacing and defibri...

Maximo II VR ICD, DR ICD and CRT-D inadvertently include the Capture Management algorithm (Atrial/Right Ventricular/Left Ventricular Capture management). The Capture management algorithm monitors daily pacing thresholds and may increase or decrease pacing amplitudes in response to patients' needs. Although the algorithm is operating correctly, it is not accessible to the clinician for reprogramm

FDAJul 25, 2008Nationwide• Medtronic Inc. Cardiac Rhythm Managment

Medtronic Inc. Cardiac Rhythm Managment: Medtronic Maximo II VR D284VRC, for ventricular pacing an...

FDAJul 25, 2008Nationwide• Medtronic Inc. Cardiac Rhythm Managment

Medtronic Inc. Cardiac Rhythm Managment: Medtronic Maximo II DR D28DRG, for ventricular pacing an...

FDAJul 25, 2008Nationwide• Medtronic Inc. Cardiac Rhythm Managment

Medtronic Navigation, Inc.: BI-700-00027 0-arm 1000 Imaging System Mobile X-ray Syste...

Failure to of affected units to comply with EER/AKR limits due to misinterpretation of the measurement requirements specified in 21 CFR 1020.32 (d) (3) (iii)

FDAJun 30, 2008CA, FL, IN +5 more• Medtronic Navigation, Inc.

Medtronic International Trade Inc: Medtronic Trillium AFFINITY NT, 511T, Hollow Fiber Oxygen...

Medtronic is advising that certain Trillium-coated Medtronic cardiopulmonary bypass (CBP) products (e.g., oxygenators, reservoirs, pumps and tubing packs) were manufactured with heparin batches contaminated with oversulfated chondroitin sulfate (OSCS). Based upon currently available information, Medtronic has determined that Medtronic Trillium-coated products can continue to be used in cardiopulm

FDAMay 7, 2008Nationwide• Medtronic International Trade Inc