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44 reported ongoing
45 records in this archive. Latest source date Mar 11, 2026.
FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
Ventricular fibrillation (VF) occurred during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who have a Biotronik Implantable Cardioverter Defibrillator (ICD) or Biotronik Cardiac Resynchronization Therapy-Defibrillator (CRT-D)...
Class IIReported ongoing
Distribution: Worldwide
Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in stent migration.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide and the countries of Argentina, Australia, Austria, Belgium, Chile, Colombia, Costa Rica, Denmark, Dominican Republic, Finland, Germany, Jordan, Lebano...
There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution.
In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy ...
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution.
In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy ...
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution.
A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon interrogation with a SmartSync Device Manager. The erroneous m...
Class IIReported ongoing
Distribution: Worldwide
A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon interrogation with a SmartSync Device Manager. The erroneous m...
Class IIReported ongoing
Distribution: Worldwide
Identified devices may experience sudden battery power failure without alarm, power supply power-on-resets, and interruption of therapy. Potential patient harms include insufficient pacing support leading to cardiac arrest, syncope, or hospitalization; or s...
Class IIReported ongoing
Distribution: International distribution of the country of UK. No US distribution.
Medtronic CareLink 2090 programmers with serial number prefixes PKK0 and PKK1 have the potential for autonomous cursor motion when Finger Touchscreen capability is enabled by software version 3.2 or higher.
Class IIReported ongoing
Distribution: Worldwide distribution.
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, ...
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, ...
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, ...
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, ...
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, ...
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, ...
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, ...
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, ...
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, ...
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, ...
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Class IIReported ongoing
Distribution: Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, ...
These examples come from this result page and are not a ranking of every recall reason.
This archive contains 45 records, including 44 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.
Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.
A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.
This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.
Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.