Recall archive
453 recalls · page 3 of 19
Reported Apr 30, 2025
InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MMT-105ELBLNA, MMT-105ELGYNA, MMT105ELPKNA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed, Inc.
Matched: Brand — Insulin pens may have been incorrectly assembled therefore users could experience the following: either the insulin cartridge will not fit into the…
FDA (openFDA device enforcement)
Reported Apr 30, 2025
NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0, REF: NIM4CM01; CONSOLE NIM4CM01RF NIM 4.0 REFURBISHED,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Xomed, Inc.
Matched: Brand — Nerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead…
FDA (openFDA device enforcement)
Reported Apr 16, 2025
Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CABG OPNHRT S HSP,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.MEDLINE INDUSTRIES, LP - Northfield
Matched: Product · Product details · Reason for recall — Medline medical procedure kits, containing Medtronic Aortic Root Cannula
10 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 16, 2025
Stimulation RC Clinician Programmer Application, Model A71400, when used with the Inceptiv (Model 977119) and Intellis…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand — There is a software issue that can permanently disable communication with an implantable neurostimulator (INS) when a specific intraoperative…
FDA (openFDA device enforcement)
Reported Apr 9, 2025
A820 myPTM Software Application associated with Medtronic SynchroMed Pump and Infusion System.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Product · Product details — Product complaints were received describing the A820 myPTM app taking longer than expected for patients to interact with their implantable pump.
FDA (openFDA device enforcement)
Reported Mar 19, 2025
Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA 11012 AR FLOWGUARD 12GA, model no 11012 B. CANNULA 11014 AR…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Perfusion Systems
Matched: Brand — Unexpected loose material in the male luer used in the aortic root cannula has been identified. Potential harms when identified prior to use -…
FDA (openFDA device enforcement)
Reported Mar 12, 2025
Paradigm REF: MMT-712 and MMT-715
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic MiniMed, Inc.
Matched: Brand · Reason for recall — All Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin…
11 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 12, 2025
Medtronic Pipeline Vantage Embolization Device with Shield Technology, REF: PED3-027-350-12, PED3-027-350-14,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Micro Therapeutics, Inc.
Matched: Product · Product details — Use of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wall apposition and/or braid deformation…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 5, 2025
Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand · Product · Product details — Due to an increase in complaint that the percutaneous reference pin would not fit into the patient reference frame or percutaneous pin adapter.
FDA (openFDA device enforcement)
Reported Jan 29, 2025
DLP Pediatric One-Piece Arterial Cannulae, Model Numbers 77008 (8 Fr) and 77014 (14 Fr)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand — Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 22, 2025
Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.ev3 Inc.
Matched: Product · Product details — There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.
FDA (openFDA device enforcement)
Reported Jan 8, 2025
SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900B CLINICIAN TABLET EU -UK…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand — Software issues were identified in application version 2.x.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 25, 2024
Becker External Drainage and Monitoring System: 24146 EDMS 24146 BECKER NO Y-SITE 25120 EDMS II 25120 BECKER W/1-WAY…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Neurosurgery
Matched: Brand — Due to complaints received reporting cracks and/or leaks of the stopcocks associated with the external drainage and monitoring system (EDMS).
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 20, 2024
Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Product · Product details — The Wireless Rechargers in the kits may be unable to enter a recharging session upon first use.
FDA (openFDA device enforcement)
Reported Nov 13, 2024
Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand · Product · Product details — There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal
FDA (openFDA device enforcement)
Reported Oct 30, 2024
SynchroMed II Infusion Pump. Product Number: 8637-20
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand — Potential for error and inability to interrogate pump due to data corruption in the pump memory.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 23, 2024
MEDLINE HEART CABG CDS, REF CDS983376R
Moderate riskThis product could cause temporary or reversible health problems — stop using it.MEDLINE INDUSTRIES, LP - Northfield
Matched: Reason for recall — Medline Industries, LP. has identified certain kits containing the recalled Medtronic lots of the DLP Vessel Cannulae. During manufacturing of the…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 23, 2024
Vanta Implantable Neurostimulator (INS), Model 977006
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand — Model 977006 Vanta INS batterty life has depleted faster than HCPs or patients expected leading to outpatient reprogramming or earlier than…
FDA (openFDA device enforcement)
Reported Oct 18, 2024
Medtronic plc recalls Medtronic MiniMed™ 600 series or 700 series insulin pumps due to Device & Drug Safety - Defect
Risk not classifiedThe agency has not ranked the risk yet — treat the notice as a caution.Medtronic PLC
Matched: Brand · Product · Product details — Device & Drug Safety - Defect
FDA (recalls & safety alerts)
Reported Oct 16, 2024
StealthStation S8 App versions 1.3.0 and 1.3.2, (Model # 9735762) The StealthStation System, with StealthStation Spine…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand — Due to two software anomalies that can occur within a spine procedure. Two issues are: 1. Navigation Orientation - when lateral orientation…
FDA (openFDA device enforcement)
Reported Oct 9, 2024
MiniMed 630G Insulin Pump, REF: MMT-1515, MMT-1714, MMT-1715, MMT-1754, MMT-1755; MiniMed 700G Insulin Pump, REF:…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic MiniMed, Inc.
Matched: Brand — Insulin pumps that have been dropped, bumped, or experienced physical impact may have damage to internal electrical components, which may cause…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 25, 2024
2090 Programmers with serial number prefixes PKK0 and PKK1: a) 2090, Product Description: PRGM 2090 PROGRAMMER-PORTABLE…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand · Reason for recall — Medtronic CareLink 2090 programmers with serial number prefixes PKK0 and PKK1 have the potential for autonomous cursor motion when Finger Touchscreen…
FDA (openFDA device enforcement)
Reported Sep 18, 2024
Medtronic Handset with Communicator, Model TH90Q01, InterStim Smart Programmer and Communicator Kits, containing the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Product · Product details — A subset of the handsets within the kit may not be able to complete the pairing process with the communicator upon initial setup.
FDA (openFDA device enforcement)
Reported Sep 18, 2024
Medtronic DLP Single Stage Venous Cannulae with right angle metal tip, REF 67312
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand · Product · Product details — During manufacturing, DLP Single Stage Venous Cannulae - straight tip (Model 66118) was incorrectly placed into a product labeled as DLP Single Stage…
FDA (openFDA device enforcement)
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