Recall archive
453 recalls · page 11 of 19
Reported Nov 6, 2019
Programmers & Remote Monitoring Software Apps: 2090 CareLink Programmer
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand · Reason for recall — There is a potential for Medtronic programmer and remote monitoring software applications to display an inaccurate remaining longevity estimate for a…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 23, 2019
Euphoria Rapid Exchange Balloon Dilatation Catheter, Product Numbers: EUP1506X, EUP1510X, EUP1512X, EUP1515X, EUP1520X,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Vascular Galway dba Medtronic Ireland
Matched: Brand · Reason for recall — Medtronic has determined that some catheters have a slightly higher diameter stylette causing removal difficulties.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 9, 2019
SHERPA NX ACTIVE GUIDING CATHETER, 6F, IMA 55CM .070", REF SA6IMAK. for cardiovascular use
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Vascular
Matched: Brand — There is a potential for extensive loss of primary segment material exposing underlying stainless-steel braid wires on a subset of 6F Sherpa…
190 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 18, 2019
Medtronic Micra MC1VR01, Single chamber transcatheter pacing system, REF MC1VR01US (US only). Cardiac pacemaker.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand · Product · Product details · Reason for recall — Medtronic is updating the Micra Instructions for Use (IFU) and the Micra Implant Procedure Tip Card to include specific information on the removal of…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 10, 2019
Medtronic 0-arm TM 1000 Imaging Systems: Bl-700-00027-XXX and B1-700-00028-XXX (where XXX indicates the system…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.-Littleton
Matched: Brand · Product · Product details — The 0-arm 1000 Imaging System uses energy from the batteries to generate X-rays and move the system. If a charger board is not functioning properly,…
FDA (openFDA device enforcement)
Reported Jul 3, 2019
Mosaic 310 Bioprosthesis, Mitral, REF 310C29 - Product Usage: Replacement of malfunctioning native or prosthetic aortic…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand — Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size. In all cases, the actual surgical heart valves are…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 19, 2019
InterStim(TM) System, Model Numbers: a) TH90G01 b) TH90GFA c) TH90G02 d) TH90G03 Product Usage: The Medtronic Model…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Product · Product details · Reason for recall — There is a potential for an unexpected increase in stimulation during InterStim programming with the A10 Clinician Application (on Medtronic's smart…
FDA (openFDA device enforcement)
Reported May 15, 2019
Guardian Connect App CSS7200 used on the iPhone, iPad, and iPod Touch devices.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand — The application may be closed by the operating system without alerting the user the app is no longer running or communicating with the transmitter…
FDA (openFDA device enforcement)
Reported Apr 3, 2019
Medtronic Pulmonary Vein Ablation Catheter(R) GOLD (PVAC GOLD) 990078 - Product Usage: The Pulmonary Vein Ablation…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand · Product · Product details — The firm issued an updated instructions for use to reduce the potential for phrenic nerve injury.
FDA (openFDA device enforcement)
Reported Feb 27, 2019
Medtronic Power Supply 26907, Medtronic CareLink Encore(TM) 29901 Programmer
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand · Product · Product details · Reason for recall — There is a potential for an electrical short circuit to develop in a subset of 479 Model 26907 power supply cable plugs that connect to the Medtronic…
FDA (openFDA device enforcement)
Reported Feb 20, 2019
Medtronic implantable pulse generator: ADAPTA, Dual chamber pacemaker (DDD): (a) Model Number ADD01 (b) Model Number…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand · Product · Product details · Reason for recall — A subset of Medtronic dual chamber pacemakers distributed worldwide between 10 March 2017 and 7 January 2019 under the brand names Adapta, Versa, and…
6 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 13, 2019
MEDTRONIC CARELINK 2090 programmer
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand · Product · Product details — There is an error in how the programmer calculates and displays the remaining longevity value during a period of time (up to 2 years) prior to the…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 6, 2019
RESERVOIR "Y" ADAPTER, (a) BT920 (b) BT926 Suction and Anticoagulation assemblies are indicated for use with an…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand · Reason for recall — Medtronic discovered that certain Y-connectors included in the suction lines have exhibited tearing and cracking. These defects could cause the…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jan 9, 2019
StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cranial Optical Pocket Guide - Instructions for…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Navigation, Inc.
Matched: Brand · Product details — An incorrect display of the Biopsy Depth Gauge graphical representation in the Guidance View using Cranial software, which resulted in the biopsy of…
FDA (openFDA device enforcement)
Reported Jan 2, 2019
Medtronic MiniMed 630G 6025805-003_C, Rx Only Medtronic MiniMed 670G 6025805-005_B, Rx Only Medtronic MiniMed 640G…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand · Product · Product details — Reports of occurrences in which insulin pumps with version 4.10 software have failed to make expected audio sounds during alerts, alarms or sirens.…
FDA (openFDA device enforcement)
Reported Dec 19, 2018
Medtronic HeartWare Ventricular Assist HVAD System Battery Charger Model 1600US - Product Usage: The HeartWare…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Heartware, Inc.
Matched: Product · Product details — HVAD Battery Charger units manufactured with wrong inductors.
FDA (openFDA device enforcement)
Reported Nov 21, 2018
Parietex Composite Parastomal Mesh (Product Number PCOPM15 / PCOPM20) Product Usage: The PCOPM15 and PCOPM20 reorder…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien LLC
Matched: Reason for recall — The firm is issuing this voluntary removal following receipt of reports of parastomal mesh failure identified several years following parastomal…
FDA (openFDA device enforcement)
Reported Nov 21, 2018
INFUSE Bone Graft X SMALL KIT REF 7510100
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA Inc.
Matched: Brand — The Extra Small INFUSE Bone Graft kit from lot M111806AAA, may contain two absorbable collagen sponges (ACS), but should only contain one ACS.
FDA (openFDA device enforcement)
Reported Nov 14, 2018
Medtronic CareLink 2090 Programmer
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Matched: Brand · Product · Product details · Reason for recall — Vulnerabilities have been identified in the SDN download process that may allow an individual with malicious intent to update the programmers with…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 14, 2018
Medtronic Navigation 0-arm 02 Imaging System interventional fluoroscopic x-ray system: OARM BI70002000 SYS IMAGING 02…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.-Littleton
Matched: Brand · Product · Product details — O-arm 02 Imaging Systems correction to software version 4.1.0; new version of the user manual and an Image Acquisition System ("IAS") product label;…
FDA (openFDA device enforcement)
Reported Oct 31, 2018
O-arm 1000 2nd Edition Imaging System, OARM ASSY Bl70000027 SYSTEM PRODUCT, Model Number Bl70000027 Product Usage: The…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.-Littleton
Matched: Brand — Software anomalies were reported to affect the following system functionalities: startup and shutdown, system and network communication, motion…
9 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 3, 2018
Visualase Thermal Therapy System, Software: Visualase Software versions 3.1.1 - 3.2, Product #: 9735542
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand · Reason for recall — Inaccuracy of MR thermometry during MRI-guided laser ablation procedures using the Medtronic Visualase Thermal Therapy System may result in…
FDA (openFDA device enforcement)
Reported Oct 3, 2018
Medtronic Clip Gun Magazines are packaged in individually sealed pouches and distributed in boxes containing 5…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neurosurgery
Matched: Brand · Product · Product details — The packaging sterile barrier does not comply with the applicable packaging standard for terminally sterilized medical devices. While the…
FDA (openFDA device enforcement)
Reported Oct 3, 2018
Medtronic DxTerity(TM) TRA 5F, Diagnostic Catheter, REF U5TRAN35
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Medtronic Vascular
Matched: Brand · Product · Product details · Reason for recall — Medtronic has determined that the French size indicator on the inner pouch may incorrectly reflect a 6 French size, rather than the correct 5 French…
FDA (openFDA device enforcement)
RecallNow is not a government agency. Every notice above is published by the FDA, USDA FSIS, or CPSC and links back to its source. Back to the look-up