Recall archive
444 recalls · page 13 of 19
Reported Aug 30, 2017
Medtronic Straight Suction 9733449 EM ENT, reusable, Rx. The firm name on the label is Medtronic Navigation, Inc.,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand · Product · Product details — The instruments are not able to pass instrument verification which is performed prior to the use of each instrument.
7 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 30, 2017
DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead kits, models 3387/3387S, 3389/3389S, and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Product · Product details · Reason for recall — Medtronic received reports that the DBS depth stop did not adequately secure to the lead, which can result in DBS lead placement beyond the intended…
FDA (openFDA device enforcement)
Reported Aug 9, 2017
SORIN GROUP, SMART PERFUSION PACK, LONG PACK, REF 088512600, STERILE EO, Rx Only, 1 EA
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Sorin Group USA, Inc.
Matched: Reason for recall — Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes…
15 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 2, 2017
Medtronic Visualase(R) Cooled Laser Applicator System (VCLAS) 15MM TIP, REF 9735561, (1) Laser Diffusing Fiber - 600um…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand · Product · Product details · Reason for recall — Medtronic has become aware that the VCLAS 15MM TIP cap, also referred to as Tuohy Borst Adapter (TBA), may not be capable of creating a seal around…
FDA (openFDA device enforcement)
Reported Aug 2, 2017
DLP Extension Line Adapters 20 in length Used to extend cardioplegia line during cardiopulmonary bypass surgery
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Perfusion Systems
Matched: Brand — Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 26, 2017
Install CD, Spine tools, Plus and S7, Version 25. Model Number 9731958.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Navigation, Inc.
Matched: Brand — Software issue related to the StealthStation S7 system and the Synergy Spine application Version 2.1 configured with Spine Tool Install CD version…
FDA (openFDA device enforcement)
Reported Jun 28, 2017
MiniMed 620G Insulin Infusion Pump, Catalog No. MMT-1510, MMT-1710, MMT-1550, MMT-1750.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand · Reason for recall — Medtronic MiniMed is recalling the MiniMed 600 series insulin pump because it may become temporarily stuck, and the keypad becomes unresponsive.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 21, 2017
Sutures. POLYSORB: POLSORB 0 18 U/D PRECUT 126R, Item Number: L4; POLSORB 0 18 VIO PRECUT 226T; Item Number: L14;…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic
Matched: Brand — Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.
7 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 14, 2017
KYPHON(R) Directional Bone Filler Device, Size: 3, REF F04C, Rx Only, STERILE R.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA Inc.
Matched: Brand — The directional arrow at the proximal end of the instrument may not correctly align with the cutout opening on the distal end of the instrument.…
FDA (openFDA device enforcement)
Reported May 31, 2017
Amplia MRI Quad CRT-0 SureScan Claria MRI Quad CRT-D SureScan Compia MRI Quad CRT-D SureScan
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc., Cardiac Rhythm and Heart Failure
Matched: Brand · Reason for recall — An unexpected transient mode switch behavior was detected by Medtronic during systems testing that affects Amplia' "', Claria'"', and Compia'"' Quad…
FDA (openFDA device enforcement)
Reported May 17, 2017
Medtronic PAK NEEDLE BEVELED AND TROCAR TIPS, REF 8670009, QTY 1 EA, STERILE R, Rx only
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA Inc.
Matched: Brand · Product · Product details — Product packaging may incorrectly include two bevel-tipped needles or two trocar-tipped needles instead of one diamond-tipped needle and one…
FDA (openFDA device enforcement)
Reported May 10, 2017
BD FlowSmart Set MiniMed Pro-set Rx Only Distributed by Medtronic MiniMed Inc. 8006464633 8185765555 Legal Manufacturer…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Becton Dickinson & Company
Matched: Product · Product details — Patients are reporting high blood glucose (HBG) levels while using the MiniMed Pro-set and also noticed the catheter of the infusion set was…
FDA (openFDA device enforcement)
Reported May 10, 2017
MiniMed 620G and MiniMed 640G Insulin Pumps with Software Version 2.6 and below are affected. Catalog Numbers for these…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Inc.
Matched: Brand · Reason for recall — Medtronic has identified a software anomaly that can prevent the internal battery of the pump from charging. When the software anomaly occurs it…
FDA (openFDA device enforcement)
Reported May 10, 2017
Newport Medical HT70 and HT70- Plus Ventilators, Rx Only Product Usage: The Newport HT70 family of ventilators is…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Newport Medical Instruments Inc.
Matched: Reason for recall — Medtronic is issuing a voluntary field corrective action for all its Newport" HT70 and Newport" HT70 Plus ventilators because they may shutdown…
FDA (openFDA device enforcement)
Reported Apr 26, 2017
Valleylab Laparoscopic Handset; Material # E2750; Laproscopic Handset Non-Sterile Bulk; Material # E2750NSB Product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Covidien Medtronic
Matched: Brand — Customer reports of the device handset continuing to operate after release of the activation button.
FDA (openFDA device enforcement)
Reported Apr 19, 2017
The Medtronic StrataMR adjustable valves and shunts are designed to provide continuous cerebrospinal fluid (CSF) flow…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Neurosurgery
Matched: Brand · Product · Product details — Incorrect valve rotor orientation due to misalignment and/or off-center positioning of the StrataMR Locator Tool: When the StrataMR valve is set in…
FDA (openFDA device enforcement)
Reported Apr 19, 2017
Cataract Kit, part numbers CAT1467AM and CAT1538(B. Product packaged in a convenient manner for use in a general…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Windstone Medical Packaging, Inc.
Matched: Reason for recall — AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be…
17 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 5, 2017
SynchroMed II implantable drug infusion pump, Model 8637-40,
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Neuromodulation
Matched: Brand · Reason for recall — Medtronic received a complaint that there was an error code displayed on the programmer when the physician attempted to interrogate an implanted…
FDA (openFDA device enforcement)
Reported Mar 29, 2017
Poly Component Trial, MPCS, packaged in the following sizes and configurations: a) Poly Component Trial - MPCS 3x10L,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Sofamor Danek USA Inc.
Matched: Brand — The dovetails of poly trials, Beta 2.0, were observed as either cracked or broken.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 29, 2017
Endurant / Endurant II 23mm and 25mm Bifurcated Stent Graft Systems Model Numbers: ETBF2516C145E ETBF2516C166E…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Vascular, Inc.
Matched: Brand · Reason for recall — Medtronic is initiating a voluntary Urgent Medical Device Recall for a subset of Endurant/ Endurant II Bifurcated Stent Graft Systems of specific…
FDA (openFDA device enforcement)
Reported Mar 22, 2017
BNX Fine Need Aspiration System (19GA); Material/Part #: DSN-19-01
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic
Matched: Brand — Handle may break during use.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 8, 2017
Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software Application Card,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Medtronic Neuromodulation
Matched: Brand · Product · Product details · Reason for recall — Medtronic is following up to a May 2013 communication regarding the Priming Bolus function for the SynchroMed Infusion System. Medtronic is updating…
FDA (openFDA device enforcement)
Reported Mar 8, 2017
Abdominoplasty Pack, Part numbers AMS3326(B, AMS4381, and AMS4381(B.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Windstone Medical Packaging, Inc.
Matched: Reason for recall — The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits…
123 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 8, 2017
Intact Disposable Wands (part of the Intact System) 777-110: 5 Pack 10mm Disposable Product Usage: The Intact Medical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Medtronic Advanced Energy, LLC
Matched: Brand — Product sterility compromised due to breach of sterile barrier
10 more products in this recall
FDA (openFDA device enforcement)
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