Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,105 results found for implant Page 63 of 125
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class II Terminated
Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D153VRC Product Usage: The implantable cardioverter defibrillat...
Reason: Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing therapy in EnTrust and Escudo implantable cardioverter defibrillators (ICDs) as they ...
Z-2418-2018 July 18, 2018 Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class II Terminated
Percepta CRT-P MRI SureScan, REF W1TR04 Product Usage: The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the pati...
Reason: Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI SureScan due to a timing interaction between the EffectivCRT Diagnostic and the Ven...
Z-2414-2018 July 18, 2018 Mounds View, MN
Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
Class II Terminated
Medtronic EnTrust SingleChamber Implantable Cardioverter Defibrillator with Atrial and Ventricular Therapies and RapidRead Telemetry, D154VRC Product Usage: The implantable cardioverter defibrillat...
Reason: Medtronic has become aware of a potential for loss of high voltage and anti-tachycardia pacing therapy in EnTrust and Escudo implantable cardioverter defibrillators (ICDs) as they ...
Z-2419-2018 July 18, 2018 Mounds View, MN
Zimmer Biomet, Inc.
Class II Terminated
Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 9; 00-7713-009-00
Reason: M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be ob...
Z-2375-2018 July 11, 2018 Warsaw, IN
FHC, Inc.
Class II Terminated
microTargeting" Drive System, Product Number 66-ZD-MD-01
Reason: The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short ...
Z-2348-2018 July 11, 2018 Bowdoin, ME
FHC, Inc.
Class II Terminated
microtargeting" Depth Stop Adapter, Product Model Number, Product Number 66-AC-DS(1.8),
Reason: The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short ...
Z-2359-2018 July 11, 2018 Bowdoin, ME
FHC, Inc.
Class II Terminated
microTargeting" STar" Drive System (Motorized), Product Number ST-DS-ME
Reason: The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short ...
Z-2350-2018 July 11, 2018 Bowdoin, ME
Zimmer Biomet, Inc.
Class II Terminated
Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 11; 00-7713-011-00
Reason: M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be ob...
Z-2366-2018 July 11, 2018 Warsaw, IN
FHC, Inc.
Class II Terminated
microTargeting" Drive System, Product Number MT-DS-01
Reason: The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short ...
Z-2346-2018 July 11, 2018 Bowdoin, ME
FHC, Inc.
Class II Terminated
microTargeting" STar" Drive System (Manual) Distributed by Medtronic, Product Number FC8001
Reason: The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short ...
Z-2357-2018 July 11, 2018 Bowdoin, ME
St Jude Medical Inc.
Class II Terminated
Merlin PCS Programmer Software: 3330 The Merlin PCS programmer (model 3650) is a portable, external device used to support the implanted device, and for this recall the software that resides on the...
Reason: The firm is advising physicians that exposure to sub-freezing temperatures during the supply chain process caused a transient battery voltage drop for a small number of Confirm Rx ...
Z-2335-2018 July 11, 2018 Sylmar, CA
Zimmer Biomet, Inc.
Class II Terminated
Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 17.5; 00-7713-017-00
Reason: M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be ob...
Z-2371-2018 July 11, 2018 Warsaw, IN
FHC, Inc.
Class II Terminated
microTargeting" Lead Adapter for microTargeting" Drive, Product Number 66-CN-DB
Reason: The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short ...
Z-2353-2018 July 11, 2018 Bowdoin, ME
FHC, Inc.
Class II Terminated
microTargeting" STar" Drive System (Manual), Product Number 70-ZD-MA
Reason: The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short ...
Z-2351-2018 July 11, 2018 Bowdoin, ME
FHC, Inc.
Class II Terminated
microTargeting" Drive System, Product Number MT-DS
Reason: The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short ...
Z-2345-2018 July 11, 2018 Bowdoin, ME
FHC, Inc.
Class II Terminated
microTargeting" Drive System Distributed by Medtronic, Product Number 9033G0601
Reason: The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short ...
Z-2356-2018 July 11, 2018 Bowdoin, ME
Zimmer Biomet, Inc.
Class II Terminated
Zimmer¿ M/L Taper Hip Prosthesis With Kinectiv¿ Technology Cementless, Size 5; 00-7713-005-00
Reason: M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be ob...
Z-2363-2018 July 11, 2018 Warsaw, IN
Implant Direct Sybron Manufacturing, LLC
Class II Terminated
REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60
Reason: Due to out of specification, the clinician would not be able to fit and engage the abutment with the implant
Z-2376-2018 July 11, 2018 Thousand Oaks, CA
Zimmer Biomet, Inc.
Class II Terminated
Zimmer¿ M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Standard Offset; 00-7711-004-10
Reason: M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be ob...
Z-2362-2018 July 11, 2018 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 16.25; 00-7713-016-00
Reason: M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be ob...
Z-2370-2018 July 11, 2018 Warsaw, IN
Zimmer Biomet, Inc.
Class II Terminated
Zimmer M/L Taper Hip Prosthesis Plasma Sprayed, Size 4 Extended Offset, 00-7711-004-40
Reason: M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be ob...
Z-2361-2018 July 11, 2018 Warsaw, IN
FHC, Inc.
Class II Terminated
microTargeting" STar" Drive System (Manual), Product Number ST-DS-MA
Reason: The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short ...
Z-2349-2018 July 11, 2018 Bowdoin, ME
FHC, Inc.
Class II Terminated
microTargeting" STar" Drive System (Motorized), Product Number 70-ZD-ME
Reason: The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short ...
Z-2352-2018 July 11, 2018 Bowdoin, ME
FHC, Inc.
Class II Terminated
microTargeting" Drive System, Product Number 66-ZD-MD
Reason: The FHC Depth Stop Adapter may cause damage to the lead and stylet when the depth stop screw is over-tightened onto the lead. This damage can manifest as low impedances or a short ...
Z-2347-2018 July 11, 2018 Bowdoin, ME
Zimmer Biomet, Inc.
Class II Terminated
Zimmer¿ M/L Taper Hip Prosthesis With Kinective¿ Technology Cementless, Size 13.5; 00-7713-013-00
Reason: M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be ob...
Z-2368-2018 July 11, 2018 Warsaw, IN