Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 120 of 138
Covidien LLC
Class II Terminated
Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code:8888145064
Reason: Catheters may not meet antimicrobial specification
Z-1862-2015 July 8, 2015 North Haven, CT
Covidien LLC
Class II Terminated
Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128458P
Reason: Catheters may not meet antimicrobial specification
Z-1886-2015 July 8, 2015 North Haven, CT
Covidien LLC
Class II Terminated
Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050P
Reason: Catheters may not meet antimicrobial specification
Z-1902-2015 July 8, 2015 North Haven, CT
Covidien LLC
Class II Terminated
Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145065
Reason: Catheters may not meet antimicrobial specification
Z-1864-2015 July 8, 2015 North Haven, CT
Covidien LLC
Class II Terminated
Palindrome SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066
Reason: Catheters may not meet antimicrobial specification
Z-1866-2015 July 8, 2015 North Haven, CT
Covidien LLC
Class II Terminated
Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 23cm Item Code: 8888145048P
Reason: Catheters may not meet antimicrobial specification
Z-1898-2015 July 8, 2015 North Haven, CT
Covidien LLC
Class II Terminated
Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 19cm Item Code: 8888119369P
Reason: Catheters may not meet antimicrobial specification
Z-1908-2015 July 8, 2015 North Haven, CT
Covidien LLC
Class II Terminated
Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050
Reason: Catheters may not meet antimicrobial specification
Z-1894-2015 July 8, 2015 North Haven, CT
Covidien LLC
Class II Terminated
Palindrome SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888145064C
Reason: Catheters may not meet antimicrobial specification
Z-1863-2015 July 8, 2015 North Haven, CT
Covidien LLC
Class II Terminated
Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888145050C
Reason: Catheters may not meet antimicrobial specification
Z-1896-2015 July 8, 2015 North Haven, CT
Covidien LLC
Class II Terminated
Palindrome HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr x 28cm Item Code:8888145049C
Reason: Catheters may not meet antimicrobial specification
Z-1893-2015 July 8, 2015 North Haven, CT
Covidien LLC
Class II Terminated
Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066CP
Reason: Catheters may not meet antimicrobial specification
Z-1879-2015 July 8, 2015 North Haven, CT
Covidien LLC
Class II Terminated
Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 33cm Item Code: 8888133509P
Reason: Catheters may not meet antimicrobial specification
Z-1911-2015 July 8, 2015 North Haven, CT
Covidien LLC
Class II Terminated
Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 44cm Item Code: 8888146144CP
Reason: Catheters may not meet antimicrobial specification
Z-1877-2015 July 8, 2015 North Haven, CT
Covidien LLC
Class II Terminated
Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064
Reason: Catheters may not meet antimicrobial specification
Z-1854-2015 July 8, 2015 North Haven, CT
Covidien LLC
Class II Terminated
Palindrome Precision SI Chronic Catheter Kit 14.5 Fr x 55cm Item Code: 8888145066CP
Reason: Catheters may not meet antimicrobial specification
Z-1880-2015 July 8, 2015 North Haven, CT
Covidien LLC
Class II Terminated
Palindrome SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5 Fr x 28cm Item Code: 8888128458
Reason: Catheters may not meet antimicrobial specification
Z-1882-2015 July 8, 2015 North Haven, CT
Volcano Corporation
Class II Terminated
Volcano PV .035 Catheter: Part number: 88901; Product Usage: The Volcano PV .035 is indicated for use in the evaluation of vascular morphology in blood vessels of the peripheral vasculature by pr...
Reason: During a relabeling procedure at the manufacturing facility, the products were labeled with a shelf life in accordance with the date of the relabeling and not in accordance with th...
Z-1844-2015 July 1, 2015 Rancho Cordova, CA
Integra LifeSciences Corp.
Class II Terminated
Integra Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt Fitting, Catalog No. 110-4L The Camino Intracranial Pressure Monitoring Catheter is a sterile transducer-tipped pressure m...
Reason: Integra LifeSciences is recalling the Camino Intracranial Pressure Monitoring Catheters because they may have been incorrectly assembled. Specifically, the o-ring in the bolt adap...
Z-1815-2015 June 24, 2015 Plainsboro, NJ
Acclarent, Inc.
Class III Terminated
RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product Usage - Sinus Catheter - Intended to provide a means to access the sinus space for diagnostic and therapeutic procedures. .
Reason: Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it's expiry date.
Z-1740-2015 June 17, 2015 Menlo Park, CA
Edwards Lifesciences, LLC
Class II Terminated
Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75. Flow-directed pulmonary artery catheters for monitoring cardiac output, mixed venous oxygen saturation, and end diastolic vo...
Reason: The product failed to meet the internal established statistical test requirement for heparin activity.
Z-1700-2015 June 10, 2015 Irvine, CA
Medtronic Neuromodulation
Class II Terminated
Medtronic SynchroMed II Implantable Infusion Pumps, models 8637-20 and 8637-40. Sterile. Product Usage: The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system t...
Reason: Medtronic is conducting a recall of a specific subset of Model 8637-20 and 8637-40 SynchroMed II implantable drug pumps because the audible alarm could cease to function.
Z-1681-2015 June 3, 2015 Minneapolis, MN
Biosense Webster, Inc.
Class II Terminated
SMARTABLATE RF Generator System, Catalog No. M490006, M490007, M4900106, and M4900107. Product Usage: The use of the SMART ABLATE Generator and all accessories is indicated in combination with com...
Reason: Biosense Webster is recalling the SMARTABLATE Generator System because Biosense Webster has received two complaints reporting that during an RMT procedure the SMARTABLATE RF Genera...
Z-1691-2015 June 3, 2015 Irwindale, CA
Integra LifeSciences Corp.
Class II Terminated
The Integra Licox Pt02 Monitors are compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters. The LCX02R monitor measures and dis...
Reason: Integra LifeSciences Corporation is recalling Integra's Camino ICP Monitor (CAM 02) & Licox PtO2 Monitor ( LCX02 & LCX02R) due to complaints that the audible speaker malfunctions.
Z-1620-2015 May 27, 2015 Plainsboro, NJ
Integra LifeSciences Corp.
Class II Terminated
The Integra Licox Pt02 Monitors are compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters. The LCX02 monitor measures and disp...
Reason: Integra LifeSciences Corporation is recalling Integra's Camino ICP Monitor (CAM 02) & Licox PtO2 Monitor ( LCX02 & LCX02R) due to complaints that the audible speaker malfunctions.
Z-1619-2015 May 27, 2015 Plainsboro, NJ