Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 122 of 138
Biosense Webster, Inc.
Class II Terminated
LASSO NAV Duo Loop eco Catheters, Catalog No. D-1354-01, D-1354-02, D-1354-03, D-1354-04, D-1354-05, D-1354-06. LASSO NAV DUO LOOP eco Catheter is indicated for multiple electrode electrophysiologica...
Reason: Biosense Webster is recalling the LASSO NAV Duo Loop eco Catheters because of reports of difficulty retracting and damage to the spine cover.
Z-1242-2015 March 11, 2015 Irwindale, CA
Boston Scientific Corp
Class I Terminated
IntellaTip MiFi Open-Irrigated radiofrequency Ablation Catheters: Material number: M004EPM96200, Catalog Number: EPM9620: Material number: M004EPM9620K20, Catalog Number: EPM9620K2; Material number...
Reason: Reports of formation of char adherent to the proximal part of the distal tip electrodes
Z-1209-2015 March 11, 2015 San Jose, CA
Arrow International Inc
Class II Terminated
ARROW Epidural Needle Component (product number AN-05501). Epidural needles permit access to the epidural space and are used as a conduit for epidural catheter placement.
Reason: The product labeling does not specify the 5 year shelf life of the product.
Z-1080-2015 February 18, 2015 Reading, PA
Medical Components, Inc dba MedComp
Class II Terminated
Hemodialysis Catheters and PICCs: Product identification: MCDLTSL24P (SF X 24CM LT HEMO-CATH), MC061422 (14FX15CM SLX DBL LMN ST CATH), MRCTP41017 (4F X 55CM SINGLE CT PICC), MRCTP52007 (5F DUAL PR...
Reason: Drug products contained within the kits may have been rendered ineffective by a duplicate sterilization process. The kits include one or more of the following drugs: 5ml ampule ...
Z-1083-2015 February 18, 2015 Harleysville, PA
Arrow International Inc
Class II Terminated
ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit. The Multiple-Lumen Catheter permits venous access to the central circulation by way of the femoral jugular, or subclavian veins.
Reason: Foreign material found within the kits. The foreign material, white or black particles and/or thread, is visible and can beidentified by the user.
Z-1082-2015 February 18, 2015 Reading, PA
CareFusion 303, Inc.
Class II Terminated
SmartSite Low Sorbing Infusion Set, Model No. 10015862 The SmartSite Infusion Sets are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein...
Reason: CareFusion is recalling the SmartSite Low Sorbing Infusion set due to disconnection and leakage issues.
Z-1053-2015 February 11, 2015 San Diego, CA
Arrow International Inc
Class III Terminated
Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch Dressing
Reason: Certain product codes and lot numbers of Kits with Biopatch Dressing were packaged with the incorrect size Biopatch Dressing. No risk to patients is anticipated.
Z-1030-2015 February 4, 2015 Reading, PA
Clinical Innovations, LLC
Class II Terminated
Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO
Reason: Potential for a balloon leak in all lots of (CTS-1000) manufactured since August 2014.
Z-1014-2015 February 4, 2015 Murray, UT
Arrow International Inc
Class II Terminated
The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and NextStep Antegrade Hemodialysis Catheterization Set, Long-Term Access, part numbers: AC-15192-SFX, AC-15232-SFX, AC-15272-SFX, AC-1...
Reason: The tunneling sheath packaged within the kits can crack during placement. If the tunneling sheath cracks, it can cause a delay in treatment for the time it takes to retrieve a rep...
Z-1007-2015 January 28, 2015 Reading, PA
Cordis Corporation
Class II Terminated
Cordis POWERFLEX PRO PTA Dilatation Catheter Intended to dilate stenoses in iliac, femoral, ilio-femoral, popliteal, infra popliteal and renal arteries and for the treatment of obstructive lesions ...
Reason: One unit from a demo lot of POWERFLEX PRO PTA Dilatation Catheter was left at a hospital and was not sterilized.
Z-0998-2015 January 28, 2015 Miami Lakes, FL
Arrow International Inc
Class II Terminated
Multi-Lumen PI CVC Kit and PSI Kit: 3-L 7 FR X 8 product code: ASK-45703-POSU lot #23F13L0166, exp. 31-Jul-2015: Product Usage: Multi-Lumen PI CVC Kit: An intravascular catheter is a device tha...
Reason: the Instructions for Use (IFU) were inadvertently removed from the kit.
Z-1005-2015 January 28, 2015 Reading, PA
Boston Scientific Corporation
Class I Terminated
Lotus TAVR 27mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Material number H749LTV270, Catalog Number LTV27; Product Usage: The Lotus Valve System is intended t...
Reason: Lotus valve became unlocked during release from the delivery system. This may lead to percutaneous insertion of another valve, resulting in a Valve in Valve (ViV) implantation. If...
Z-0917-2015 January 21, 2015 Los Gatos, CA
Boston Scientific Corporation
Class I Terminated
Lotus TAVR 25mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Material number H749LTV250, Catalog Number LTV25; Product Usage: The Lotus Valve System is intended t...
Reason: Lotus valve became unlocked during release from the delivery system. This may lead to percutaneous insertion of another valve, resulting in a Valve in Valve (ViV) implantation. If...
Z-0916-2015 January 21, 2015 Los Gatos, CA
Boston Scientific Corporation
Class I Terminated
Lotus TAVR 23mm, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System; Sterile Material number H749LTV230, Catalog Number LTV23; Product Usage: The Lotus Valve System is intended ...
Reason: Lotus valve became unlocked during release from the delivery system. This may lead to percutaneous insertion of another valve, resulting in a Valve in Valve (ViV) implantation. If...
Z-0915-2015 January 21, 2015 Los Gatos, CA
Roche Diagnostics Operations, Inc.
Class II Terminated
ACCU-CHEK Tender II 13/60 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted in...
Reason: Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion se...
Z-0889-2015 January 7, 2015 Indianapolis, IN
Roche Diagnostics Operations, Inc.
Class II Terminated
ACCU-CHEK Tender I 17/60 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independ...
Reason: Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion se...
Z-0886-2015 January 7, 2015 Indianapolis, IN
PEROUSE MEDICAL
Class II Terminated
Synthes Inflation System (03.804.4135) Product Usage: Inflation system is used during kyphoplasty or other interventional kyphoplasty or other interventional procedures, to create and monitor pre...
Reason: Additional instructions for use due to inability to raise the pressure above 10 atm during inflation phase may result in an incomplete inflation or delay in procedure
Z-0877-2015 January 7, 2015 Ivry Le Temple, N/A
Roche Diagnostics Operations, Inc.
Class II Terminated
ACCU-CHEK Tender I 13/80 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independ...
Reason: Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion se...
Z-0884-2015 January 7, 2015 Indianapolis, IN
PEROUSE MEDICAL
Class II Terminated
Bard Caliber (CL3030) Inflation Device Product Usage: Inflation Device intended for use during cardiovascular to create and maintain, monitor pressure in the balloon catheter - balloon inflation...
Reason: Additional instructions for use due to inability to raise the pressure above 10 atm during inflation phase may result in an incomplete inflation or delay in procedure
Z-0876-2015 January 7, 2015 Ivry Le Temple, N/A
Roche Diagnostics Operations, Inc.
Class II Terminated
ACCU-CHEK Tender II 17/110 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted i...
Reason: Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion se...
Z-0894-2015 January 7, 2015 Indianapolis, IN
Roche Diagnostics Operations, Inc.
Class II Terminated
ACCU-CHEK Tender II 17/60 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted in...
Reason: Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion se...
Z-0892-2015 January 7, 2015 Indianapolis, IN
Roche Diagnostics Operations, Inc.
Class II Terminated
ACCU-CHEK Tender I 13/110 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted indepen...
Reason: Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion se...
Z-0885-2015 January 7, 2015 Indianapolis, IN
Roche Diagnostics Operations, Inc.
Class II Terminated
ACCU-CHEK¿ Tender I 13/60 10 pieces Product Usage: Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserte...
Reason: Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion se...
Z-0883-2015 January 7, 2015 Indianapolis, IN
Roche Diagnostics Operations, Inc.
Class II Terminated
ACCU-CHEK Tender II 17/80 10 + 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted in...
Reason: Roche Diabetes Care was informed by UnoMedical, the Manufacturer of ACCU-CHEK Tender I and ACCU-CHEK Tender II infusion sets, about potential for the the tubing of the infusion se...
Z-0893-2015 January 7, 2015 Indianapolis, IN
Hansen Medical Inc
Class II Terminated
Sensei X Robotic Catheter System, model numbers 02057 and 08257. - Set up joint (SUJ)mechanical clamp that secures the SUJ to the catheter laboratory table. Product Usage: The Sensei X Robotic ...
Reason: The Set Up Joint subassembly of the Sensei X Robotic Catheter System may become loose relative to the operating table with the potential for the device to fall causing, uncontrolle...
Z-0896-2015 January 7, 2015 Mountain View, CA