Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 124 of 138
Customed, Inc
Class I Terminated
Suction Catheter Kit, Catalog number 900-277. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason: Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncont...
Z-0243-2015 December 10, 2014 Fajardo, PR
Customed, Inc
Class I Terminated
Foley Catheter Kit, Catalog number 900-1127. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason: Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncont...
Z-0276-2015 December 10, 2014 Fajardo, PR
Stryker Neurovascular
Class II Terminated
GDC-10 360 10mm x 30cm SR ; GDC 360¿ Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's general me...
Reason: Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.
Z-0479-2015 December 10, 2014 Fremont, CA
Customed, Inc
Class I Terminated
Umbilical Vessel Catheter Kit, Catalog number 900-1408. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Reason: Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncont...
Z-0290-2015 December 10, 2014 Fajardo, PR
Stryker Neurovascular
Class II Terminated
GDC-10 360 SOFT 3mm x 6cm SR ; GDC 360¿ Detachable Coils are intended for embolization of those intracranial aneurysms that- because of their morphology, their location, or the patient 's general...
Reason: Units of GDC 360 coils, Target coil and Gateway PTA Balloon Catheter were shipped to US customers beyond the expiration date.
Z-0478-2015 December 10, 2014 Fremont, CA
ZOLL Circulation, Inc.
Class II Terminated
7F NeuroFlo Catheter, Model 1027 The NeuroFlo Catheter is a multi-lumen device with two balloons mounted near the distal tip for the treatment of cerebral ischemia resulting from symptomatic vasos...
Reason: After aquisition of assets of CoAxia, Zoll discovered that one lot of NeuroFlo Catheters was manufactured by another firm and an HDE supplement listing as the owner of the product...
Z-0477-2015 December 3, 2014 San Jose, CA
Philips Medical Systems (Cleveland) Inc
Class II Terminated
IntelliSpace Portal DX/HX/EX model number: 881001 IntelliSpace Portal DX/HX/EX Upgrade model number: 881011 IntelliSpace Portal DX/HX/EX Demo model number: 881012 IntelliSpace Portal IX model numbe...
Reason: Software defect. In certain circumstances, the application may display incorrect measurements of cardiac and aortic anatomy used to select and size the Transcatheter heart valve (...
Z-0473-2015 December 3, 2014 Cleveland, OH
Edwards Lifesciences, LLC
Class II Terminated
Edwards Lifesciences Vent Catheters, . Packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Model Numbers: E061, E060, PE062, EM012 Atrial Vent Catheters are intended for venting the le...
Reason: Edwards Lifesciences is conducting a field action on the Vent Catheters due to the potential for disruption of the white plastic coating on the stylet.
Z-0217-2015 November 26, 2014 Draper, UT
Medtronic Vascular
Class II Terminated
Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K
Reason: Two reports have been received on the 6F launcher Guide Catheter lot (Model Number LA6JR40K; lot No 0007244836} for incorrect usable length of the Guide Catheter. It was reported t...
Z-0205-2015 November 19, 2014 Danvers, MA
St Jude Medical
Class II Terminated
St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353
Reason: St. Jude Medical is performing a voluntary recall of batch 4671318, model number 401353 of the Response Fixed Curve DECA 6F 65cm CSL 2/8 Catheter. Specifically, the firm has identi...
Z-0177-2015 November 12, 2014 Saint Paul, MN
Trivascular, Inc
Class I Terminated
Ovation Prime Abdominal Stent Graft System - 29mm Aortic Body stent grafts. The TriVascular Ovation Prime Abdominal Stent Graft System is a low-profile endovascular device delivered via catheter to...
Reason: TriVascular has identified select lots of Ovation Prime 29mm Aortic Body stent grafts that may be associated with rapid emptying of the fill polymer syringe when it is connected to...
Z-0125-2015 November 12, 2014 Santa Rosa, CA
Merit Medical Systems, Inc.
Class II Terminated
Merit Maestro Microcatheter, 2.4F 130cm Straight, REF28MC24130ST, Rx Only, Non-pyrogenic Sterile if package is unopened or undamaged.
Reason: These microcatheters were packaged with a 2.8 F distal tip, rather than the labeled 2.4 F.
Z-0162-2015 November 12, 2014 South Jordan, UT
Biosense Webster, Inc.
Class II Terminated
ThermoCool SmartTouch Navigation Catheters, Catalog No. D132701, D132702, D132703, D132704, D132705, D133601, D133602, D133603.
Reason: The recall was initiated because Biosense Webster is providing additional labeling for the safe and effective use of the ThermoCool SmartTouch Catheter.
Z-0139-2015 November 5, 2014 Irwindale, CA
Codman & Shurtleff, Inc.
Class II Terminated
Codman EDS 3 Drainage System (no Ventricular Catheter) (External Drainage System) Catalog Number: 82-1731 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical chara...
Reason: tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or under-drainage of CSF from the ventricular system or introduction of air ...
Z-0090-2015 October 29, 2014 Raynham, MA
Codman & Shurtleff, Inc.
Class II Terminated
Codman Lumbar Drainage Catheter Kit II with EDS 3 (External Drainage System) Catalog Number: 82-1738 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteri...
Reason: tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or under-drainage of CSF from the ventricular system or introduction of air ...
Z-0091-2015 October 29, 2014 Raynham, MA
Arrow International Inc
Class II Terminated
ASK-05501-AFH1, Lot Number 23F13K0969 Anesthesia Conduction Catheter, Epidural Anesthesia Kit
Reason: Arrow International, Inc. is notifying customers that lot 23F13K0969 of product code ASK-05501-AFH1 contains an incorrect component. The lidstock indicates that the kit contains on...
Z-0114-2015 October 29, 2014 Reading, PA
Vygon Corporation
Class II Terminated
Bionector Needleless connector. Bionector is a multi-purpose catheter accessory; a closed needle-less system permitting blood sampling, intermit ant injection and continuous infusion of fluids or medi...
Reason: Vygon has uncovered potential problems with membrane elasticity in the 896.038, Bionector Needleless connector and is issuing a voluntary recall of the 896.038, Bionector Needleles...
Z-0113-2015 October 29, 2014 Lansdale, PA
Codman & Shurtleff, Inc.
Class II Terminated
Codman EDS 3 Drainage System with Ventricular Catheter (External Drainage System) Catalog Number: 82-1730 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical charac...
Reason: tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or under-drainage of CSF from the ventricular system or introduction of air ...
Z-0089-2015 October 29, 2014 Raynham, MA
Arrow International Inc
Class II Terminated
Multi-Lumen Central Venous Catheterization Kit
Reason: Arrow International, Inc. has initiated a voluntary recall for product code AK- 12703, lot number RF3039028 because the label on the outer corrugate is labeled with the incorrect ...
Z-0076-2015 October 22, 2014 Reading, PA
STERILMED, INC.
Class II Terminated
Biosense Webster's Reprocessed SOUNDSTAR¿ eco Diagnostic Ultrasound Catheters, Catalog Nos: M-5723-115, Model Number BIO10438577.
Reason: Sterilmed, a division of Johnson & Johnson Medical NV/SA (Sterilmed), has become aware of an issue affecting certain lots of Reprocessed SOUNDSTAR® eco Diagnostic Ultrasoun...
Z-0059-2015 October 15, 2014 Maple Grove, MN
Argon Medical Devices, Inc
Class II Terminated
UltraStream Peel Away Kit; Model Numbers 32401524 (24 cm), 32401528 (28cm), 32401532 (32 cm), and 32401536 (36 cm) and 32402540 (40 cm) The Rex Medical UltraStream Chronic Hemodialysis Catheter is ...
Reason: UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation.
Z-2698-2014 October 1, 2014 Athens, TX
Argon Medical Devices, Inc
Class II Terminated
UltraStream Chronic Hemodialysis Catheter Standard Kit; Model Number 32101524 (24 cm), 32101528 (28cm), 32101532 (32 cm), and 32101536 (36 cm) and 32102540 (40 cm). The Rex Medical UltraStream Chronic...
Reason: UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation.
Z-2696-2014 October 1, 2014 Athens, TX
Argon Medical Devices, Inc
Class II Terminated
UltraStream Exchange Kit Model Numbers 32001524 (24 cm), 32001528 (28cm), 32001532 (32 cm), and 32001536 (36 cm) and 32002540 (40 cm). The Rex Medical UltraStream Chronic Hemodialysis Catheter is a c...
Reason: UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation.
Z-2697-2014 October 1, 2014 Athens, TX
Teleflex Medical
Class II Terminated
Rusch, Soft Rubber (Nelaton and Nelaton Robinson), Bladder Catheter, Sterile. These catheters are indicated for the routine drainage of urine from the bladder. These catheters are not intended or d...
Reason: Misbranding: Although the product labeling identifies the catheters as "soft rubber," the Natural Rubber Latex caution statement was not printed on the product label.
Z-2661-2014 September 24, 2014 Research Triangle Park, NC
Volcano Corporation
Class II Terminated
Volcano TrakBack II Disposable Pullback Device; Sterile and nonpyrogenic; Single Use. TrakBack II is used to move the catheter steadily and precisely, allowing uniform collection of imaging data.
Reason: Internal testing had identified a potential breach to the sterile barrier that may impact the sterility of the product.
Z-2636-2014 September 24, 2014 Rancho Cordova, CA