Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 90 of 138
Biosense Webster, Inc.
Class II Terminated
THERMOCOOL SMARTTOUCH SF Bi-Directional Product Codes D-1348-01-S, D-1348-04-S, D-1348-05-S
Reason: Biosense Webster, Inc. has recently received an increased number of complaints related to the display of Alert 402 on the CARTO 3 System for certain lots of THERMOCOOL brand cathet...
Z-0055-2018 November 8, 2017 Irwindale, CA
OriGen Biomedical, Inc.
Class I Terminated
The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat...
Reason: Two users have reported to OriGen that a VV28F OriGen Reinforced Dual Lumen ECMO Catheter has had a separation of the clear extension tube from the hub connection. These adverse ...
Z-0021-2018 November 1, 2017 Austin, TX
Spectranetics Corporation
Class I Terminated
Spectranetics Bridge Occlusion Balloon catheter, Sheath Compatibility 12F, Guidewire Compatibility 0.035in, Working Length 90cm, Balloon Outer Diameter 31mm, Balloon Length 80mm, Rx Only. Product U...
Reason: Possible inability to pass the guidewire through the Bridge device, therefore, resulting in a potential delay of treatment.
Z-3106-2017 October 4, 2017 Colorado Springs, CO
Medtronic Vascular, Inc.
Class II Terminated
Medtronic Aptus Heli-FX Thoracic EndoAnchor System Heli-FX Guide 42 mm, REF HG-18-90-42, STERILE EO, Rx Only The Heli-FX EndoAnchor System is intended to provide fixation and sealing between endov...
Reason: It was determined that the deflection length indicated on the Guide catheter handle does not match the label on the box and sterile packaging for two lots.
Z-3227-2017 October 4, 2017 Santa Rosa, CA
C.R. Bard, Inc.
Class II Terminated
Bard Magic 3 Antibacterial Hydrophilic Intermittent Catheter Female, 14 FR (30/box), Rx Only intended for urinary bladder drainage in patients requiring catheterization for management of incontinence,...
Reason: Specific lots labeled as an Antibacterial Hydrophilic Intermittent Catheter may lack the hydrophilic coating.
Z-3226-2017 October 4, 2017 Covington, GA
Medtronic Vascular Galway DBA Medtronic Ireland
Class II Terminated
Euphora Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.
Reason: Stylette removal difficulties on the Euphora and Solarice products.
Z-3136-2017 September 27, 2017 Galway, N/A
Medtronic Vascular Galway DBA Medtronic Ireland
Class II Terminated
Solarice Rapid Exchange Balloon Dilatation Catheter, a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System.
Reason: Stylette removal difficulties on the Euphora and Solarice products.
Z-3137-2017 September 27, 2017 Galway, N/A
Edwards Lifesciences, LLC
Class II Terminated
Fogarty Adherent Clot Catheter Model Numbers 1408010 and 140806 Product Usage: The Fogarty adherent clot catheters are designed to effectively remove clot material in the peripheral vasculature. T...
Reason: The diameter of the Fogarty Catheter balloon, measures 6mm instead of 10mm.
Z-3077-2017 September 6, 2017 Irvine, CA
Medspira, Llc
Class II Terminated
mcompass 2-channel Balloon Catheters The mcompass Biofeedback Anorectal Manometry System is for use on patients requiring anorectal pressure studies. mcompass Anorectal Manometry System (RMD-001-00...
Reason: Potential failure in the balloon bond in the inner catheter stem, leading to the separation of the balloon from the inner stem, leaving it in the rectal cavity.
Z-3072-2017 September 6, 2017 Minneapolis, MN
CareFusion 303, Inc.
Class II Terminated
VersaSafe Plastic Cannula - 11 Gauge, Model 9391-0200 Product Usage: Used with secondary IV sets or syringes with a female luer lock adapter to administer fluid and medications through a needle or...
Reason: Punctures in blister packaging that was detected during the packaging process.
Z-3030-2017 August 23, 2017 San Diego, CA
C.R. Bard, Inc.
Class II Terminated
BARD DISPOZ-A-BAG Leg Bag with Flip-Flo Valve with Drain Extension, Extension Tube and Latex Straps, 19 oz. Packaged as single unit in thermoformed trays. There are 50 units per case. Product Usa...
Reason: Customer complaint of a cut in the side of the leg bag, indicating a potential breach of the product's sterile barrier.
Z-2872-2017 August 16, 2017 Covington, GA
Myelotec, Inc.
Class II Ongoing
Myelotec Video Guided Catheters, REF 2010 3.0 mm OD x 30 Cm Working Length, Two 1.3mm Working Channels
Reason: Obstructed/blocked port from defective VGC Access Port Body component.
Z-2779-2017 August 9, 2017 Roswell, GA
Stryker Neurovascular
Class II Terminated
Stroke Fast Pack(TM) Trevo XP ProVue Retriever 6 x 25, AXS Catalyst 060x132CM - US, EXCELSIOR XT 27 MICROCATHETER, UPN M0033PK62523001 ST 150
Reason: Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs were manufactured using a carton sleeve where the pre-printed contents on the back of the sleeve did not ...
Z-2802-2017 August 9, 2017 Fremont, CA
Stryker Neurovascular
Class II Terminated
Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 20, Trevo Pro 18 Microcatheter, AXS Catalyst 060x132CM - US, UPN M0033PK42022001
Reason: Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs were manufactured using a carton sleeve where the pre-printed contents on the back of the sleeve did not ...
Z-2800-2017 August 9, 2017 Fremont, CA
Spectranetics Corporation
Class II Terminated
Spectranetics Turbo-Elite Laser Atherectomy Catheter Peripheral Rapid Exchange Catheters Device is indicated for use in the treatment, including atherectomy, of infrainguinal stenosis and occlusions
Reason: Potential for flouroscopially visible marker band at the tip of the Rapid Exchange Turbo Elite Atherectomy Catheters to become loose or disengaged rom the catheter when the device ...
Z-2863-2017 August 9, 2017 Colorado Springs, CO
Stryker Neurovascular
Class II Terminated
Stroke Fast Pack(TM) Trevo XP ProVue Retriever 4 x 30, Trevo Pro 18 Microcatheter, AXS Catalyst 060x132CM - US, UPN M0033PK43022001
Reason: Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs were manufactured using a carton sleeve where the pre-printed contents on the back of the sleeve did not ...
Z-2801-2017 August 9, 2017 Fremont, CA
Greatbatch Medical
Class II Terminated
Biosense Webster MobiCath Bi-Directional Guiding Sheath, Model D140010 (small curve) and D140011 (large curve). The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter...
Reason: One side of the MobiCath Bi-Directional Guiding Sheath pouch may not be sealed.
Z-2782-2017 August 9, 2017 Plymouth, MN
Stryker Neurovascular
Class II Terminated
Stroke Fast Pack(TM) Trevo XP ProVue Retriever 3 x 20, Trevo Pro 14 Microcatheter, AXS Catalyst 060x132CM - US, UPN M0033PK32021001
Reason: Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs were manufactured using a carton sleeve where the pre-printed contents on the back of the sleeve did not ...
Z-2799-2017 August 9, 2017 Fremont, CA
Medtronic Navigation, Inc.
Class II Terminated
Medtronic Visualase(R) Cooled Laser Applicator System (VCLAS) 15MM TIP, REF 9735561, (1) Laser Diffusing Fiber - 600um Core, 15mm Tip, (1) Cooling Catheter with 3M(TM) SteriStrip(TM), (1) Pump Tubing ...
Reason: 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 the optical fiber to ensure adeq...
Z-2755-2017 August 2, 2017 Louisville, CO
Atrium Medical Corporation
Class II Terminated
Atrium iCAST Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/Part Number 85455 (Marketed in U.S. only) Atrium Advanta V12 Balloon Expandable Covered Stent; 7mm x 22mm x 120cm; Model/P...
Reason: Firm received a complaint that a customer who ordered an ADVANTA V12 7mm x 22mm x 120cm received an ADVANTA v12 7 mm x 38 mm x 80 cm, due to the manifold (catheter hub) was printed...
Z-2761-2017 August 2, 2017 Hudson, NH
Flowonix Medical, Inc.
Class II Terminated
PROMETRA II Programmable Infusion Pump, Implantable Infusion Pump, Catalog Number/REF 13827, Part Number PL-31790-02. Manufactured by: Flowonix Medical Inc., --- The correction involves the labeling...
Reason: Flowonix Medical received a report of a patient implanted with the Prometra II Programmable Pump who may have received a fatal drug overdose during an MRI procedure. The Prometra I...
Z-2740-2017 July 26, 2017 Mount Olive, NJ
ICU Medical, Inc.
Class II Terminated
18 cm (7") PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, NanoClave¿, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides ac...
Reason: The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
Z-2716-2017 July 19, 2017 San Clemente, CA
ICU Medical, Inc.
Class II Terminated
28 cm (11") PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, NanoClave¿, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides ac...
Reason: The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
Z-2719-2017 July 19, 2017 San Clemente, CA
Arrow International Inc
Class II Terminated
Arrow EVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology
Reason: Arrow is recalling additional lots that were identified as part of an active recall. Arrow is recalling the affected product due to the possibility that the catheter peel-away comp...
Z-2698-2017 July 19, 2017 Reading, PA
ICU Medical, Inc.
Class II Terminated
28 cm (11") PUR Bifuse Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, 2 NanoClave¿, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides acc...
Reason: The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
Z-2718-2017 July 19, 2017 San Clemente, CA