Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 121 of 138
Integra LifeSciences Corp.
Class II Terminated
The Integra Camino ICP Monitor is a compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters. The CAM02 monitor measures and disp...
Reason: Integra LifeSciences Corporation is recalling Integra's Camino ICP Monitor (CAM02) & Licox PtO2 Monitor ( LCX02 & LCX02R) due to complaints that the audible speaker malfunctions.
Z-1618-2015 May 27, 2015 Plainsboro, NJ
Biosense Webster, Inc.
Class II Terminated
WEBSTER HIS Catheter, 4 Pole Fixed Curve with Auto ID Technology, for mapping of cardiac structure; i.e., stimulation and recording only. Catalog No: 01085413
Reason: The Webster HIS catheter, 4Pole Fixed Curve with Auto ID, is not being recognized by the CARTO 3 navigation System.
Z-1525-2015 May 6, 2015 Irwindale, CA
Medical Components, Inc dba MedComp
Class II Terminated
9F Plastic Dual Port; The port systems are totally implantable vascular access devices. They consist of an injection port, a self-sealing membrane and a detachable catheter. The port systems provide r...
Reason: The dual port with catheters was not covered under FDA clearance.
Z-1527-2015 May 6, 2015 Harleysville, PA
OriGen Biomedical, Inc.
Class I Terminated
OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO NOT RE-USE Manufactured by: OriGen Biomedical. OriGene VV13F Reinforced Dual Lumen Catheter indicated for use as a s...
Reason: Potential for clear extension tube to separate from the hub, which could result in blood loss and may require intervention to prevent permanent impairment/damage.
Z-1456-2015 April 29, 2015 Austin, TX
Catheter Research, Inc
Class II Terminated
HSG Trays/HS 5F Catheter Combo; HSG Procedure Tray+ Shapeable 5F HSG catheter. For hysterosonography and hysterosalpingography, gynecological use.
Reason: HSG Trays and Catheters were mislabeled. Trays with the flexible HS catheter were labeled as containing the shapeable, stiffer HS catheter, and vice versa.
Z-1481-2015 April 29, 2015 Indianapolis, IN
Bard Peripheral Vascular Inc
Class II Terminated
Bard ConQuest PTA Balloon Dilatation Catheter, 12mm Balloon Size, Product Code: CQ-75124.
Reason: Bard Peripheral Vascular is recalling the Bard ConQuest PTA Balloon Dilatation Catheter because it may be at risk of having deflation related issues.
Z-1413-2015 April 22, 2015 Tempe, AZ
Bard Access Systems
Class II Terminated
Bard Peripherally Inserted Central Catheter (PICC) and Dialysis catheter kits containing Safe-Cut Safety Scalpels.
Reason: Potential for inadvertent scalpel stick injury involving the safety scalpel.
Z-1443-2015 April 22, 2015 Salt Lake City, UT
Baylis Medical Corp *
Class II Terminated
ProTrack Microcatheter; Product Usage: The ProTrack Microcatheter is a sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires...
Reason: Baylis Medical Company is recalling two lots of ProTrack Microcatheter due to the possibility that the catheter may have circumferential defects along its shaft.
Z-1442-2015 April 22, 2015 Montreal, N/A
Hansen Medical Inc
Class II Terminated
Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites.
Reason: Based on investigation of two complaint incidents, all Hansen Medical Magellan Robotic System (Model No. 11132 and 11139) may experience an unexpected event during a retraction ope...
Z-1449-2015 April 22, 2015 Mountain View, CA
Toshiba American Medical Systems Inc
Class II Terminated
INFX-8000V Interventional Angiography System. CAT-880B catheterization table. Cardiac and Vascular intervention with fluoroscopic and fluorographic images. For the USA and Canada the system is reg...
Reason: The table base rotational brake that holds the table top may not always be engaged when any force or side impact is applied to the table top.
Z-1394-2015 April 15, 2015 Tustin, CA
VasoNova, Inc.
Class II Terminated
VasoNova Vascular Positioning System (VPS ) G4 Console Catalog number VPS-G4C Cardiovascular: The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters...
Reason: A limited number of VPS G4 Consoles are being recalled due to noncompliance with International Electrotechnical Commission Standard 60101-1-1.
Z-1408-2015 April 15, 2015 Menlo Park, CA
Boston Scientific Corporation
Class II Terminated
Boston Scientific: Expel" Drainage Catheter with Twist-Loc" Hub APDL Drainage Catheter and APDL Drainage Catheter Kit, Expel" Drainage Catheter APD Drainage Catheter, Expel" Large Capacity Drainag...
Reason: Boston Scientific is initiating this Medical Device Field Correction of the Expel" APD and APDL Drainage Catheters. To date, Boston Scientific has received one complaint for devic...
Z-1336-2015 April 8, 2015 Maple Grove, MN
Boston Scientific Corporation
Class II Terminated
Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Catheter and Biliary Drainage Catheter Kits
Reason: Complaints of device fragmentation after the catheter was implanted in the biliary system. The most serious patient risk for this issue is additional intervention for fragment retr...
Z-1355-2015 April 8, 2015 Maple Grove, MN
Medical Components, Inc dba MedComp
Class II Terminated
Medcomp Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen Infusion Catheter, CT rated PICC, Split Cath III, PC Split Cath III; AngioDynamics product- Dura-Flow Catheter, Schon...
Reason: Medcomp has initiated the recall of Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen Infusion Catheter, CT rated PICC, Split Cath III, PC Split Cath III beca...
Z-1351-2015 April 8, 2015 Harleysville, PA
Cardiovascular Systems, Inc.
Class I Terminated
Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. The system is indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable c...
Reason: The OAD saline sheath outer layer may flake off from the catheter due to friction between the outer material layer and corresponding materials it may come in contact with during cl...
Z-1290-2015 April 1, 2015 Saint Paul, MN
Bard Access Systems
Class II Terminated
BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: SafeStep Port Access Kit 22G x 0.75in , SafeStep Port Access Kit 22G x 0.75in with Y-Site, SafeStep Port Access Kit 22G...
Reason: Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Bard includes these pouched syringes, attached to som...
Z-1273-2015 March 25, 2015 Salt Lake City, UT
Bard Access Systems
Class II Terminated
BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Groshong Midline Bard MYPICC Kit 4F (Single-Lumen) The syringe is used to pre-flush the catheter prior to placement an...
Reason: Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Bard includes these pouched syringes, attached to som...
Z-1275-2015 March 25, 2015 Salt Lake City, UT
Bard Access Systems
Class II Terminated
BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: PowerLoc Port Access Kit 19G x 1 in, PowerLoc Port Access Kit 20G x 1 in, , , PowerLoc Port Access Kit 20G x 1.5in, Power...
Reason: Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Bard includes these pouched syringes, attached to som...
Z-1272-2015 March 25, 2015 Salt Lake City, UT
Medtronic Inc. Cardiac Rhythm Disease Management
Class I Terminated
Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065. The FlexCath Select Steerable Sheath (10 Fr Select) is used for percutaneous catheter introduction into the vasculature and chambers of...
Reason: Clinicians observed debris, appearing to originate from the hemostasis valve on the proximal end of the Steerable Sheath, outside of the patients bodies.
Z-1276-2015 March 25, 2015 Saint Paul, MN
Bard Access Systems
Class II Terminated
BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: PowerGlide Midline Catheter Full Kit (20G) (8cm), PowerGlide Midline Catheter Maximal Barrier Tray (20G) (8cm), PowerGlid...
Reason: Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Bard includes these pouched syringes, attached to som...
Z-1274-2015 March 25, 2015 Salt Lake City, UT
Bard Access Systems
Class II Terminated
BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Bard Poly Midline 3F Full Tray (Single-Lumen) (with Microintroducer), Bard Poly Midline 3F Maximal Barrier Tray (Single-L...
Reason: Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Bard includes these pouched syringes, attached to som...
Z-1271-2015 March 25, 2015 Salt Lake City, UT
LeMaitre Vascular, Inc.
Class III Terminated
LeMaitre Vascular Tumescent Catheter Inversion (TCI) System. The TCI System is intended to provide a system to the removal of an incompetent greater saphenous vein. Catalog Number: 7210023, lot #6...
Reason: Mislabeled with an incorrect expiration date
Z-1294-2015 March 25, 2015 Burlington, MA
St Jude Medical
Class II Terminated
TactiSys Quartz Pack, PN-004 400. For percutaneous catheter radiofrequency (RF) ablation of atrial cardiac arrhythmias that allows visualization of the contact force between TactiCath quartz cath...
Reason: A configuration update needs to be done on TactiSys to appropriately recognize all TactiCath catheters.
Z-1284-2015 March 25, 2015 Saint Paul, MN
Arrow International Inc
Class II Terminated
Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS
Reason: Potential for a leak between the catheter and the bifurcate which would allow helium to escape to the atmosphere.
Z-1259-2015 March 18, 2015 Reading, PA
Arrow International Inc
Class II Terminated
ARROW FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5 Fr Product Code: IAB-05840-LWS The Arrow IAB is utilized for intra-aortic balloon counter-pulsation therapy in the aorta, whereby balloo...
Reason: Outer package product label incorrectly identifies the product as FiberOptix Flex IAB 7.5Fr rather than the correct FiberOptix IAB 8Fr
Z-1233-2015 March 11, 2015 Reading, PA