Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 132 of 138
Arrow International Inc
Class II Terminated
Arrow International, Inc. Two-Lumen CVC Kit with Blue Flex Tip Catheter. The multiple lumen catheter permits venous access to the central circulation of patients.
Reason: Arrow is recalling the product due to a labeling inconsistency. One portion of the lidstock states the kit contains a 3-Lumen catheter while the rest of the lidstock correctly iden...
Z-1965-2013 August 21, 2013 Reading, PA
Medtronic Inc. Cardiac Rhythm Disease Management
Class II Terminated
Medtronic Mullins Transseptal Adult 7F, REF 008551. Intended for the introduction of cardiovascular catheters into the left side of the heart.
Reason: Medtronic identified a specific labeling issue for specific lots of Mullins Transseptal Catheter Introducer Sheath, model 008551, in which packages labeled as Mullins 7F (French) m...
Z-1876-2013 August 14, 2013 Saint Paul, MN
Cordis Corporation
Class I Terminated
Cordis OPTEASE Retrieval Inferior Vena Cava (IVC) Filter***REF Cat. No.***466F220A and 466F220B***Vena Cava Filter and Introduction Kit***(BRITE TIP Catheter Sheath Introducer and Angiographic Vessel ...
Reason: Correction to provide clarification and additional labeling to minimize likelihood on implanting filter backwards.
Z-1887-2013 August 14, 2013 Miami Lakes, FL
Karl Storz Endoscopy America Inc
Class II Terminated
27023WU Balloon Catheter, 3 Fr., 2/pkg, sterile, contains latex. The RUSCH ureter occlusion catheter is indicated for the routine occlusion of the ureter to prevent the movement of stone fragment...
Reason: Karl Storz Endoscopy-America has initiated the recall of the 27023WU Balloon Catheter because the packaging may be compromised, and therefore the sterility of the product could be ...
Z-1728-2013 July 24, 2013 Southbridge, MA
Boston Scientific Corporation
Class II Terminated
Alair Bronchial Thermoplasty Catheter, Bronchial Thermoplasty System; Material Number: M005ATS25010, Catalog Number: ATS 2-5. Product is manufactured and distributed by Boston Scientific Corporation (...
Reason: Boston Scientific has discovered an inconsistent "Use By" expiration date on a single lot/batch of Alair Bronchial Thermoplasty Catheters. The expiration date indicated on the inn...
Z-1748-2013 July 24, 2013 Marlborough, MA
Boston Scientific Corporation
Class II Terminated
NephroMax high Pressure Nephrostomy Balloon Catheter. Material Number/Catalog Number: M0062101400/210-140, M062101440/210144 Dilation of the nephrostomy tract.
Reason: Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter.
Z-1672-2013 July 17, 2013 Marlborough, MA
Boston Scientific Corporation
Class II Terminated
NephroMax high Pressure nephrostomy Balloon Catheter Kit. Material Number/Catalog Number: M0062101600/210-160, M0062101640/210-164 Dilation of the nephrostomy tract.
Reason: Incorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter.
Z-1673-2013 July 17, 2013 Marlborough, MA
Bard Access Systems
Class II Terminated
StatLock CV Plus w/Pigtail, Catheter Stabilization Device Sterile EO Single Use Only, C.R. Bard, Inc. The StatLock¿ device provides stabilization for compatible medical tubes and catheters.
Reason: BARD Access Systems is recalling lot JUWJF283 of StatLock CV Plus Stabilization Butterfly Devices due to incorrect pad assembly used during manufacture. The absence of the hydrocol...
Z-1618-2013 July 10, 2013 Salt Lake City, UT
Biosense Webster, Inc.
Class II Terminated
20-Pole LASSO Nav Catheter Eco, Catalog # D-1349-02S. Designed to facilitate electrophysiological mapping of the atria of the heart.
Reason: Biosense Webster is recalling the 20-Pole LASSO NAV Catheter Eco because it has been incorrectly calibrated causing them to be recognized and displayed as a 10-Pole LASSO NAV Cathe...
Z-1617-2013 July 10, 2013 Irwindale, CA
Surgical Instrument Service And Savings, Inc.
Class II Terminated
- Relieva Flex Sinus Guide Catheter (Green) Tip Shape: F-70 Ref. GC070RF Lot 122429 - Relieva Luma Sentry 20 Tip Angle, 0.035 Diameter 100cm Ref. SIS100B Lot 122429 Manual surgical instrument fo...
Reason: The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch.
Z-1639-2013 July 10, 2013 Redmond, OR
Medtronic Inc. Cardiac Rhythm Disease Management
Class II Terminated
Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, 8F and Model # LA6IMAD, Lot # 0006724224, 6F Product Usage: The Medtronic Guiding Catheter is designed to provide a pat...
Reason: Medtronic has identified a labeling issue for 24 units of the Launcher coronary Guide Catheter. The two affected catheter lots are mislabeled and do not accurately reflect the cat...
Z-1564-2013 July 3, 2013 Saint Paul, MN
Medtronic Neuromodulation
Class I Terminated
Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and deli...
Reason: Medtronic Neuromodulation is providing Healthcare Providers with safety information and patient management recommendations related to the potential for electrical shorting internal...
Z-1579-2013 July 3, 2013 Minneapolis, MN
Medtronic Neuromodulation
Class I Terminated
Medtronic Intrathecal Catheter, model 8731SC. Contents: 38.1-cm spinal segment with length markings and guide wire, 66-cm pump segment, 15 T-gauge introducer needle, Transparent Strain-relief sleeve...
Reason: The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the potential for occlusion at the catheter to pump interface. Medtronic is removing the...
Z-1576-2013 July 3, 2013 Minneapolis, MN
Medtronic Neuromodulation
Class I Terminated
Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The SynchroMed EL Pumps are supplied in 10 ml or 18 ml reservoir size.) Sterilized using ethylene oxide. Product Usa...
Reason: Medtronic is providing Healthcare Professionals with important safety information and patient management recommendations regarding the unintended delivery of drug during the primin...
Z-1571-2013 July 3, 2013 Minneapolis, MN
Medtronic Neuromodulation
Class I Terminated
Medtronic Sutureless Pump Connector Revision Kit, model 8578. Contents: catheter interface with attached sutureless pump connector, catheter, connector pin, and strain-relief sleeve to be used with ...
Reason: The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the potential for occlusion at the catheter to pump interface. Medtronic is removing the...
Z-1573-2013 July 3, 2013 Minneapolis, MN
Medtronic Neuromodulation
Class I Terminated
Medtronic Intrathecal Catheter Pump Segment Revision Kit, model 8596SC. Contents: 60-cm pump segment with attached sutureless pump connector, Spinal Segment Strain-relief sleeves, Pump segment strai...
Reason: The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the potential for occlusion at the catheter to pump interface. Medtronic is removing the...
Z-1574-2013 July 3, 2013 Minneapolis, MN
Medtronic Neuromodulation
Class I Terminated
Medtronic SynchroMed EL Programmable pumps, Models 8626, 8626L, 8627, 8627L, (The SynchroMed EL Pumps are supplied in 10 ml or 18 ml reservoir size.) Sterilized using ethylene oxide. The pump is part ...
Reason: Medtronic Neuromodulation is providing Healthcare Providers with safety information and patient management recommendations related to the potential for electrical shorting internal...
Z-1580-2013 July 3, 2013 Minneapolis, MN
Medtronic Neuromodulation
Class I Terminated
Medtronic INDURA 1P Intrathecal Catheter, model 8709SC. Contents: 81.4-cm catheter with length markers and guide wire, 15 T-gauge introducer needle, Sutureless pump connector with attached 7.6-cm ca...
Reason: The Sutureless Connector (SC) Intrathecal Catheter connector has been redesigned to reduce the potential for occlusion at the catheter to pump interface. Medtronic is removing the...
Z-1575-2013 July 3, 2013 Minneapolis, MN
Terumo Medical Corporation
Class II Terminated
Terumo Glidesheath (tm), 6 French, Nitinol wire, product code 15-1060. Used to facilitate placing a catheter through the skin into a vein or artery.
Reason: Medical devices were incorrectly labeled with extended expiration dates.
Z-1612-2013 July 3, 2013 Elkton, MD
Loma Vista Medical
Class II Terminated
TRUE Dilatation Balloon Valvuloplasty Catheter, REF Numbers: 02045-11, 02245-12, 02445-12, and 02645-13; Sizes: 20mm x 4.5cm, 22mm x 4.5cm, 24mm x 4.5cm, and 26mm x 4.5cm; Intended to be use...
Reason: Slow deflation time: Slower than normal balloon deflation time of greater than 10 seconds. The balloon normally deflates in less than 5 seconds. The device performance specificat...
Z-1566-2013 July 3, 2013 Burlingame, CA
Medtronic Neuromodulation
Class I Terminated
Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. Product Usage: The pump is part of an infusion sys...
Reason: Medtronic is providing Healthcare Professionals with important safety information and patient management recommendations regarding the unintended delivery of drug during the primin...
Z-1570-2013 July 3, 2013 Minneapolis, MN
Bard Peripheral Vascular Inc
Class II Terminated
USHER¿ Support Catheter- Angled Tip WL130cm, RI 7F; REF USH07AT; PK1022-01A; Rx only, Non-Pyrogenic, Sterile; Bard Peripheral Vascular; Manuf: FlowCardia, Inc., a Subsidiary of C. R. Bard, Inc., 745...
Reason: Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard¿ UltraClip¿ Dual Trigger Tissue Marker's and support catheters (Microsheath and Usher) were...
Z-1529-2013 June 19, 2013 Tempe, AZ
Bard Peripheral Vascular Inc
Class II Terminated
BARD PERIPHERAL VASCULAR VACCESS¿ PTA Balloon Dilatation Catheters, 8mm x 4cm x 80cm. Product Usage: Vaccess¿ PTA Balloon Dilatation Catheters are recommended for use in Percutaneous Translumina...
Reason: Bard Peripheral Vascular (BPV) has confirmed that some product code/lot number combination of devices may have the incorrect balloon diameter labeled on the inflation hub. Specific...
Z-1533-2013 June 19, 2013 Tempe, AZ
Endologix Inc
Class I Terminated
Brand Name: AFX" Introducer System, Model Number S17-45. Lot Numbers: 1079840, 1079843, 1079844, 1079845. Product Usage: The AFX Introducer System is intended for use to facilitate the introducti...
Reason: Endologix, Inc. initiated this voluntary recall of certain lots of Endologix, Inc. due to reports of dilator breakage during clinical procedures.
Z-1436-2013 June 19, 2013 Irvine, CA
Bard Peripheral Vascular Inc
Class II Terminated
BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip¿ Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ultrasound Enhanced Coil Marker 5 Pack; Sterilize, Non-pyrogen...
Reason: Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard¿ UltraClip¿ Dual Trigger Tissue Marker's and support catheters (Microsheath and Usher) were...
Z-1526-2013 June 19, 2013 Tempe, AZ