Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 94 of 138
Arrow International Inc
Class II Terminated
Arrow(R) VPS(R) Access Kit for use with 4 and 5 Fr. Peripherally Inserted Central Venous Catheters
Reason: Arrow International is notifying each customer who received the affected that product that the kits do not contain important information regarding the 3M Tegaderm CHG Chlorhexidine...
Z-2170-2017 June 7, 2017 Reading, PA
Vascular Solutions, Inc.
Class II Terminated
Dolphin Inflation Device, REF 0185NA. Rx only, Sterilized using Ethylene Oxide. DOLPHIN is a single-use, sterile inflation device used in cardiovascular procedures to pressurize (inflate) and de...
Reason: The manufacturer of the DOLPHIN inflation device, Perouse Medical, has initiated a recall of the device due to a potential defect in the sterile barrier. Use of affected product c...
Z-2180-2017 June 7, 2017 Maple Grove, MN
Teleflex Medical
Class II Terminated
PE CONNECTOR 3/8 STRAIGHT 20/BX, Sterile, Single use, Product Usage: Catheter Connector/Accessory
Reason: Labeling: The expiration date is not stated on the labeling, there is a potential for expired product to be used.
Z-2127-2017 May 31, 2017 Research Triangle Park, NC
Siemens Medical Solutions USA, Inc
Class II Terminated
AXIOM Sensis, Computer, Diagnostic, Programmable. Intended to be used as a diagnostic and administrative tool supporting hemodynamic cardiac catheterizations and/or intracardiac electrophysiology s...
Reason: An extremely dusty computer can cause problems at system start, or rarely, cause system fail. Perform a system check prior to performing exams. If the Sensis system fails, its func...
Z-2156-2017 May 31, 2017 Malvern, PA
Datascope Corporation
Class II Terminated
SENSATION PLUS¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ Product Code/Part Number: 0684-00-0576-01U is a cardiac assist device which support the heart's left ventricle...
Reason: Maquet/Getinge is initiating a voluntary product removal involving four lot numbers of SENSATION PLUS 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK since du...
Z-2164-2017 May 31, 2017 Fairfield, NJ
Teleflex Medical
Class II Terminated
INFANT 20/BX, Sterile, Single use Product Usage: Catheter Connector/Accessory
Z-2130-2017 May 31, 2017 Research Triangle Park, NC
Teleflex Medical
Class II Terminated
PE CONNECTOR 3/8 Y 20/BX, Sterile, Single use, Product Usage: Catheter Connector/Accessory
Reason: Labeling: The expiration date is not stated on the labeling, there is a potential for expired product to be used.
Z-2128-2017 May 31, 2017 Research Triangle Park, NC
Teleflex Medical
Class II Terminated
PE CONNECTOR 5 IN 1 20/BX, Sterile, Single use, Product Usage: Catheter Connector/Accessory
Reason: Labeling: The expiration date is not stated on the labeling, there is a potential for expired product to be used.
Z-2129-2017 May 31, 2017 Research Triangle Park, NC
Bard Access Systems Inc.
Class II Terminated
StatLock¿ IV Premium Catheter Stabilization Device, product code IV0570. sterile. Packaging: packaged as single units in tyvek to film pouches, the product is distributed in cartons containing 25 d...
Reason: StatLockTM IV Premium Catheter Stabilization Device may contain an incorrectly sized retainer clip.
Z-2120-2017 May 31, 2017 Salt Lake City, UT
Abbott Vascular
Class I Terminated
NC Traveler RX Coronary Dilatation Catheter, Part No. 1013152-12, 1013152-15, 1013152-20, 1013153-08, 1013153-12, 1013153-15, 1013153-20, 1013154-08, 1013154-12, 1013154-15, 1013154-20, 1013155-08, 1...
Reason: Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the balloon.
Z-2038-2017 May 24, 2017 Temecula, CA
Abbott Vascular
Class I Terminated
NC Trek RX Coronary Dilatation Catheter, Part No. 1012448-06, 1012448-08, 1012448-12, 1012448-15, 1012448-20, 1012449-06, 1012449-08, 1012449-12, 1012449-15, 1012449-20, 1012449-25, 1012450-06, 101245...
Reason: Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the balloon.
Z-2037-2017 May 24, 2017 Temecula, CA
ReFlow Medical
Class I Terminated
Wingman 35 Crossing Catheter, 65cm, Model Numbers: WGM35065US WGM35065CE WGM35090US WGM35090CE WGM35135US WGM35135CE
Reason: ReFlow Medical is recalling the Wingman 35 Crossing Catheter because it may be prone to tip detachment.
Z-1898-2017 May 24, 2017 San Clemente, CA
Abbott Vascular
Class I Terminated
NC Tenku RX PTCA Balloon Catheter, Part No. 1012448-08T, 1012448-12T, 1012448-15T, 1012449-08T, 1012449-12T, 1012449-15T, 1012450-08T, 1012450-12T, 1012450-15T, 1012451-08T, 1012451-12T, 1012451-15...
Reason: Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the balloon.
Z-2039-2017 May 24, 2017 Temecula, CA
Mederi Therapeutics, Inc
Class II Terminated
Mederi Stretta Catheter and Accessory Kit, Sterile For Use with the MEDERI MDRF1 GENERATOR ONLY. Used in the treatment of gastroesophageal reflux disease (GERD). REF 175-5580
Reason: Product sterility compromised due to breach in sterile barrier package
Z-2050-2017 May 17, 2017 Norwalk, CT
Becton Dickinson & Company
Class II Terminated
BD FlowSmart Set MiniMed Pro-set Rx Only Distributed by Medtronic MiniMed Inc. 8006464633 8185765555 Legal Manufacturer Becton, Dickinson and Company USA BD Medical-Diabetes Care Bec...
Reason: Patients are reporting high blood glucose (HBG) levels while using the MiniMed Pro-set and also noticed the catheter of the infusion set was bent/kinked.
Z-1897-2017 May 10, 2017 Franklin Lakes, NJ
Boston Scientific Corporation
Class II Terminated
The JETSTREAM is a rotational atherectomy catheter system designed for use in debulking and treating vascular disease in the peripheral vasculature. The System includes multiple distal ports located ...
Reason: Boston Scientific is initiating a voluntary removal of two lots of JETSTREAM SC 1.85mm and one lot of JETSTREAM XC 2.1mm Atherectomy Catheters due to these units being mislabeled. ...
Z-1922-2017 May 10, 2017 Maple Grove, MN
Terumo Medical Corporation
Class II Terminated
SurFlo IV Catheter
Reason: According to the Terumo (TMC) this device is used to access the human peripheral vascular system for short term use (less than 30 days) for the purpose of infusing fluids into pati...
Z-1896-2017 May 10, 2017 Elkton, MD
Arrow International Inc
Class II Terminated
Pressure Injectable Arrowg+ard Blue Plus Multi-Lumen Central Venous Catheterization Kit. Permits venous access to central circulation by way of subclavian, jugular and femoral veins. The ARROWg+ard t...
Reason: Arrow International is recalling due to possible voids in the catheter hub, which could lead to an interlumen crossover.
Z-1879-2017 May 3, 2017 Reading, PA
Cook Inc.
Class II Terminated
Bush DL Ureteral Illuminating Catheter Set Bush SL Ureteral Illuminating Catheter Set
Reason: Product may overheat, melt, and burn patient.
Z-1870-2017 April 26, 2017 Bloomington, IN
Volcano Corporation
Class II Terminated
Refinity Rotational Intravascular Ultrasound (IVUS) Catheter; Product number: 400-0200.289; Catalog number 89800. Cardiovascular: The REFINITY (or REFINITY ST) Rotational IVUS Catheter (REFINIT...
Reason: High complaint rates of kinking near the junction of the proximal shaft to telescope section of the catheter. Kinking could result in disruption of normal clinical workflow or los...
Z-1775-2017 April 19, 2017 Rancho Cordova, CA
Micromedics, Inc.
Class II Terminated
Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number SA-3445. Sterilized using Ethylene Oxide
Reason: The sterile packaging may contain small channels in the seal of the pouch, If the channels are present, the package integrity may be compromised which may affect sterility assuran...
Z-1817-2017 April 19, 2017 Saint Paul, MN
Merit Medical Systems, Inc.
Class II Terminated
The PreludeSYNC Radial Compression Device is a sterile, single use disposable device used to assist in gaining and maintaining hemostasis of the radial and ulnar artery following catheterization proce...
Reason: Merit Medical Systems, Inc. announces a voluntary field action for the PreludeSYNC Radial Compression Device because particulate generated during the manufacturing process may ente...
Z-1766-2017 April 19, 2017 South Jordan, UT
Merge Healthcare, Inc.
Class II Terminated
Merge Hemo software. The firm name on the labeling is Merge Healthcare, Hartland, WI. Merge Hemo monitors, measures, and records physiologic data from a human patient undergoing a cardiac catheteriz...
Reason: Use of the software may show an incorrect value to the user when viewing the Fractional Flow Reserve (FFR) results during recording.
Z-1778-2017 April 19, 2017 Hartland, WI
Boston Scientific Corporation
Class II Terminated
Boston Scientific Imager II Angiographic Catheter, M001316581 (5-pack outer package UPN), M001316580, single unit, inner package UPN)
Reason: One lot of Imager II Angiographic Catheters is being recalled due to packaging mislabeling. The product may be labeled as Imager II Contra 2 curve catheters, when in fact the pack...
Z-1781-2017 April 19, 2017 Maple Grove, MN
Volcano Corporation
Class II Terminated
Refinity Short Tip Rotational Intravascular Ultrasound (IVUS) Catheter; Product number: 400-0200.273; Catalog number 89900. Cardiovascular: The REFINITY (or REFINITY ST) Rotational IVUS Cathete...
Reason: High complaint rates of kinking near the junction of the proximal shaft to telescope section of the catheter. Kinking could result in disruption of normal clinical workflow or los...
Z-1776-2017 April 19, 2017 Rancho Cordova, CA