Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 136 of 138
Cordis Corporation
Class II Terminated
Sleek OTW***REF 426-1201X***Inflated Balloon Dia/mm***1.25***Inflated Balloon Length/mm***15***Usable Catheter Length/cm***150*** Lot 50027149***2013-09***Cordis*** Sleek***OTW***REF Cat. No. 426-1201...
Reason: On 1/20/2011 Cordis Corporation , Miami Lakes, FL initiated a recall of their Sleek OTW PTA Dilatation Catheter Model #4261201X Lot #50027149 and Model #4261501X Lot #50026688. Pr...
Z-2441-2012 October 3, 2012 Miami Lakes, FL
Applied Medical Resources Corp
Class II Terminated
Irrigation Catheters (Models IRR-XXX-XX): Model Numbers & Description: IRR-023-10F,CATHETER IRRIGATION 10F 23CM; IRR-080-4F, CATHETER, IRRIGATION 4F 80CM; IRR-080-6F, CATHETER, IRRIGATION 6F 80C...
Reason: Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have a potential for packaging particulate matter to reside on the product.
Z-2448-2012 October 3, 2012 Rancho Santa Margarita, CA
Greatbatch Medical
Class II Terminated
Boston Scientific, Z Flex 270, Steerable Sheath, Sterile EO, Rx only, Distributed by Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, Manufactured by Greathbatch Med...
Reason: During the investigation of four returned Z Flex 270 Steerable Sheaths that were used with cardiac cryoablation balloon catheters, the internal PTFE sheath liners were found to dis...
Z-2459-2012 October 3, 2012 Minneapolis, MN
Abbott Vascular
Class II Terminated
Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature.
Reason: Abbott Vascular is recalling the Armada 35 and Armada 35 LL PTA Catheters because they have discovered that some devices may exhibit difficulty inflating and/or deflating.
Z-2450-2012 October 3, 2012 Temecula, CA
Micro Therapeutics Inc, Dba Ev3 Neurovascular
Class II Terminated
Marathon Flow Directed Micro Catheter, Model #105-5055. Product Usage: The Marathon Flow Directed Micro Catheter is intended to access the peripheral and neuro vasculature for the controlled select...
Reason: The recall was initiated because ev3 Neurovascular has identified one lot of UltraFlow Flow Directed Micro Catheters and Marathon Flow Directed Micro Catheters may have been mislab...
Z-2472-2012 October 3, 2012 Irvine, CA
Applied Medical Resources Corp
Class II Terminated
Biliary Catheters (Models A47XX and CB0XXXXX): Model Numbers & Description: A4752, SYNTEL BILIARY 5F-23CM CATHETER; A4754, SYNTEL BILIARY 5F-40CM CATHETER; A4762, SYNTEL BILIARY 6F-23CM CATHETER...
Reason: Applied Medical is recalling specific lot numbers of its Vascular Catheters because they may have a potential for packaging particulate matter to reside on the product.
Z-2447-2012 October 3, 2012 Rancho Santa Margarita, CA
Micro Therapeutics Inc, Dba Ev3 Neurovascular
Class II Terminated
UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065. Product Usage: The UltraFlow HPC Flow Directed Micro Catheter is intended to access peripheral and neuro vasculature for the controlle...
Reason: The recall was initiated because ev3 Neurovascular has identified one lot of UltraFlow Flow Directed Micro Catheters and Marathon Flow Directed Micro Catheters may have been mislab...
Z-2471-2012 October 3, 2012 Irvine, CA
US Endoscopy Group Inc
Class II Terminated
Infinity¿ sampling device, Cytology Brush, United States Endoscopy Group, Inc., 5976 Heisley Road, Mentor, OH 44060 The Infinity sampling device is a disposable cytology brush used to retrieve cyt...
Reason: US Endoscopy received five complaints which noted difficulty in deploying the cytology brush through the catheter.
Z-2396-2012 September 26, 2012 Mentor, OH
C.R. Bard, Inc., Urological Division
Class II Terminated
Bard Foley procedural trays packaged in breather bags. The product is packaged ten units in each shipper box, and are sold sterile for single use. Used to catheterize patients. The finished trays ...
Reason: Incomplete seal on sterile packages of product.
Z-2327-2012 September 19, 2012 Covington, GA
Biosense Webster, Inc.
Class II Terminated
CARTO 3 V1.05(FG-5400-00). The CARTO 3 V1.05 System is intended for catheter-based atrial and ventricular mapping. The mapping system allows real-time display of cardiac maps in a number of differe...
Reason: The recall was initiated because Biosense Webster has become aware of information regarding a potential hazard that may occur during the operation of a Bloom EP Stimulator device i...
Z-2369-2012 September 19, 2012 Irwindale, CA
Bard Access Systems
Class III Terminated
16 Fr HemoStar XK Long-Term Hemodialysis Catheter, implanted Standard kit containing an AirGuard introducer. The device is used for patients requiring hemodialysis. The HemoStar XK catheter is mad...
Reason: Bard Access Systems is recalling one lot of 16 Fr HemoStar XK Long Term Hemodialysis Catheters because they were identified with an incorrect expiration date, 03/2015 rather than 1...
Z-2277-2012 September 5, 2012 Salt Lake City, UT
Edwards Lifesciences, LLC
Class II Terminated
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141F7. For use in patients who require hemodynamic monitoring.
Reason: The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter.
Z-2193-2012 August 22, 2012 Irvine, CA
Teleflex Medical
Class III Terminated
TAUT, Cholangiogram Catheter Intraducer, Peritoneal Catheter, Teleflex Medical, Research Triangle Park, NC. An introduction/drainage catheter accessory is intended to aid in the manipulation of or ...
Reason: Product is missing the label on the internal packaging.
Z-2186-2012 August 22, 2012 Research Triangle Park, NC
Edwards Lifesciences, LLC
Class II Terminated
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model TS057HF7. For use in patients who require hemodynamic monitoring.
Reason: The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter.
Z-2198-2012 August 22, 2012 Irvine, CA
Edwards Lifesciences, LLC
Class II Terminated
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7P. For use in patients who require hemodynamic monitoring.
Reason: The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter.
Z-2195-2012 August 22, 2012 Irvine, CA
Edwards Lifesciences, LLC
Class II Terminated
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7P. For use in patients who require hemodynamic monitoring.
Reason: The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter.
Z-2189-2012 August 22, 2012 Irvine, CA
Edwards Lifesciences, LLC
Class II Terminated
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7P. For use in patients who require hemodynamic monitoring.
Reason: The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter.
Z-2191-2012 August 22, 2012 Irvine, CA
Edwards Lifesciences, LLC
Class II Terminated
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151HF7. For use in patients who require hemodynamic monitoring.
Reason: The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter.
Z-2197-2012 August 22, 2012 Irvine, CA
Edwards Lifesciences, LLC
Class II Terminated
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7J. For use in patients who require hemodynamic monitoring.
Reason: The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter.
Z-2190-2012 August 22, 2012 Irvine, CA
Edwards Lifesciences, LLC
Class II Terminated
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HVF7P. For use in patients who require hemodynamic monitoring.
Reason: The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter.
Z-2192-2012 August 22, 2012 Irvine, CA
Edwards Lifesciences, LLC
Class II Terminated
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7J. For use in patients who require hemodynamic monitoring.
Reason: The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter.
Z-2188-2012 August 22, 2012 Irvine, CA
Edwards Lifesciences, LLC
Class II Terminated
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7J. For use in patients who require hemodynamic monitoring.
Reason: The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter.
Z-2194-2012 August 22, 2012 Irvine, CA
Edwards Lifesciences, LLC
Class II Terminated
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151F7. For use in patients who require hemodynamic monitoring.
Reason: The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter.
Z-2196-2012 August 22, 2012 Irvine, CA
Angiodynamics Worldwide Headquarters
Class II Terminated
AngioDynamics Angiographic catheter --- Soft-Vu (JB-1) Non-braided. --- Size: 5F; Length: 100cm; designed to accept guidewire: .035 in. --- Catalog No. [REF]: 10734201. Packaged in boxes of 5 catheter...
Reason: AngioDynamics is recalling one lot of Soft-Vu Angiographic catheters because one of the catheter pouches within the outer box may be mislabeled.
Z-2180-2012 August 15, 2012 Latham, NY
ICU Medical, Inc.
Class II Terminated
Cardiac Catheterization Waste Management System w/1000mL Waste Bag, 2 Fluid Admin Sets Product Usage: For waste managment.
Reason: The firm initiated the recall due to a molding defect in a high pressure stopcock where a small percentage of the side ports could become totally occluded.
Z-2129-2012 August 8, 2012 San Clemente, CA