Data / Medical devices / United States / LivaNova USA, INC.
LivaNova USA, INC.: FDA-registered device maker in Arvada, CO, United States, 20 510(k) clearances
LivaNova USA, INC. is registered with the FDA (registration 1718850) in Arvada, CO, United States. It lists 18 device types. The FDA files 20 510(k) clearances under its listings, the newest dated August 8, 2024. 45 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1718850
- Address
- 14401 West 65TH Way, Arvada, CO, United States, 80004
- Owner or operator
- LivaNova (9003795)
- Roles
- Contract manufacturer, Contract sterilizer, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
- First device listed
- February 1, 2001
- Registered through
- 2027
- Brand names listed
- Air Aspirator, Aortic Arch Cannula, Aortic Root Cannula, BRAT2 System and Accessories, BSVD, Boncheck Vein Distention System, Brackets, Cannulation Tourniquet and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 8, 2024 | K233702 | SMARxT Tubing and Connectors | DWE | Substantially Equivalent | LivaNova USA, Inc. | accessdata.fda.gov |
| May 21, 2013 | K122735 | SORIN VASCULOOP TWO TIE ENDOSCOPIC LIGATION SYSTEM MODEL DTTS2 | GAT | Substantially Equivalent | Sorin Group USA, Inc. | accessdata.fda.gov |
| November 1, 2010 | K102983 | VASCUCLEAR PRECISION BIPOLAR | GEI | Substantially Equivalent | Sorin Group USA, Inc. | accessdata.fda.gov |
| October 24, 2007 | K070749 | ESTECH PERCUTANEOUS INSERTION DILATOR KIT | DRE | Substantially Equivalent | Coombs Medical Device Consulting | accessdata.fda.gov |
| September 7, 2000 | K000830 | CANNULATION TOURNIQUET SET, 2 TUBE OR 5 TUBE | DWF | Substantially Equivalent | California Medical Laboratories, Inc. | accessdata.fda.gov |
| February 8, 2000 | K993818 | ANTEGRADE/RETROGRADE PERFUSION ADAPTER WITH OR WITHOUT PRESSURE LINE | DWF | Substantially Equivalent | California Medical Laboratories, Inc. | accessdata.fda.gov |
| September 9, 1999 | K991986 | COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH THE CRIT-LINE HEMATOCRIT SAMPLING SYSTEM OPTION | CAC | Substantially Equivalent | Cobe Cardiovascular, Inc. | accessdata.fda.gov |
| October 26, 1998 | K981613 | COBE SMARXT TUBING AND CONNECTORS | DWE | Substantially Equivalent | Cobe Cardiovascular, Inc. | accessdata.fda.gov |
| October 7, 1998 | K982406 | COBE VACUUM RELIEF CHECK VALVE | MJJ | Substantially Equivalent | Cobe Cardiovascular, Inc. | accessdata.fda.gov |
| September 30, 1998 | K982891 | CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS | DTS | Substantially Equivalent | California Medical Laboratories, Inc. | accessdata.fda.gov |
| July 19, 1996 | K962070 | YSI 400 SERIES ATUOCLAVABLE REUSABLE TEMPERATURE PROBE | FLL | Substantially Equivalent | Yellow Springs Instrument Co., Inc. | accessdata.fda.gov |
| April 19, 1994 | K940936 | AESCULAP ENDOSCOPIC INSTRUMENTS | GEI | Substantially Equivalent | Aesculap, Inc. | accessdata.fda.gov |
| October 1, 1992 | K920312 | NEW COBE CARDIOPLEGIA SYSTEM | DTN | Substantially Equivalent | Cobe Cardiovascular, Inc. | accessdata.fda.gov |
| October 8, 1991 | K912019 | ORTHOFUSER WOUND DRAINAGE/AUTOTRANSFUSION SYSTEM | CAC | Substantially Equivalent | Gish Biomedical, Inc. | accessdata.fda.gov |
| April 10, 1990 | K900753 | SHILEY VEIN IRRIGATION CANNULA (BEVELED & BLUNT) | DWF | Substantially Equivalent | Shiley, Inc. | accessdata.fda.gov |
| June 10, 1988 | K881330 | COBE HEART/LUNG PERFUSION AND CARDIOPLEGIA PACK | DWF | Substantially Equivalent | Cobe Laboratories, Inc. | accessdata.fda.gov |
| February 10, 1986 | K854640 | MODIFIED CORONARY CARDIOPLEGIA ADAPTOR | DWF | Substantially Equivalent | Shiley, Inc. | accessdata.fda.gov |
| December 16, 1983 | K833322 | TUBING CONNECTORS EC-2XXX SERIES | DTL | Substantially Equivalent | Gish Biomedical, Inc. | accessdata.fda.gov |
| December 4, 1979 | K792134 | BONCHEK-SHILEY VEIN DISTENTION SYSTEM | DWP | Substantially Equivalent | Shiley, Inc. | accessdata.fda.gov |
| December 4, 1978 | K781990 | CARDIAC INSULATION PAD | DWF | Substantially Equivalent | Shiley, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 24, 2020 | 85623 | Class II | Terminated | Sterile Disposable Connectors ASY CONN Y 1/2X1/2X3/8 STR 24. REF/ GTIN for Insert Label:029165000/ 00803622123153 | The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is associated to a specific production period. | accessdata.fda.gov |
| February 24, 2020 | 85098 | Class II | Terminated | LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to circulate water through heat exchangers to warm or cool a patient during cardiopulmonary bypass procedures lasting 6 hours or less. | The firm is providing validated cleaning and disinfection instructions in their revised operating instructions to reduce the risk of NTM contamination. | accessdata.fda.gov |
| November 18, 2019 | 85858 | Class III | Terminated | LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case | Some packages of sterile disposable connectors contained a 3/8x1/4 reducer instead of the specified 1/2x1/2 connector. No significant risk to health is expected as the issue is easily detectable and the different shape would prevent use of the connector. | accessdata.fda.gov |
| July 3, 2019 | 84732 | Class III | Terminated | LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing pack use in surgical procedures requiring extracorporeal support. The perfusion tubing packs include the cuvette used w | Perfusion tubing pack was packaged with the incorrect cuvette. | accessdata.fda.gov |
| January 28, 2019 | 84142 | Class III | Terminated | LivaNova Sorin Connect DPIII KOMPL. S5 REF 96-415-130, 2017-08-15, IPX1, RXOnly, (01)04033817901594 Product Usage: The S5 System is used to perform, control and monitor extracorporeal blood circulation during an operatio | Incorrect labeling; it was identified that some Datapad devices contained incorrect labels. Specifically the manufacturing date in the production identifier was incorrect and the manufacturing date on the unique device identifier label was labeled in the format of yy-mm-dd instead of yyyy-mm-dd. | accessdata.fda.gov |
| November 9, 2018 | 81667 | Class II | Terminated | Perfusion Pack, Rx only, Sterile EO | 4-way stopcocks and stopcock manifold assembled in certain perfusion tubing systems, indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours, may leak or be occluded. | accessdata.fda.gov |
| November 1, 2018 | 83822 | Class II | Terminated | SORIN Heater-Cooler System 3T 120V~/60Hz REF 16-02-85 Description of product: The Stckert Heater-Cooler System is an independent (i.e. independent of the water supply) 3-circuit-heating/cooling system. The three separate | The firm has become aware that due to a chemical reaction, the disinfectant/water preservative used to disinfect the device to inhibit/limit the growth micro-organisms, may be rendered ineffective. In addition, the firm is releasing a design upgrade to reduce the risk of potential emission of aerosols from the 3T. | accessdata.fda.gov |
| September 14, 2018 | 82365 | Class II | Terminated | SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stockert/Sorin S3/S5/C5 heart-lung machine and/or any other heart-lung machine featuring a separate temperature control for extracorporeal perfusion of | For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM). | accessdata.fda.gov |
| April 20, 2018 | 80072 | Class II | Terminated | Sorin Stockert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz; b) Item #: 16-02-82, 208 v/60 Hz; c) Item #: 16-02-85, 120 v/60 Hz | Firm is notifying customers that the Deep-Cleaning Service is now available in the United States. Stockert Heater-Cooler System 3T devices are suspected of microbial contamination and may contain visible biofilm. | accessdata.fda.gov |
| March 13, 2018 | 79863 | Class II | Terminated | Inspire 6 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050713 The intended uses for the two elements that constitute the oxygenator/reservoir integrated devices are: INSPIRE 6M Hollow Fiber Oxygenator: T | Some integrated sterile INSPIRE family products contain an incorrect expiration date printed in the Unique Device Identification (UDI) bar code and readable code just beneath the barcode. Specifically, the expiration date is reported as DDMMYY instead of YYMMDD. The expiration date in the applicable field on the package labels are correct as printed. | accessdata.fda.gov |
| December 19, 2017 | 79000 | Class III | Terminated | Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx. The firm name on the label is Sorin Group USA, Inc., Arvada, CO. | The product is labeled with the incorrect expiration date. | accessdata.fda.gov |
| September 28, 2017 | 78331 | Class II | Terminated | FlexFlow Venous Cannula Model/Catalog Number The FlexFlow Venous Cannula is a single use sterile device. It is a size 23 French with an outside diameter of 0.30 inch (7.7 mm) and an effective working length of 11.2 inch | A specific lot of the FlexFlowTM Venous Cannula,, is being recalled because it is sharper or pointier than expected. | accessdata.fda.gov |
| June 30, 2017 | 77717 | Class II | Terminated | STOCKERT Heater-Cooler System 3T, 230 V | Plastic heat exchanger fibers separating the blood compartment from the water compartment in certain oxygenators may allow diffusion of hydrogen peroxide in a quantity that exceeds allowable limits. | accessdata.fda.gov |
| June 29, 2017 | 77810 | Class II | Terminated | SORIN GROUP, SMART PERFUSION PACK, LONG PACK, REF 088512600, STERILE EO, Rx Only, 1 EA | Medtronic informed LivaNova that some of their DLP Pressure Disposable Display Sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). The result is a potential sterile barrier breach in the display sets. These display sets are included with LivaNova Perfusion Tube Sets (PTS) which were then distributed to customer | accessdata.fda.gov |
| June 9, 2017 | 77699 | Class II | Terminated | Sorin Group Aortic Arch Cannula, 7 mm x 10 in x 3/8 in, Rx Only, Sterile Product Usage: The Aortic Arch Cannulae are indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. | Identification of excess plastic on the tip of the cannula. | accessdata.fda.gov |
| October 31, 2016 | 75570 | Class II | Terminated | Perceval Sutureless Aortic Heart Valve size S, Item # ICV1208, REF PVS21; Perceval Sutureless Aortic Heart Valve size M, Item # ICV1209, REF PVS23; Perceval Sutureless Aortic Heart Valve size L, Item # ICV1210, REF PVS25 | Sorin Group USA, Inc. announces a voluntary field action for the Perceval Sutureless Heart Valve due to updated steps associated with the implantation procedure. | accessdata.fda.gov |
| September 29, 2016 | 75456 | Class II | Terminated | The ORCHESTRA Programmer A portable device, equipped with a microprocessor used to program and interrogate Sorin implantable pacemakers and defibrillators. The programmer also provides measurement, ECG display and report | Sorin Group USA, Inc. announces a voluntary field action for the ORCHESTRA Programmer and ORCHESTRA PLUS Programmer because the residual longevity estimate may be less accurate. | accessdata.fda.gov |
| August 25, 2016 | 75036 | Class II | Terminated | Stckert S5 System, S5 Heart-lung machine, Cardiopulmonary bypass heart-lung machine console Product Usage: The Stckert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours o | Sorin/LivaNova is initiating a field correction on the S5 Heart-lung machine because of the potential for failure of the Uninterruptible Power Supply. | accessdata.fda.gov |
| August 12, 2016 | 74934 | Class II | Terminated | Aortic Arch Cannula and Coronary Artery Perfusion Cannula with Ballon (part number NA-55X6). The Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery. The cannu | Sorin Group USA, Inc. announces a voluntary field for the Aortic Arch Cannula and Coronary Artery Perfusion Cannula With Ballon because the tip of the cannula should be bent at either a 45 or 90 degree angle. Samples have been returned where the angle of the tip is less than the requirement. | accessdata.fda.gov |
| June 22, 2016 | 74490 | Class II | Terminated | AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (part numbers NA-55X7 and NA-55X8) Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary byp | Sorin Group USA is recalling Aortic Arch Cannulae (part numbers NA-55X7 and NA-55X8) because the distal end may be less than specified. The defective cannula are showing an angle that is about 15-20 degrees instead of approximately 45 degrees. | accessdata.fda.gov |
| January 25, 2016 | 73224 | Class II | Terminated | Dual Stage Venous Return Catheter, Low-Profile, wire reinforced (36F/46F, Sterile), Model Number: LRD-61046, Expiration 10/31/2018, Product is packed in a sealed pouch, ten (10) pouches per case. Cardiopulmonary bypass c | Sorin Group initiated field correction for the Dual Stage Venous Return Catheter because the incorrect Instructions For Use (IFU) was packaged in the case. | accessdata.fda.gov |
| January 19, 2016 | 73126 | Class III | Terminated | CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Perfusion Pack or Smart Perfusion Pack. Product Usage: Heart/Lung Perfusion Pack is either a customized tubing pack built to user specifications | The CDI System 500 monitor displays the "H/S DISCONNECT AT CUVETTE" error message when the CDI HIS Cuvette does not make a proper connection with the CDI H/S Probe. When this occurs, blood parameter values for HCT, Hgb and S02 do not display. | accessdata.fda.gov |
| June 15, 2015 | 71593 | Class II | Terminated | Sorin Stockert Heater-Cooler 3T, 230 V Temperature control for extracorporeal perfusion of durations up to 6 hours. | Potential colonization of organisms, including Mycobacteria, in Sorin Heater Cooler Devices, if proper disinfection and maintenance is not performed per Instructions for Use. | accessdata.fda.gov |
| August 1, 2014 | 75573 | Class II | Terminated | STCKERT HeaterCooler System 3T; Item Number 160281, HeaterCooler 3T, 240V/60Hz; Item Number 160282, HeaterCooler 3T, 208V/60Hz; Item Number 160285, HeaterCooler 3T, 120V/ 60Hz The Heater Cooler 3T is used with a Stckert | On August 1, 2014 Sorin Group USA, Inc. informed consignees via letter to review the disinfection and monitoring practices and to strictly adhere to the instructions in the Instructions for Use (IFU). | accessdata.fda.gov |
| July 8, 2013 | 65869 | Class II | Terminated | Edwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/Lung Perfusion Packs. | Sorin Group is recalling certain lots of Edwards Lifesciences Suction Wand Model S099B due to presence of plastic particles inside the pouch. | accessdata.fda.gov |
| January 28, 2013 | 64344 | Class II | Terminated | Isoline Implantable Defibrillation Lead, Model Isoline 2CR5, 2CR6 and 2CT6. These lead models are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatenin | Isoline defibrillation leads distributed may have internal insulation breach. | accessdata.fda.gov |
| September 20, 2012 | 63381 | Class II | Terminated | SCP Pump Control Panel, Product Code: 60-02-15, Serial Numbers: 60S09121, 60S09123-60S09129, 60S09136-60S09139. The SCP is a cardiopulmonary bypass speed control device indicated for use exclusively with the COBE Revolut | Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Stockert Centrifugal Pump (SCP) Pump Control Panel. An out of specification circuit board component within the Panel may lead to a malfunction consisting of a blank or flashing display. The flow and pressure display information may also be incorrect after t | accessdata.fda.gov |
| September 19, 2012 | 63383 | Class II | Terminated | S5 Single Roller Pump 150, Item Number: 10-80-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less. | Sorin Group USA, Inc. has issued an Urgent Field Safety Notice regarding certain serial numbers of the Sorin Group S5 Perfusion System due to reports of a "Fault in motor controller" alarm message displayed on the system panel. This could lead to unintended pump stoppage which may result in permanent impairment or life-threatening injury. An out of specifica | accessdata.fda.gov |
| September 14, 2012 | 63361 | Class II | Terminated | Gish 3/8 x 3/8" Straight Connector with Luer fitting, Item Numbers: EC2160B, EC2160S, Lot Numbers: 1210100010, 1215100026, 1217000138, Exp. Dates: 4/16/17, 5/31/15, 7/31/15. Product Usage: The connectors are indicated fo | Due to a molding irregularity, certain lots of connectors have the potential to leak fluid or entrain air at the interface of the luer fitting and mating cap. Entrained air could result in patient injury. | accessdata.fda.gov |
| August 15, 2012 | 73352 | Class II | Terminated | Stockert Heater-Cooler 3T; Item Number 16-02-8, H3T/240V/60Hz; 16-02-82, H3T208V/60Hz; 16-02-85, H3T/120V/60Hz. Device Listing E572259 | On August 15, 2012, Sorin informed consignees via letter of changes made to create Version 12 of the Heater-Cooler 3T IFU. The revised IFU included enhancements to achieve water quality that meets the standard for German drinking water. | accessdata.fda.gov |
| February 16, 2012 | 61208 | Not yet classified | Terminated | Stockert, S5 Roller pump 150, Part 10-80-00, Sorin Group Deutschland GMBH, Lindberghstrasse 25, 80939 Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004, USA The S5 System is used to perform, co | Touch screen may be unresponsive, inhibiting user input. | accessdata.fda.gov |
| December 2, 2011 | 60737 | Not yet classified | Terminated | Apex Oxygenator, Sterile EO, Distributed in U.S. by: Sorin Group USA, Inc, 14401 W. 65th Way, Arvada, CO 80004, manufactured by: Sorin Group Italia, Via Statale 12 Nord, 86, 41037 Mirandola (MO) Italy. Intended for use i | Customer complaints of a leak between the blood and water compartments of the heat exchanger used in the oxygenators due to prolonged contact of the heat exchangers with sodium chloride causing micro-holes. | accessdata.fda.gov |
| November 12, 2010 | 57609 | Not yet classified | Terminated | Stockert, S5 Roller Pump 150, Part No.: 10-80-00, Sorin Group Deutschland Gmbh, Lindberghstrasse 25, Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004. Used to perform, control and monitor extr | Touch screen may become unresponsive, inhibiting user input. | accessdata.fda.gov |
| October 7, 2010 | 57052 | Not yet classified | Terminated | Sorin OptiPack, Perfusion Tubing Set, Sterile EO, REF 082500200, Manufactured by Sorin Group USA, Inc. 14401 W. 65th Way Arvada, CO 80004 Indicated for use in surgical procedures requiring extracorporeal support for peri | Defective product packaging may compromise product sterility. | accessdata.fda.gov |
| June 18, 2010 | 56139 | Not yet classified | Terminated | Mast Roller Pump, Catalog 50-80-00, for use with Sorin HLM C5 and HLM S5. | Although accessories were designed for use with two models, the HLM C5 and the HLM S5, the submission that included references to the Mast Roller Pump, B-Care5, and the Electrical Venous Line Occluder accessories covered the new HLM S5 system. The three accessories were not cleared for use with the HLM C5. | accessdata.fda.gov |
| December 30, 2009 | 54250 | Not yet classified | Terminated | Opti-Pack Smart Perfusion Pack, REF: 086500100, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004 Indicated for use in surgical procedures requiring extracorporeal support for periods of up to six ho | Tubing set packaging seal between lid and tray may not be adequately sealed, compromosing sterility. | accessdata.fda.gov |
| November 25, 2009 | 54000 | Not yet classified | Terminated | Sorin / Clearglide EVH Small, REF KTV15, Sterile R, Manufactured for: Sorin Group USA, Inc., 14401 W.65th Way, Arvada, CO 80004. The device is indicated for endoscopic and open tissue dissection, bipolar coagulation, and | Vessel clamping device may break during use. | accessdata.fda.gov |
| September 25, 2009 | 53543 | Not yet classified | Terminated | Revolution Blood Pump, "revOlution Centrifugal pump Catalog# 050300000***Rx ONLY***SORIN GROUP ITALIA via Statale 12 Nord, 86 41037 MIRANDOLA (MO) (Italy) Distributed in the U.S. by: Sorin Group USA, Inc. 14401 W. 65th w | A weakness in the plastic packaging tray could cause the tray to crack; compromising product sterility. | accessdata.fda.gov |
| August 8, 2008 | 49378 | Not yet classified | Terminated | Dideco, D901 Lilliput 1, Close Phisio, Sterile EO, REF 05252, Manufacturer: Sorin Group Italia, Via Statale 12 Nord, 86, 41037 Mirandola (MO) (Italy). The product is intended for use in cardiopulmonary bypass circuits as | Under certain conditions, venous reservoir on oxygenator may allow air into the system. | accessdata.fda.gov |
| August 4, 2006 | 36168 | Not yet classified | Terminated | dideco Preassembled Surgical Wash Set, Compact, Cobe part numbers WS55C, WS125C, WS225C, Cobe Cardiovascular, Inc. | Foreign particles-manufacturing error may lead to abrasion of bowl seal in blood recovery sets, possibly causing particles in the blood. | accessdata.fda.gov |
| June 26, 2006 | 35839 | Not yet classified | Terminated | Cobe Optima XP Hollow Fiber Membrane Oxygenator/Reservoir, Sterile, (Standalone Systems) Catalog Numbers 050255500, 050316400, 050412400, 050500000. COBE Cardiovascular, Inc.. | Cooling and rewarming time is extended. Efficiency of the heat exchangers is reduced because many of the folds that are critical to heat exchange on the blood side of the units were blocked with a metalic material, thus decreasing the surface area needed for proper heat transfer. | accessdata.fda.gov |
| October 6, 2005 | 33842 | Not yet classified | Terminated | Custom heart lung perfusion packs | One way valve in the heart lung pack assembly may be missing. | accessdata.fda.gov |
| June 22, 2005 | 32561 | Not yet classified | Terminated | ASY Brat 2 Procedure Set, for blood recovery & autotransfusion. | Packaging trays may have holes in them as a result of the sealing process, which could compromise the sterility of the product. | accessdata.fda.gov |
| May 25, 2004 | 29261 | Not yet classified | Terminated | Cardioplegia Pack BCD Vanguard Ratio 4:1 with Shunt | Some Cardioplegia Delivery Sets, 4:1 w/shunt, were misassembled with 1:1 tubing sub-assemblies. This would provide 2 1/2x the desired cardioplegia. | accessdata.fda.gov |
| May 9, 2003 | 26361 | Not yet classified | Terminated | Cobe Cardiovascular BCD Vanguard Cardioplegia Delivery System, 8:1 with Shunt. | Tubing set included in Cardioplegia Delivery System was 4:1 instead of the labeled 8:1 size. | accessdata.fda.gov |
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Updated August 8, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.