Heparin

Serious injuries and deaths have been associated with the use of heparin, a blood-thinning drug that contained active pharmaceutical ingredient (API) from China. The adverse events have included allergic or hypersensitivity-type reactions, with symptoms such as low blood pressure, angioedema, shortness of breath, nausea, vomiting, diarrhea, and abdominal pain.

In February 2008, Baxter Healthcare Corporation recalled multi-dose and single-dose vials of heparin sodium for injection, as well as HEP-LOCK heparin flush products. After launching a far-ranging investigation, FDA scientists identified a previously unknown contaminant in the heparin. Contaminated heparin has also been found in association with some medical devices, such as certain catheters. Some of these medical devices have been recalled.

Based on experiences with injectable drug products, the contaminated heparin could be associated with various clinical events including severe allergic reactions, gastrointestinal symptoms (nausea, vomiting, abdominal pain, and diarrhea) and/or very low blood pressure. Although it is also possible that contaminated heparin may cause inaccurate results of in-vitro diagnostic tests (IVDs) that utilize heparin either as part of the assay or as part of the specimen collection, to date no testing problems have been reported. Because clinical care decisions might be based on inaccurate test results, laboratories and clinicians should continue to follow usual quality control practices to assure that tests generated are reliable.

Some medical devices contain and/or are coated with heparin, and some IVDs are manufactured using heparin. CDRH and manufacturers are aware that some devices have been affected by the recent contamination. Products coated with, containing or manufactured with heparin that may be affected include:

  • Heparin lock flush solutions in vials and solutions in pre-filled syringes
  • Devices used during cardiopulmonary bypass procedures, including certain oxygenators, filters, reservoirs, and cannulae
  • Catheters including certain vascular access catheters, drainage, retransfusion and thermodilution catheters, and oximetry probes
  • Certain vascular stents and grafts
  • Certain assisted reproduction media devices
  • Certain In-Vitro Diagnostic media and related devices

IVDs that may be affected include specialized devices such as tests that measure heparinís effect in the body, and more general and widely used devices such as tubes containing heparin that are used to collect unclotted blood for various kinds of testing. Other examples include the following:

  • IVDs that are used to monitor (or are affected by) heparin that has been injected into patients
  • IVDs that incorporate heparin as part of the device itself
  • IVDs that rely on heparin as part of the manufacturing process

Medical Devices and Diagnostic Products that May Contain or Be Coated with Heparin

This list is not meant to be exhaustive and will be updated as additional information becomes available. It is for information purposes only. FDA does not mean to suggest, in any way, that the products herein have been or are affected by contaminated heparin. Items in [brackets] are in-vitro diagnostic products.

Manufacturer or Distributor Product
3M Health Care 3M CDI Quick-Cells with Heparin Treatment
3M Sarns Flow Sensor , Centrifugal Control Module
Sarns Arterial Cannulae with Duraflo Treatment
Sarns Venous Return Catheters with Duraflo Treatment
A-Med Systems, Inc. Heparin Coated Miniature Centrifugal Bypass Pump
AMO Groningen BV CEEON Heparin Surface Modified UV Light-Absorbing Posterior Chamber IOLs
CEEON Heparin Surface Modified UV Light-Absorbing Anterior Chamber IOLs
Akers Labs [Platelet Factor 4 RIA]
Alsius Coolgard and catheter thermal regulation system
Thermogard System
ICY Catheter Models IC3583 and IC3893
Quattro Catheter IC4593
Fortius Catheter
AM2 PAT Inc. Sierra Heparin Flushes
American Bentley Heparin Coated Arterial Blood Filters
Heparin Coated Extracorporeal Circuits
American Edwards Laboratories Heparin Coated Catheter
Swan-Ganz Heparin Coated Catheter
American Bioproducts [Ptt-Lt]
[Stachrom Heparin]
American Dade [Lithium Heparinized Blood Collect-Tube]
[Actin Fs APTT]
American Diagnostica [Actichrome Heparin]
Amsino Medical USA Heparin Flushes
APP Heparin Flushes
Argon Medical Corporation Heparin Coated Stainless Steel and Teflon Heparin-Coated Guidewires
Heparin Coated Thermodilution Catheters
Arrow International, Inc. Arrow-Howes large bore multi-lumen central venous catheter
HANDS-OFF Heparin Coated Thermodilution Catheters
Artefactos De Vidrio S.A. De C.V. [Ven-O-Vac Blood Collection Vacuum Tubes]
Atrium Medical Atrium Heparin Coated Catheters
Avecor Cardiovascular Inc. Affinity Hollow Fiber Oxgenator with Trillium Biopassive Surface
Avitro LLC Heparin Flushes
B. Braun of America H.E.L.P System
Heparin Flushes
Baxter Bentley Laboratories Duraflo II Heparin Treated Suction Wands
Duraflo II Heparin Treated Femoral Cannulae
Baxter Edwards Carpenter-Edwards Classic Ring with Duraflo Treatement
Baxter Healthcare Corp. Hep-LOCK Heparin Flushes
Becton Dickson B-D Heparinized Longdwel IV Catheter
Heparin Coated Thermodilution Catheter
Heparin Coated Luminal Pacing Catheter
Heparin Flushes
[Vacutainer Brand Plus Sodium Heparin Tube]
[Bd Vacutainer Plus Pst Ii Tube]
[Vacutainer Brand Blood Collection Syringe]
Bio/Data Corp [Cephalinex APTT]
Biosensors Intl PTE, LLC Heparin Coated Thermodilution Catheters
Biotrack, Inc Biotrack APTT
Boston Scientific Corp Constellation Multiple Electrode Pacing and Recording System
Cardiac Assist, Inc. TandemHeart Transseptal Cannula Set-EF
Cardiovascular Diagnostic Services [Aoag-1 APTT Test Card]
Cardiovascular Diagnostics [(Tas) Low Range Heparin]
Careside Hemotology [APTT]
Celsus Heparin Flushes
Ciba Corning Diagnostics Corp. [Ciba Corning Blood Collection Capillary Tube]
Coaxia Inc Coaxia Neuroflo Catheter
COBE Laboratories Heparinized Arterial Screen Blood Filter
Sentry Smarxt 43 Micron Arterial Filter
Smarxt BMR 1900 Closed Venous Reservoir Bag
Smarxt VVR 4000 Filtered Hardshell Venous Reservoir
Smarxt VVR4000I Plus Filtered Hardshell Venous Reservoir
Smarxt HVR 4000 Surface Modified Hardshell Venous Reservoir
Closed Venous Reservior Bags with Smarxt
Sorin Biomedica Smarxt BCD Vanguard Surface Modified Blood Cardioplegia System
Smarxt Optimin Surface Modified Hollow Fiber Membrane Oxygenator
Smarxt Optima XP Surface Modified Hollow Fiber Membrane Oxygenator
CML Duo with Smarxt Surface Modified Membrane Oxygenator
Smarxt Tubing and Connectors
Cook, Inc Amplatz Heparin Coated Catheter
Cordis BX Velocity with Hepacoat Coronary Stent
Covidien Heparin Flush Solutions
Palindrome Emerald 14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating
14.5 Fr Chronic Hemodialysis Catheter with Heparin Coating and Silver Impregnated Sleeve (Palindrome Sapphire)
Critikon Company, LLC Heparin-Coated Balloon Thermodilution Catheters
Current Technologies Inc. [Arterial Micro Collection Kit]
[Prefilled Arterial Blood Sampling Syring]
Dade Behring, Inc. Dimension Vista System Drugs of Abuse Calibrator
Dade, Baxter Travenol [Heparin Assay]
Daig Corp Heparin Bonding for Cathteters
Datascope Corp Percluder-DL Occluding Balloon Heparin Coated
Diagnostica-Stago [Rotachrom Heparin]
Dupont Medical Products [Dupont Apc Blood Collection Container With Lithiu]
Edwards Lifesciences Embol-X Intra-Aortic Filter
Heparin Coated Arterial Blood Filters
Retrograde Cardioplegia Cannula with Duraflo
PediaSat Oligon Oximetry Catheters with AMC Thromboshield Heparin Coating
PreSep Oligon Oximetry Catheters with AMC Thromboshield Heparin Coating
Polyethylene Central Venous Catheter with Heparin Coating
Swan-Ganz and Edwards Laboratories Heparin Coated Catheters
Edwards Vantex Central Venous Catherer with Thromboshield Coating
Edwards AVA 3Xi Device with Thromboshield Coating
Edwards AVA High-Flow Device with Thromboshield Coating
Edwards IntroFlex Percutaneous Sheath Introducer with Thromboshield Coating
Venous Reservoir Bag Model No. BMR-800 with Heparin
Venous Reservoir /Cardiotomy Autotransfusion Filter
Duraflo II Heparin Oxygenator Model Univox Gold
Univox Gold Membrane Oxygenator with Duraflo
Extracorporeal Circuit with Duraflo II Heparin Treatment
Sarns Centrifugal Pump with Duraflo II Treatment
Jackson-Pratt Gold Wound Drains with Duraflo II
Bentley Quick-Prime Hemoconcentrator with Duraflo Treatment
Electro-Catheter Corp Elecath Heparin-Coated Catheters
Elecath Heparin-Coated Temporary Pacing Catheters
Elecath Heparin-Coated Thermal Dilution Catheters
Em Diagnostics [Easy-Test PTT]
Embol-X, Inc. Embol-X Aortic Filters
Aortic Cannula Metal J-Tip (24 Fr)
Embol-X Aortic Occlusion and Carioplegia Cannula
Embol-X Introducer Model CF00200
Emisphere Technologies, Inc Heparin Flushes
EV3 Spiderfx Embolic Protection Device
Excelsior Medical Heparin Flushes
GISH Biomedical, Inc. GISH Tubing and Connectors with GBS Coating
GISH Arterial Filter with GBS Coating
GISH ATR2900 and CAP35 Series Reservoirs with GBS Coating
V-Bag with GBS Coating
GISH CAPVRF44 Hardshell Venous Reservoir Ba with GBS Coating
Soft Venous Reservoir (SVRXX) with GBS Coating
IBC Flopump with GBS Coating
Vision Blood Cardioplegia System and Extracorporeal Heat Exchanger with GBS Coating
Gould, Inc. Heparin Coated Thermodilution Catheters
Greiner Bio-One [Greiner Vacuette Blood Collection Tube W/Lithium]
[Vacuette Evacuated Blood Collection Tubes]
Greiner Meditech Inc. [Greiner Minicollect Li Heparin Gel]
[Greiner Minicollect Lithium Heparin Gel Blood Col]
Guidant Corp Neurolink System
Helena Laboratories [Chrom Z-Heparin]
[APTT-ES]
Hospira, Inc. Opticath Central Venous Oximtery Probes
Latex-free Advanced Sensor Catheters
Flow-Directed Heparin Coated Thermodilution Catheter
Opticath Catheter
Opticath Heparin Coated Flow Directed Catheter
Oximetrix Flow Directed Thermal Dilution Catheter
Hyphen Biomed [Biophen Heparin 3,6]
Infusaid Corp Heparin Lock Maintenance Kit
Innerdyne, Inc. Innerdyne Radially Expanding Vascular Access System
Instrumentation Laboratory Co Heparinized Flow Directed Thermal Dilution Catheter
[Il Test]
[Coamatic Heparin]
International Technidyne (ITC) [Hemochron Jr]
[Hemochron Kaolin-Activated Heparin]
Intervascular, Inc. Intergard Knitted Collagen Coated and Heparin Bonded Vascular Protheses
Intergard Knitted Ultra-Thin Collagen Coated and Heparin Bonded Vascular Protheses
J-Lloyd Medical, Inc. Flow Direct Thermodilution Balloon Catheter with Heparin Coating
Johnson & Johnson Arterial 20/40 Micron Filters with Heparin Coating
KMA Inc. Heparin Coated Thermodilution Catheter
Maquet Cardiopulmonary AG Jostra Quadrox D Diffusion Membrane Oxygenator with Bioline Coating
Mansfield Scientific Heparin Coated Temporary Pacing Electrode
Martech Medical Products Inc. [Marksman Arterial Blood Gas Syringe]
Medefil, Inc. Heparin Flushes
Medelec Intl. Corp. [Blood Specimen Collection Devices]
Medical Components, Inc MedComp DUO-COAT Catheter Double Lumen
Medrad, Inc. Benzalkonium-Heparin Coated Guidewires
Medtronic Trillium Bio Disposable Blood Flow Probe
Trillium Tri-Optic Measurement Cell
Trillium Affinity NT Cardiotomy Venous Reservoir
Trillium Biopump Plus Model BPX80T
Affinity 20 Micron Arterial Filter with Trillium Biosurface
Affinity 38 Micron Arterial Filter with Trillium Biosurface
Select 3D (and CAP) Arterial Cannula with Carmeda Boactive Surface
Affinity Pediatric Arterial Filter
Affinity NT Hollow Fiber Oxygenator
Trillium Myotherm XP Cardioplegia Delivery System
Tubing and Connectors with Trillium Biopassive Surface
Carmeda or Trillium Coated Myotherm Blood Cardioplegia System
Carmeda Coated Intersept Pediatric Arterial Filter
Minimax/Maxima Hollow Fiber Oxygenators
Minimax Oxygenation System
Mentor Corp Mentor Tissue Expanders with TDMAC Coating
Microbio-Medics Inc. [Microtek Medical`S Blood Collection Kit]
Millenia Healthcare, Corp. Heparin Flushes
Morris innovative Research, Inc. Femoral Introducer Sheath and Hemostasis (FISH) Device 5, 6, and 8 French
Nova Medical Speicialties Heparin Coated Balloon Thermodilution Catheters
Novalung GMBH Novalung Surgical Lung Assist (SLA) Membrane Lung
Organon Teknika [MDA Heparin Anti-X]
Ortho [Synthafax]
Oximetrix Inc. Opticath Heparin Coated Flow Direct Catheter
Pacific Hemostasis [Thromboscreen APTT]
Parke-Davis Co. Deseret Heparin Coated Flow Catheters
Parker Pharmaceutical, Inc. Heparin Flushes
Physician Industries, Inc. PICC Insertion Tray with Hep-LOCK Heparin Flush
Precision Biologicals [APTT Reagent]
Radiant Medical Radiant Medical Endocatheter Temperature Probe
Setpoint Endovascular Temperature Management System
Reprieve Endovascular Termperature Therapy System
Radiometer Medical Aps [Safepico]
Ram Scientific [Safe-T-Fill Capillary Blood Collection System]
Research Industries Corp. Duraflo II Heparin Treated Cannulae
Research Medical. Inc. TDMAC-Heparin Coated RMI Carotid Bypass Shunt
Rocap/Sabratek Corp Heparin Flushes
Roche Diagnostics [Coaguchek]
Safety Diagnostics Inc. [Pinset]
Shapes Heparin Flushes
Shelhigh, Inc Delcol Heparinized Pericardial Substitute
Sherwood Medical Co. Argyle Griffith TDMAC Heparinized Veno-venous Shunt
Heparinized Wound Suction Tubing
Heparinized Saratoga Sump Drain
Heparinized Penrose Tubing
Heparinized Intravenous Cannula
[Lancer Coagent APTT]
[Monoject Sample Capillary Plasma Sep W/Lith Hepar]
[Monoject Samplette Capillary Blood Coll]
[Monojet Sps Blood Collection Tube]
Sigma [APTT Reagent]
Sims Portex Inc. [Pro-Vent Pulsator Arterial Blood Sampling Syring]
Smith's Healthcare Manufacturing Injection Adaptor Heparin Lock
Smiths Industries Medical Systems Inc. [Sims Pro-Vent 250 (500) Plus Arterial Blood Sample]
Smith's Medical ASD Injection Adaptor Heparin Lock
Solo Pak Labs Heparin Flushes
Sorenson Research Flow-Directed Heparin Coated Thermodilution Catheter
Spectramed, Inc. Heparin Coated Luminal Pacing Catheter
Spire Biomedical, Inc. 15.5 Fr Decathalon Coated Catheters
Starplex Scientific Inc. [Vacuplus Tubes With Green Stoppers]
Statspin Technologies [Statspin Statsampler]
Sunscope Intl, Inc. Heparin Coated Thermodilution Catheter and Accessories
Terumo Corp. [Capiject Sys Capillary Blood Collect]
[Venoject Ii Blood Collection Tubes]
Vital Scientific [APTT]
Vital Signs, Inc Heparin Flushes
W.L. Gore & Associates, Inc. Gore Propaten Vascular Graft
Gore Viabahn Endoprosthesis with Heparin Bioactive Surface
Wako Intl. Inc. [Seri-Sep Serum/Plasma Islolator]