Recall archive / FDA device enforcement
Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 8F ... — FDA record Z-1379-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 14, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 8F (2.7mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum Introducer size 9F (3.0 mm)
- Reason
- There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when connected to patient monitoring device, the monitor may display an error message.
- Classification
- Class II
- Recalling firm
- Edwards Lifesciences, LLC
- Quantity
- 59,094 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1379-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Primary DI Number: 00690103146554/ Lot: 64191420 64228620 64229652 64238028 64238630 64243142 64243143 64260684 64260685 64262168 64264946 64278346 64289390 64289391 64289408 64304361 64304362 64304363 64314476 64314477 64314479 64320628 64325327 64328112 64328113 64328114 64328115 64337979 64337980 64337981 64345011 64345012 64355442 64362238 64362239 64362240 64362241 64362242 64373343 64373344 64373345 64381703 64383275 64383276 64383277 64385609 64385610 64385611 64385612 64385613 64398982 64398983 64398984 64410910 64410911 64410912 64410913 64410914 64423626 64423627 64423628 64423629 64423630 64430338 64430339 64430340 64446892 64446893 64446894 64446895 64458777 64458778 64458779 64462548 64462549 64470780 64470781 64470782 64470783 64478098 64478099 64483100 64483101 64483102 64483103 64483104 64496490 64496491 64514042 64540629 64540630 64540631 64552372 64577637 64578749 64578750 64584948 64584949 64584950 64584951 64584952 64603534 64609691 64613340 64617864 64623071 64636398 64664097 64664390 64742870 64746321 64746322 64762706 64769085 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA RI SC SD TN TX UT VA WA WI WV WY OUS: None
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Apr 19, 2023
- Recall initiation date
- Feb 14, 2023
- Center classification date
- Apr 12, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.