Device recall: Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7J. For use in patients who require hemodynamic…
Class II FDA enforcement event 62278. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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.
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Edwards Lifesciences, LLC started this device recall on 11 May 2012. The firm address in the FDA record is in Irvine, CA. FDA put the recall in Class II. FDA event 62278 has 11 product records. The first FDA enforcement report date is 22 Aug 2012. The record gives the status Terminated, with the termination date 17 Jun 2014.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide Distribution-USA (nationwide) and the countries of Canada, Japan, EMEA (Europe, Middle East and Africa), Asia Pacific, (Hong Kong, Indonesia, Malaysia, Australia, and Taiwan, Thailand),…
Recalling firm
Edwards Lifesciences, LLC, Irvine, CA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
11 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2188-2012 | Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7J. For use in patients who require hemodynamic monitoring. | 32,145 units for all products in Recall Event | Class II | Terminated | 22 Aug 2012 |
| Z-2189-2012 | Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7P. For use in patients who require hemodynamic monitoring. | 32,145 units for all products in Recall Event | Class II | Terminated | 22 Aug 2012 |
| Z-2190-2012 | Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7J. For use in patients who require hemodynamic monitoring. | 32,145 units for all products in Recall Event | Class II | Terminated | 22 Aug 2012 |
| Z-2191-2012 | Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7P. For use in patients who require hemodynamic monitoring. | 32,145 units for all products in Recall Event | Class II | Terminated | 22 Aug 2012 |
| Z-2192-2012 | Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HVF7P. For use in patients who require hemodynamic monitoring. | 32,145 units for all products in Recall Event | Class II | Terminated | 22 Aug 2012 |
| Z-2193-2012 | Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141F7. For use in patients who require hemodynamic monitoring. | 32,145 units for all products in Recall Event | Class II | Terminated | 22 Aug 2012 |
| Z-2194-2012 | Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7J. For use in patients who require hemodynamic monitoring. | 32,145 units for all products in Recall Event | Class II | Terminated | 22 Aug 2012 |
| Z-2195-2012 | Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7P. For use in patients who require hemodynamic monitoring. | 32,145 units for all products in Recall Event | Class II | Terminated | 22 Aug 2012 |
| Z-2196-2012 | Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151F7. For use in patients who require hemodynamic monitoring. | 32,145 units for all products in Recall Event | Class II | Terminated | 22 Aug 2012 |
| Z-2197-2012 | Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151HF7. For use in patients who require hemodynamic monitoring. | 32,145 units for all products in Recall Event | Class II | Terminated | 22 Aug 2012 |
| Z-2198-2012 | Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model TS057HF7. For use in patients who require hemodynamic monitoring. | 32,145 units for all products in Recall Event | Class II | Terminated | 22 Aug 2012 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2012
- 823
- Share of these events in Class II
- 88%
- Product records in this event
- 11Median of the firm: 1
- Events of the firm on the register
- 50
Other events of the firm
Official channels
- FDA enforcement report Z-2188-2012The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 62278. https://recallregister.com/fda/ii/62278/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide Distribution-USA (nationwide) and the countries of Canada, Japan, EMEA (Europe, Middle East and Africa), Asia Pacific, (Hong Kong, Indonesia, Malaysia, Australia, and Taiwan, Thailand),…
- What quantity of product is in FDA event 62278?
- The event has 11 product records. The first record gives this quantity:
32,145 units for all products in Recall Event
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2012 have the same class?
- 88% of the 823 device events that started in 2012 are in Class II.