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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 62278

11 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 11, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Edwards Lifesciences, LLC

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

11 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 11

Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7J. For use in patients who require hemodynamic monitoring.

Z-2188-2012
Recall number
Z-2188-2012
Initiated
May 11, 2012
Classification
Class II
Status
Terminated
Recalling firm
Edwards Lifesciences, LLC
Quantity
32,145 units for all products in Recall Event

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

59243259, 59263146

Distribution pattern

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), Latin America, (Chile, Colombia, Panama, Mexico, and Honduras).

device · product 2 of 11

Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7P. For use in patients who require hemodynamic monitoring.

Z-2189-2012
Recall number
Z-2189-2012
Initiated
May 11, 2012
Classification
Class II
Status
Terminated
Recalling firm
Edwards Lifesciences, LLC
Quantity
32,145 units for all products in Recall Event

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

59194311, 59194312, 59194313, 59197002, 59197003, 59197893, 59197894, 59197895, 59197896, 59203369, 59203370, 59203371, 59203372, 59203373, 59219841, 59219842, 59219844, 59219845, 59224417, 59247409, 59247410, 59247411, 59247413

Distribution pattern

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), Latin America, (Chile, Colombia, Panama, Mexico, and Honduras).

device · product 3 of 11

Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7J. For use in patients who require hemodynamic monitoring.

Z-2190-2012
Recall number
Z-2190-2012
Initiated
May 11, 2012
Classification
Class II
Status
Terminated
Recalling firm
Edwards Lifesciences, LLC
Quantity
32,145 units for all products in Recall Event

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

59174383, 59174384, 59216111, 59219855, 59233891, 59247471, 59252542

Distribution pattern

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), Latin America, (Chile, Colombia, Panama, Mexico, and Honduras).

device · product 4 of 11

Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7P. For use in patients who require hemodynamic monitoring.

Z-2191-2012
Recall number
Z-2191-2012
Initiated
May 11, 2012
Classification
Class II
Status
Terminated
Recalling firm
Edwards Lifesciences, LLC
Quantity
32,145 units for all products in Recall Event

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

59169527, 59169528, 59174318, 59174320, 59194314, 59194315, 59194316, 59194317, 59197004, 59197005, 59197006, 59197007, 59197008, 59197009, 59197010, 59197897, 59197898, 59197899, 59197900, 59197901, 59197902, 59197903, 59203374. 59203375, 59203377, 59203378, 59203379, 59203380, 59203381, 59207074, 59207075, 59207076, 59207077, 59216092, 59216093, 59216094, 59216096, 59216097, 59216098, 59216099, 59219846, 59230687, 59230688, 59230689, 59230690, 59230691, 59230692, 59233882, 59238962, 59238963, 59238964, 59238965, 59243250, 59243249, 59247419, 59247421, 59247420, 59247422, 59247423, 59247424, 59247425, 59247426, 59247427, 59247428, 59247429

Distribution pattern

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), Latin America, (Chile, Colombia, Panama, Mexico, and Honduras).

device · product 5 of 11

Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HVF7P. For use in patients who require hemodynamic monitoring.

Z-2192-2012
Recall number
Z-2192-2012
Initiated
May 11, 2012
Classification
Class II
Status
Terminated
Recalling firm
Edwards Lifesciences, LLC
Quantity
32,145 units for all products in Recall Event

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

59197000, 59197001, 59216091, 59218827, 59238961

Distribution pattern

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), Latin America, (Chile, Colombia, Panama, Mexico, and Honduras).

device · product 6 of 11

Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141F7. For use in patients who require hemodynamic monitoring.

Z-2193-2012
Recall number
Z-2193-2012
Initiated
May 11, 2012
Classification
Class II
Status
Terminated
Recalling firm
Edwards Lifesciences, LLC
Quantity
32,145 units for all products in Recall Event

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

59194300, 59203362, 59216087, 59233785, 59243242

Distribution pattern

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), Latin America, (Chile, Colombia, Panama, Mexico, and Honduras).

device · product 7 of 11

Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7J. For use in patients who require hemodynamic monitoring.

Z-2194-2012
Recall number
Z-2194-2012
Initiated
May 11, 2012
Classification
Class II
Status
Terminated
Recalling firm
Edwards Lifesciences, LLC
Quantity
32,145 units for all products in Recall Event

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

59194334, 59224788, 59239507, 59247472

Distribution pattern

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), Latin America, (Chile, Colombia, Panama, Mexico, and Honduras).

device · product 8 of 11

Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141HF7P. For use in patients who require hemodynamic monitoring.

Z-2195-2012
Recall number
Z-2195-2012
Initiated
May 11, 2012
Classification
Class II
Status
Terminated
Recalling firm
Edwards Lifesciences, LLC
Quantity
32,145 units for all products in Recall Event

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

59174297, 59194298, 59194299, 59197887, 59203360, 59203361, 59207070, 59219837, 59247401, 59247402

Distribution pattern

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), Latin America, (Chile, Colombia, Panama, Mexico, and Honduras).

device · product 9 of 11

Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151F7. For use in patients who require hemodynamic monitoring.

Z-2196-2012
Recall number
Z-2196-2012
Initiated
May 11, 2012
Classification
Class II
Status
Terminated
Recalling firm
Edwards Lifesciences, LLC
Quantity
32,145 units for all products in Recall Event

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

59174304, 59174305, 59174306, 59196997, 59211405, 59211406, 59211407, 59211408, 59216088, 59233788, 59233789, 59253934, 59252521, 59252522, 59252523, 59252524

Distribution pattern

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), Latin America, (Chile, Colombia, Panama, Mexico, and Honduras).

device · product 10 of 11

Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151HF7. For use in patients who require hemodynamic monitoring.

Z-2197-2012
Recall number
Z-2197-2012
Initiated
May 11, 2012
Classification
Class II
Status
Terminated
Recalling firm
Edwards Lifesciences, LLC
Quantity
32,145 units for all products in Recall Event

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

59163071, 59174300, 59178366, 59233787

Distribution pattern

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), Latin America, (Chile, Colombia, Panama, Mexico, and Honduras).

device · product 11 of 11

Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model TS057HF7. For use in patients who require hemodynamic monitoring.

Z-2198-2012
Recall number
Z-2198-2012
Initiated
May 11, 2012
Classification
Class II
Status
Terminated
Recalling firm
Edwards Lifesciences, LLC
Quantity
32,145 units for all products in Recall Event

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

59267057

Distribution pattern

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), Latin America, (Chile, Colombia, Panama, Mexico, and Honduras).