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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84826

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

Open FDA event record

Event summary

Timeline bucket
January 29, 2020
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Abbott Vascular

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

17 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 17

NC TREK Coronary Dilatation Catheter, REF 1012453-08 Rx Only, NC TREK RX 4.00 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only)

Z-1128-2020
Recall number
Z-1128-2020
Initiated
January 29, 2020
Classification
Class I
Status
Terminated
Recalling firm
Abbott Vascular
Quantity
Total 39687 NC TREK units (13891 US and 25796 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

Code information

Device Identifier/GTIN:08717648152054 Part Number: 1012453-08 Lot Numbers: 90731G1 90921G1 90808G1 90928G1 90826G1 91003G1 90906G1 91017G1 91106G1

Distribution pattern

Worldwide Distribution: US (Nation-wide) and OUS (countries of): Algeria Jordan Argentina Korea Armenia Kuwait Aruba Lebanon Australia Malaysia Austria, Mauritius Bahrain Mexico Bangladesh Morocco Belgium Netherlands Brazil New Zealand Brunei Norway Bulgaria Oman Canada Pakistan Chile Panama China Peru Colombia Poland Costa Rica Portugal Croatia R¿union Cyprus Romania Czech Republic Russian Federation Denmark Saudi Arabia Dominican Republic Singapore Egypt Slovakia Estonia Slovenia Finland South Africa France Spain Germany Sri Lanka Greece State of Palestine Hong Kong Sweden Hungary Switzerland Iceland Taiwan, Province of China India Thailand Indonesia Tunisia Iran Turkey Iraq Ukraine Ireland United Arab Emirates Israel United Kingdom Italy Uruguay Japan Viet Nam

device · product 2 of 17

NC TREK Coronary Dilatation Catheter, REF 1012453-12 Rx Only, NC TREK RX 4.00 X 12MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only)

Z-1129-2020
Recall number
Z-1129-2020
Initiated
January 29, 2020
Classification
Class I
Status
Terminated
Recalling firm
Abbott Vascular
Quantity
Total 39687 NC TREK units (13891 US and 25796 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

Code information

Device Identifier/GTIN: 08717648152061 Part Number: 1012453-12 Lot Numbers: 90730G1 90919G1 90731G1 90927G1 90818G1 91001G1 90822G1 91015G1 90905G1 91025G1 90918G1 91101G1

Distribution pattern

Worldwide Distribution: US (Nation-wide) and OUS (countries of): Algeria Jordan Argentina Korea Armenia Kuwait Aruba Lebanon Australia Malaysia Austria, Mauritius Bahrain Mexico Bangladesh Morocco Belgium Netherlands Brazil New Zealand Brunei Norway Bulgaria Oman Canada Pakistan Chile Panama China Peru Colombia Poland Costa Rica Portugal Croatia R¿union Cyprus Romania Czech Republic Russian Federation Denmark Saudi Arabia Dominican Republic Singapore Egypt Slovakia Estonia Slovenia Finland South Africa France Spain Germany Sri Lanka Greece State of Palestine Hong Kong Sweden Hungary Switzerland Iceland Taiwan, Province of China India Thailand Indonesia Tunisia Iran Turkey Iraq Ukraine Ireland United Arab Emirates Israel United Kingdom Italy Uruguay Japan Viet Nam

device · product 3 of 17

NC TREK Coronary Dilatation Catheter, REF 1012453-15 Rx Only, NC TREK RX 4.00 X 15MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only)

Z-1130-2020
Recall number
Z-1130-2020
Initiated
January 29, 2020
Classification
Class I
Status
Terminated
Recalling firm
Abbott Vascular
Quantity
Total 39687 NC TREK (13891 US and 25796 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

Code information

Device Identifier/GTIN: 08717648152078 Part Number: 1012453-15 Lot Numbers: 90815G1 91008G1 90816G1 91009G1 90828G1 91020G1 90904G1 91026G1 90920G1 91109G1 90926G1 91117G1

Distribution pattern

Worldwide Distribution: US (Nation-wide) and OUS (countries of): Algeria Jordan Argentina Korea Armenia Kuwait Aruba Lebanon Australia Malaysia Austria, Mauritius Bahrain Mexico Bangladesh Morocco Belgium Netherlands Brazil New Zealand Brunei Norway Bulgaria Oman Canada Pakistan Chile Panama China Peru Colombia Poland Costa Rica Portugal Croatia R¿union Cyprus Romania Czech Republic Russian Federation Denmark Saudi Arabia Dominican Republic Singapore Egypt Slovakia Estonia Slovenia Finland South Africa France Spain Germany Sri Lanka Greece State of Palestine Hong Kong Sweden Hungary Switzerland Iceland Taiwan, Province of China India Thailand Indonesia Tunisia Iran Turkey Iraq Ukraine Ireland United Arab Emirates Israel United Kingdom Italy Uruguay Japan Viet Nam

device · product 4 of 17

NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.00 X 20MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only)

Z-1131-2020
Recall number
Z-1131-2020
Initiated
January 29, 2020
Classification
Class I
Status
Terminated
Recalling firm
Abbott Vascular
Quantity
Total 39687 NC TREK units (13891 US and 25796 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

Code information

Device Identifier/GTIN: 08717648152085 Part Number: 1012453-20 Lot Numbers: 90727G1 91004G1 90830G1 91028G1 90923G1

Distribution pattern

Worldwide Distribution: US (Nation-wide) and OUS (countries of): Algeria Jordan Argentina Korea Armenia Kuwait Aruba Lebanon Australia Malaysia Austria, Mauritius Bahrain Mexico Bangladesh Morocco Belgium Netherlands Brazil New Zealand Brunei Norway Bulgaria Oman Canada Pakistan Chile Panama China Peru Colombia Poland Costa Rica Portugal Croatia R¿union Cyprus Romania Czech Republic Russian Federation Denmark Saudi Arabia Dominican Republic Singapore Egypt Slovakia Estonia Slovenia Finland South Africa France Spain Germany Sri Lanka Greece State of Palestine Hong Kong Sweden Hungary Switzerland Iceland Taiwan, Province of China India Thailand Indonesia Tunisia Iran Turkey Iraq Ukraine Ireland United Arab Emirates Israel United Kingdom Italy Uruguay Japan Viet Nam

device · product 5 of 17

NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only)

Z-1132-2020
Recall number
Z-1132-2020
Initiated
January 29, 2020
Classification
Class I
Status
Terminated
Recalling firm
Abbott Vascular
Quantity
Total 39687 NC TREK units (13891 US and 25796 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

Code information

Device Identifier/GTIN: 08717648152092 Part Number: 1012454-08 Lot Numbers: 90801G1 90925G1 90812G1 91010G2 90818G1 91022G1 90818G2 91025G1 90904G1 91101G1 90912G1

Distribution pattern

Worldwide Distribution: US (Nation-wide) and OUS (countries of): Algeria Jordan Argentina Korea Armenia Kuwait Aruba Lebanon Australia Malaysia Austria, Mauritius Bahrain Mexico Bangladesh Morocco Belgium Netherlands Brazil New Zealand Brunei Norway Bulgaria Oman Canada Pakistan Chile Panama China Peru Colombia Poland Costa Rica Portugal Croatia R¿union Cyprus Romania Czech Republic Russian Federation Denmark Saudi Arabia Dominican Republic Singapore Egypt Slovakia Estonia Slovenia Finland South Africa France Spain Germany Sri Lanka Greece State of Palestine Hong Kong Sweden Hungary Switzerland Iceland Taiwan, Province of China India Thailand Indonesia Tunisia Iran Turkey Iraq Ukraine Ireland United Arab Emirates Israel United Kingdom Italy Uruguay Japan Viet Nam

device · product 6 of 17

NC TREK Coronary Dilatation Catheter, REF 1012453-20 Rx Only, NC TREK RX 4.50 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only)

Z-1133-2020
Recall number
Z-1133-2020
Initiated
January 29, 2020
Classification
Class I
Status
Terminated
Recalling firm
Abbott Vascular
Quantity
Total 39687 NC TREK units (13891 US and 25796 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

Code information

Device Identifier/GTIN: 08717648152092 Part Number: 1012454-08 Lot Numbers: 90801G1 90925G1 90812G1 91010G2 90818G1 91022G1 90818G2 91025G1 90904G1 91101G1 90912G1

Distribution pattern

Worldwide Distribution: US (Nation-wide) and OUS (countries of): Algeria Jordan Argentina Korea Armenia Kuwait Aruba Lebanon Australia Malaysia Austria, Mauritius Bahrain Mexico Bangladesh Morocco Belgium Netherlands Brazil New Zealand Brunei Norway Bulgaria Oman Canada Pakistan Chile Panama China Peru Colombia Poland Costa Rica Portugal Croatia R¿union Cyprus Romania Czech Republic Russian Federation Denmark Saudi Arabia Dominican Republic Singapore Egypt Slovakia Estonia Slovenia Finland South Africa France Spain Germany Sri Lanka Greece State of Palestine Hong Kong Sweden Hungary Switzerland Iceland Taiwan, Province of China India Thailand Indonesia Tunisia Iran Turkey Iraq Ukraine Ireland United Arab Emirates Israel United Kingdom Italy Uruguay Japan Viet Nam

device · product 7 of 17

NC TREK Coronary Dilatation Catheter, REF 1012454-15 Rx Only, NC TREK RX 4.50 X 15MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only)

Z-1134-2020
Recall number
Z-1134-2020
Initiated
January 29, 2020
Classification
Class I
Status
Terminated
Recalling firm
Abbott Vascular
Quantity
Total 39687 NC TREK units (13891 US and 25796 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

Code information

Device Identifier/GTIN: 08717648152115 Part Number: 1012454-15 Lot Numbers: 90819G1 90927G1 90819G2 90930G1 90916G1 91031G1 90916G2

Distribution pattern

Worldwide Distribution: US (Nation-wide) and OUS (countries of): Algeria Jordan Argentina Korea Armenia Kuwait Aruba Lebanon Australia Malaysia Austria, Mauritius Bahrain Mexico Bangladesh Morocco Belgium Netherlands Brazil New Zealand Brunei Norway Bulgaria Oman Canada Pakistan Chile Panama China Peru Colombia Poland Costa Rica Portugal Croatia R¿union Cyprus Romania Czech Republic Russian Federation Denmark Saudi Arabia Dominican Republic Singapore Egypt Slovakia Estonia Slovenia Finland South Africa France Spain Germany Sri Lanka Greece State of Palestine Hong Kong Sweden Hungary Switzerland Iceland Taiwan, Province of China India Thailand Indonesia Tunisia Iran Turkey Iraq Ukraine Ireland United Arab Emirates Israel United Kingdom Italy Uruguay Japan Viet Nam

device · product 8 of 17

NC TREK Coronary Dilatation Catheter, REF 1012454-20 Rx Only, NC TREK RX 4.50 X 20MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only)

Z-1135-2020
Recall number
Z-1135-2020
Initiated
January 29, 2020
Classification
Class I
Status
Terminated
Recalling firm
Abbott Vascular
Quantity
Total 39687 NC TREK units (13891 US and 25796 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

Code information

Device Identifier/GTIN: 08717648152122 Part Number: 1012454-20 Lot Numbers: 90801G1 91018G1 90809G1 91021G1

Distribution pattern

Worldwide Distribution: US (Nation-wide) and OUS (countries of): Algeria Jordan Argentina Korea Armenia Kuwait Aruba Lebanon Australia Malaysia Austria, Mauritius Bahrain Mexico Bangladesh Morocco Belgium Netherlands Brazil New Zealand Brunei Norway Bulgaria Oman Canada Pakistan Chile Panama China Peru Colombia Poland Costa Rica Portugal Croatia R¿union Cyprus Romania Czech Republic Russian Federation Denmark Saudi Arabia Dominican Republic Singapore Egypt Slovakia Estonia Slovenia Finland South Africa France Spain Germany Sri Lanka Greece State of Palestine Hong Kong Sweden Hungary Switzerland Iceland Taiwan, Province of China India Thailand Indonesia Tunisia Iran Turkey Iraq Ukraine Ireland United Arab Emirates Israel United Kingdom Italy Uruguay Japan Viet Nam

device · product 9 of 17

NC TREK Coronary Dilatation Catheter, REF 1012455-08 Rx Only, NC TREK RX 5.00 X 8MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only)

Z-1136-2020
Recall number
Z-1136-2020
Initiated
January 29, 2020
Classification
Class I
Status
Terminated
Recalling firm
Abbott Vascular
Quantity
Total 39687 NC TREK units (13891 US and 25796 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

Code information

Device Identifier/GTIN: 08717648152139 Part Number: 1012455-08 Lot Numbers: 90918G1 91001G1 90930G1

Distribution pattern

Worldwide Distribution: US (Nation-wide) and OUS (countries of): Algeria Jordan Argentina Korea Armenia Kuwait Aruba Lebanon Australia Malaysia Austria, Mauritius Bahrain Mexico Bangladesh Morocco Belgium Netherlands Brazil New Zealand Brunei Norway Bulgaria Oman Canada Pakistan Chile Panama China Peru Colombia Poland Costa Rica Portugal Croatia R¿union Cyprus Romania Czech Republic Russian Federation Denmark Saudi Arabia Dominican Republic Singapore Egypt Slovakia Estonia Slovenia Finland South Africa France Spain Germany Sri Lanka Greece State of Palestine Hong Kong Sweden Hungary Switzerland Iceland Taiwan, Province of China India Thailand Indonesia Tunisia Iran Turkey Iraq Ukraine Ireland United Arab Emirates Israel United Kingdom Italy Uruguay Japan Viet Nam

device · product 10 of 17

NC TREK Coronary Dilatation Catheter, REF 1012455-12 Rx Only, NC TREK RX 5.00 X 12MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only)

Z-1137-2020
Recall number
Z-1137-2020
Initiated
January 29, 2020
Classification
Class I
Status
Terminated
Recalling firm
Abbott Vascular
Quantity
Total 39687 NC TREK units (13891 US and 25796 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

Code information

Device Identifier/GTIN: 08717648152146 Part Number: 1012455-12 Lot Numbers:90918G1 90930G1 90926G1 91031G1

Distribution pattern

Worldwide Distribution: US (Nation-wide) and OUS (countries of): Algeria Jordan Argentina Korea Armenia Kuwait Aruba Lebanon Australia Malaysia Austria, Mauritius Bahrain Mexico Bangladesh Morocco Belgium Netherlands Brazil New Zealand Brunei Norway Bulgaria Oman Canada Pakistan Chile Panama China Peru Colombia Poland Costa Rica Portugal Croatia R¿union Cyprus Romania Czech Republic Russian Federation Denmark Saudi Arabia Dominican Republic Singapore Egypt Slovakia Estonia Slovenia Finland South Africa France Spain Germany Sri Lanka Greece State of Palestine Hong Kong Sweden Hungary Switzerland Iceland Taiwan, Province of China India Thailand Indonesia Tunisia Iran Turkey Iraq Ukraine Ireland United Arab Emirates Israel United Kingdom Italy Uruguay Japan Viet Nam

device · product 11 of 17

NC TREK Coronary Dilatation Catheter, REF 1012455-15 Rx Only,NC TREK RX 5.00 X 15MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only)

Z-1138-2020
Recall number
Z-1138-2020
Initiated
January 29, 2020
Classification
Class I
Status
Terminated
Recalling firm
Abbott Vascular
Quantity
Total 39687 NC TREK units (13891 US and 25796 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

Code information

Device Identifier/GTIN: 08717648152153 Part Number: 1012455-15 Lot Numbers:90806G1 91022G1 90806G2 91025G1

Distribution pattern

Worldwide Distribution: US (Nation-wide) and OUS (countries of): Algeria Jordan Argentina Korea Armenia Kuwait Aruba Lebanon Australia Malaysia Austria, Mauritius Bahrain Mexico Bangladesh Morocco Belgium Netherlands Brazil New Zealand Brunei Norway Bulgaria Oman Canada Pakistan Chile Panama China Peru Colombia Poland Costa Rica Portugal Croatia R¿union Cyprus Romania Czech Republic Russian Federation Denmark Saudi Arabia Dominican Republic Singapore Egypt Slovakia Estonia Slovenia Finland South Africa France Spain Germany Sri Lanka Greece State of Palestine Hong Kong Sweden Hungary Switzerland Iceland Taiwan, Province of China India Thailand Indonesia Tunisia Iran Turkey Iraq Ukraine Ireland United Arab Emirates Israel United Kingdom Italy Uruguay Japan Viet Nam

device · product 12 of 17

NC TREK Coronary Dilatation Catheter, REF 1012455-120 Rx Only,NC TREK RX 5.00 X 20MM BDC The NC TREK RX Coronary Dilatation Catheter is indicated for: a) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion b) balloon dilatation of a coronary artery occlusion, for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction c) balloon dilatation of a stent after implantation (balloon models 2.00 mm 5.00 mm only)

Z-1139-2020
Recall number
Z-1139-2020
Initiated
January 29, 2020
Classification
Class I
Status
Terminated
Recalling firm
Abbott Vascular
Quantity
Total 39687 NC TREK units (13891 US and 25796 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

Code information

Device Identifier/GTIN: 08717648152160 Part Number: 1012455-20 Lot Numbers:91010G1 91026G1

Distribution pattern

Worldwide Distribution: US (Nation-wide) and OUS (countries of): Algeria Jordan Argentina Korea Armenia Kuwait Aruba Lebanon Australia Malaysia Austria, Mauritius Bahrain Mexico Bangladesh Morocco Belgium Netherlands Brazil New Zealand Brunei Norway Bulgaria Oman Canada Pakistan Chile Panama China Peru Colombia Poland Costa Rica Portugal Croatia R¿union Cyprus Romania Czech Republic Russian Federation Denmark Saudi Arabia Dominican Republic Singapore Egypt Slovakia Estonia Slovenia Finland South Africa France Spain Germany Sri Lanka Greece State of Palestine Hong Kong Sweden Hungary Switzerland Iceland Taiwan, Province of China India Thailand Indonesia Tunisia Iran Turkey Iraq Ukraine Ireland United Arab Emirates Israel United Kingdom Italy Uruguay Japan Viet Nam

device · product 13 of 17

NC TRAVELER Coronary Dilatation Catheter, REF 1013157-08, Rx Only,NC Traveler RX 4.0 X 8MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.

Z-1140-2020
Recall number
Z-1140-2020
Initiated
January 29, 2020
Classification
Class I
Status
Terminated
Recalling firm
Abbott Vascular
Quantity
Total 791 Traveler (0 US and 791 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

Code information

Device Identifier/GTIN: 08717648195983 Part Number: 1013157-08 Lot Numbers:91010G1

Distribution pattern

Worldwide Distribution: US (Nation-wide) and OUS (countries of): Algeria Jordan Argentina Korea Armenia Kuwait Aruba Lebanon Australia Malaysia Austria, Mauritius Bahrain Mexico Bangladesh Morocco Belgium Netherlands Brazil New Zealand Brunei Norway Bulgaria Oman Canada Pakistan Chile Panama China Peru Colombia Poland Costa Rica Portugal Croatia R¿union Cyprus Romania Czech Republic Russian Federation Denmark Saudi Arabia Dominican Republic Singapore Egypt Slovakia Estonia Slovenia Finland South Africa France Spain Germany Sri Lanka Greece State of Palestine Hong Kong Sweden Hungary Switzerland Iceland Taiwan, Province of China India Thailand Indonesia Tunisia Iran Turkey Iraq Ukraine Ireland United Arab Emirates Israel United Kingdom Italy Uruguay Japan Viet Nam

device · product 14 of 17

NC TRAVELER Coronary Dilatation Catheter, REF 1013157-12, Rx Only,NC Traveler RX 4.0 X 12MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.

Z-1141-2020
Recall number
Z-1141-2020
Initiated
January 29, 2020
Classification
Class I
Status
Terminated
Recalling firm
Abbott Vascular
Quantity
Total 791 Traveler (0 US and 791 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

Code information

Device Identifier/GTIN: 08717648195990 Part Number: 1013157-12 Lot Numbers:90812G1

Distribution pattern

Worldwide Distribution: US (Nation-wide) and OUS (countries of): Algeria Jordan Argentina Korea Armenia Kuwait Aruba Lebanon Australia Malaysia Austria, Mauritius Bahrain Mexico Bangladesh Morocco Belgium Netherlands Brazil New Zealand Brunei Norway Bulgaria Oman Canada Pakistan Chile Panama China Peru Colombia Poland Costa Rica Portugal Croatia R¿union Cyprus Romania Czech Republic Russian Federation Denmark Saudi Arabia Dominican Republic Singapore Egypt Slovakia Estonia Slovenia Finland South Africa France Spain Germany Sri Lanka Greece State of Palestine Hong Kong Sweden Hungary Switzerland Iceland Taiwan, Province of China India Thailand Indonesia Tunisia Iran Turkey Iraq Ukraine Ireland United Arab Emirates Israel United Kingdom Italy Uruguay Japan Viet Nam

device · product 15 of 17

NC TRAVELER Coronary Dilatation Catheter, REF 1013157-15, Rx Only,NC Traveler RX 4.0 X 15MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.

Z-1142-2020
Recall number
Z-1142-2020
Initiated
January 29, 2020
Classification
Class I
Status
Terminated
Recalling firm
Abbott Vascular
Quantity
Total 791 Traveler (0 US and 791 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

Code information

Device Identifier/GTIN: 08717648196003 Part Number: 1013157-15 Lot Numbers:91102G1

Distribution pattern

Worldwide Distribution: US (Nation-wide) and OUS (countries of): Algeria Jordan Argentina Korea Armenia Kuwait Aruba Lebanon Australia Malaysia Austria, Mauritius Bahrain Mexico Bangladesh Morocco Belgium Netherlands Brazil New Zealand Brunei Norway Bulgaria Oman Canada Pakistan Chile Panama China Peru Colombia Poland Costa Rica Portugal Croatia R¿union Cyprus Romania Czech Republic Russian Federation Denmark Saudi Arabia Dominican Republic Singapore Egypt Slovakia Estonia Slovenia Finland South Africa France Spain Germany Sri Lanka Greece State of Palestine Hong Kong Sweden Hungary Switzerland Iceland Taiwan, Province of China India Thailand Indonesia Tunisia Iran Turkey Iraq Ukraine Ireland United Arab Emirates Israel United Kingdom Italy Uruguay Japan Viet Nam

device · product 16 of 17

NC TRAVELER Coronary Dilatation Catheter, REF 1013158-08, Rx Only,NC Traveler RX 4.5 X 8MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.

Z-1143-2020
Recall number
Z-1143-2020
Initiated
January 29, 2020
Classification
Class I
Status
Terminated
Recalling firm
Abbott Vascular
Quantity
Total 791 Traveler (0 US and 791 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

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Reason for recall

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

Code information

Device Identifier/GTIN: 08717648196027 Part Number: 1013158-08 Lot Numbers:90812G1

Distribution pattern

Worldwide Distribution: US (Nation-wide) and OUS (countries of): Algeria Jordan Argentina Korea Armenia Kuwait Aruba Lebanon Australia Malaysia Austria, Mauritius Bahrain Mexico Bangladesh Morocco Belgium Netherlands Brazil New Zealand Brunei Norway Bulgaria Oman Canada Pakistan Chile Panama China Peru Colombia Poland Costa Rica Portugal Croatia R¿union Cyprus Romania Czech Republic Russian Federation Denmark Saudi Arabia Dominican Republic Singapore Egypt Slovakia Estonia Slovenia Finland South Africa France Spain Germany Sri Lanka Greece State of Palestine Hong Kong Sweden Hungary Switzerland Iceland Taiwan, Province of China India Thailand Indonesia Tunisia Iran Turkey Iraq Ukraine Ireland United Arab Emirates Israel United Kingdom Italy Uruguay Japan Viet Nam

device · product 17 of 17

NC TRAVELER Coronary Dilatation Catheter, REF 1013158-12, Rx Only,NC Traveler RX 4.5 X 12MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.

Z-1144-2020
Recall number
Z-1144-2020
Initiated
January 29, 2020
Classification
Class I
Status
Terminated
Recalling firm
Abbott Vascular
Quantity
Total 791 Traveler (0 US and 791 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.

Code information

Device Identifier/GTIN: 08717648196034 Part Number: 1013158-12 Lot Numbers:90813G1

Distribution pattern

Worldwide Distribution: US (Nation-wide) and OUS (countries of): Algeria Jordan Argentina Korea Armenia Kuwait Aruba Lebanon Australia Malaysia Austria, Mauritius Bahrain Mexico Bangladesh Morocco Belgium Netherlands Brazil New Zealand Brunei Norway Bulgaria Oman Canada Pakistan Chile Panama China Peru Colombia Poland Costa Rica Portugal Croatia R¿union Cyprus Romania Czech Republic Russian Federation Denmark Saudi Arabia Dominican Republic Singapore Egypt Slovakia Estonia Slovenia Finland South Africa France Spain Germany Sri Lanka Greece State of Palestine Hong Kong Sweden Hungary Switzerland Iceland Taiwan, Province of China India Thailand Indonesia Tunisia Iran Turkey Iraq Ukraine Ireland United Arab Emirates Israel United Kingdom Italy Uruguay Japan Viet Nam