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Terminated

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)

FDA Recall Z-1128-2020 · Posted 2020-02-14

Recalling FirmAbbott Vascular
Recall StatusTerminated
Product CodeLOX
Date Initiated2020-01-29
Date Terminated2024-04-16
Product QuantityTotal 39687 NC TREK units (13891 US and 25796 OUS)

Reason for Recall

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

Firm Action

On 01/29/2020, the firm field personnel and Affiliates directly contacted the first customers beyond the firm's control via phone, email, or personal visit to facilitate rapid notification. The "URGENT MEDICAL DEVICE RECALL" Notification informed customers that specific lots of its Coronary Dilatation Catheters with diameters of 4.0 mm, 4.5 mm, and 5.0 mm may exhibit difficulty or inability to deflate the balloon due to weaker material proximal to the balloon bond resulting from excess heat exposure during manufacturing, and the potential risks with the use of the affected products include air embolism, thrombosis, myocardial infarction and additional intervention. Healthcare Professionals will be instructed to: " Reference the attached list of affected part numbers and lot numbers " Immediately stop using affected devices from these lots " Review your inventory, complete and return the attached Effectiveness Check Form " Return all unused affected product to Abbott " Share this notification with other relevant personnel in their organization The action the Recalling Firm is taking: * Stopped shipping affected lots * Will implement appropriate corrective actions to ensure product performance * Field Representatives can assist in identifying and returning affected devices * Will work with customers to replace returned units with similar devices, pending availability. For any questions, contact Customer Service Department at (800) 227-9902.

Root Cause

Process change control

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K110134NC TREK RX CORONARY DILATATION CATHETERAbbott Vascular-Cardiac Therapies · 2011-02-11K103153VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION CATHETERAbbott Vascular-Cardiac Therapies · 2010-12-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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