NC TREK Coronary Dilatation Catheter, REF 1012455-120 Rx Only,NC TREK RX 5.00 X 20MM BDC The NC TREK RX Coronary Dilatat
FDA device recall Z-1139-2020 · posted 2020-02-14 · Terminated
Recall details
- Recalling firm
- Abbott Vascular
- Reason for recall
- Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
- Action taken
- 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
- Status
- Terminated
- Product code
- LOX
- Quantity affected
- Total 39687 NC TREK units (13891 US and 25796 OUS)
- Distribution
- 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 Bel
- Date initiated
- 2020-01-29
- Date posted
- 2020-02-14
- Date terminated
- 2024-04-16
- Location
- Temecula, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NC TREK RX CORONARY DILATATION CATHETER (K110134) | Abbott Vascular-Cardiac Therapies | 2011-02-11 |
| VOYAGER NC CORONARY DILATATION CATHETER AND NC TREK RX CORONARY DILATATION CATHETER (K103153) | Abbott Vascular-Cardiac Therapies | 2010-12-30 |