Recall Z-2039-2017
Abbott Vascular · initiated March 22, 2017
Class I – dangerous or defective products that could cause serious health problems or death
Product
NC Tenku RX PTCA Balloon Catheter, Part No. 1012448-08T, 1012448-12T, 1012448-15T, 1012449-08T, 1012449-12T, 1012449-15T, 1012450-08T, 1012450-12T, 1012450-15T, 1012451-08T, 1012451-12T, 1012451-15T, 1012452-08T, 1012452-12T, 1012452-15T, 1012453-08T, 1012453-12T
Codes / lots: Lot Number 60202G1 60301G1 60502G1 60301G1 60401G1 61101G1 60202G1 60401G1 60601G1 60801G1 61101G1 60302G1 60401G1 60601G1 60801G1 60202G1 60401G1 60502G1 60601G1 60701G1 60902G1 61004G1 61101G1 60202G1 60301G1 60401G1 60502G1 60601G1 60701G1 60801G1 60902G1 61101G1 60401G1 60601G1 60801G1 60301G1 60701G1 60301G1 60502G1 60701G1 60301G1 60502G1 60701G1 60902G1 60301G1 60502G1 60701G1 61004G1 60301G1 60401G1 60601G1 60701G1 60805G1 61004G1 50204G1 50406G1 50202G1 50901G1 50204G1 60202G1 60502G1 60701G1 61101G1 60202G1 60506G1
Reason for recall
Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the balloon.
FDA-determined cause: Device Design
Action taken
An Urgent Field Safety Notice dated 3/22/17 was sent to customers to inform them that Abbott Vascular is recalling the NC Trek RX Coronary Dilation Catheter, NC Traveler RX Coronary Dilatation Catheter, and NC Tenku RX PCTA Balloon Catheter. Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the balloon. The letter informs the customers of how does the issue occur and what action is Abbott Vascular asking the customers to take. Customers with any questions are instructed to contact local Abbott Vascular Representative or Customer Service Department at (800) 227-9902. On 5/15/17, Abbott Vascular posted a press release on their website to inform customers that Abbott has initiated a voluntary recall of specific lots of three catheters: NC Trek RX Coronary Dilatation Catheter, NC Traveler Coronary Dilatation Catheter, and NC Tenku RX PTCA Balloon Catheter. Products from the identified lots may exhibit difficulty in removing the protective balloon sheath, which could cause problems with inflating or deflating the balloon. Potential risks associated with balloon inflation and deflation difficulties include air embolism, additional intervention, thrombosis, and myocardial infarction.
Details
- Recall number
- Z-2039-2017
- Initiated
- March 22, 2017
- Posted by FDA
- May 12, 2017
- Terminated
- February 7, 2018
- Product code
- LOX – Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Quantity
- 449,661 units total (132,040 units in US)
- Distribution
- US and Worldwide
- Recalling firm
- Abbott Vascular, Temecula, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2037-2017 Class I | NC Trek RX Coronary Dilatation Catheter, Part No. 1012448-06, 1012448-08, 1012448-12…Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can… | 03/22/2017Terminated |
| Z-2038-2017 Class I | NC Traveler RX Coronary Dilatation Catheter, Part No. 1013152-12, 1013152-15…Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can… | 03/22/2017Terminated |