Recall Z-0576-2020 ยท NWX Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring
Spectranetics Corporation
Spectranetics AngioSculpt PTCA Scoring Balloon Catheter, balloon outer diameter 2.5mm, balloon length 15mm, REF 2027-2515, Sterile, Rx. The firm name on the label is Spectranetics Corporation, Fremont, CA.
| Date | Dec 7, 2018 |
| Status | Terminated |
| Reason | The incorrect outer carton box was used for the product. |
| Root cause | Process control |
| Action | The recalling firm issued an undated Dear Healthcare Professional letter via FedEx informing the consignee of the issue, the risk to health, and the actions to be taken. Return of the device was requested. |
| Quantity | 3 catheters |
| Distribution | Distribution was made to IA, MI, and NJ. There was government distribution. There was no military/foreign distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.