Date Initiated by Firm | December 07, 2018 |
Create Date | November 26, 2019 |
Recall Status1 |
Terminated 3 on October 27, 2020 |
Recall Number | Z-0576-2020 |
Recall Event ID |
84057 |
PMA Number | P050018 |
Product Classification |
Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring - Product Code NWX
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Product | 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. |
Code Information |
AngioSculpt PTCA lot #G18090030. |
Recalling Firm/ Manufacturer |
Spectranetics Corporation 5055 Brandin Ct Fremont CA 94538-3140
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For Additional Information Contact | Ms. Lauren Vitelli 510-933-7900 |
Manufacturer Reason for Recall | The incorrect outer carton box was used for the product. |
FDA Determined Cause 2 | 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 in Commerce | 3 catheters |
Distribution | Distribution was made to IA, MI, and NJ. There was government distribution. There was no military/foreign distribution. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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PMA Database | PMAs with Product Code = NWX
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