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U.S. Department of Health and Human Services

Class 2 Device Recall Spectranetics AngioSculpt PTCA Scoring Balloon Catheter

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  Class 2 Device Recall Spectranetics AngioSculpt PTCA Scoring Balloon Catheter see related information
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
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
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
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.
PMA Database PMAs with Product Code = NWX and Original Applicant = SPECTRANETICS CORP.
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