|
Class 3 Device Recall Cardiac Ablation Percutaneous Catheters |
|
Date Initiated by Firm |
November 28, 2018 |
Create Date |
January 08, 2019 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0699-2019 |
Recall Event ID |
81747 |
PMA Number |
P150005 |
Product Classification |
catheter, percutaneous, cardiac ablation, for treatment of atrial flutter - Product Code OAD
|
Product |
Blazer Open-Irrigated Ablation Batch Catheter
Product Usage: Open Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiological mapping Delivering diagnostic pacing stimuli RF ablation of sustained or recurrent type 1 Atrial Flutter in patients age 18 years or older Treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (PAF) in patients age 18 years or older, when used with a compatible mapping system
|
Code Information |
Blazer Open Irrigated Ablation Catheter Material Number: M00496200, Batch: 20399570, Expiration Date: 3/13/2020 Batch: 21778776, Expiration Date: 2/21/2021 Batch: 22152470, Expiration Date: 5/21/2021 Batch: 22499259, Expiration Date: 8/13/2001 Material Number: M0049620N40 Batch::20413170, Expiration Date: 3/16/2020 Batch: 20809676, Expiration Date: 6/22/2020 Material Number: M0049620K20 Batch: 20403945, Expiration Date: 3/13/2020 |
Recalling Firm/ Manufacturer |
Boston Scientific Corporation 300 Boston Scientific Way Marlborough MA 01752-1291
|
Manufacturer Reason for Recall |
Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These changes resulted in slight variations in resin material compositions which were not reflected in BSC s internal product documentation. Not approved in customer document.
|
FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
On November 28, 2018, Boston Scientific sent Urgent Medical Device Removal - Immediate Action Required letters to their Japanese consignees requesting them to check and segregate any of the recalled product. The letter also asked the consignees to conduct sub-recalls, if necessary, and to return The Reply Verification Tracking Form. |
Quantity in Commerce |
1,282 (all three types in Japan) |
Distribution |
Japan |
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
PMA Database |
PMAs with Product Code = OAD and Original Applicant = Boston Scientific Corp.
|
|
|
|