| Date Initiated by Firm |
November 28, 2018 |
| Create Date |
January 08, 2019 |
| Recall Status1 |
Open3, Classified |
| Recall Number |
Z-0700-2019 |
| Recall Event ID |
81747 |
| PMA Number |
P150005S005 |
| Product Classification |
catheter, percutaneous, cardiac ablation, for treatment of atrial flutter - Product Code OAD
|
| Product |
IntellaTip MiFi Open-Irrigated Ablation 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 |
IntellaTip MiFi Open-Irrigated Ablation Catheter Material Number: M004PM96200 Batch: 20368736 Expiration Date: 3/5/2020 Batch: 20531648 Expiration Date: 4/16/2020 Batch: 20560477 Expiration Date: 4/23/2020 Batch: 20566637 Expiration Date: 4/24/2020 Batch: 20628704 Expiration Date: 5/9/2020 Batch: 20628705 Expiration Date: 5/10/2020 Batch: 20763900 Expiration Date: 6/12/2020 Batch: 20769113 Expiration Date: 6/13/2020 Batch: 21318000 Expiration Date: 10/29/2020 Batch: 21318001 Expiration Date: 10/29/2020 Batch: 21357647 Expiration Date: 11/10/2020 Batch: 21463186 Expiration Date: 12/3/2020 Batch: 21543193 Expiration Date: 12/20/2020 Batch: 21574774 Expiration Date: 1/4/2021 Batch: 22195929 Expiration Date: 5/31/2021 Batch: 22202991 Expiration Date: 6/3/2021 Batch: 22290601 Expiration Date: 6/3/2021 Batch: 22305067 Expiration Date: 6/25/2021 Batch: 22315782 Expiration Date: 6/27/2021 Batch: 22317356 Expiration Date: 6/28/2021 Batch: 22327178 Expiration Date: 7/1/2021 Batch: 22329367 Expiration Date: 7/2/2021 Batch: 22330626 Expiration Date: 7/2/2021 Batch: 22371866 Expiration Date: 7/12/2021 Batch: 22371868 Expiration Date: 7/12/2021 Batch: 22379905 Expiration Date: 7/15/2021 Batch: 22435929 Expiration Date: 7/26/2021 Batch: 22435930 Expiration Date: 7/26/2021 Batch: 22438118 Expiration Date: 7/27/2021 Batch: 22455198 Expiration Date: 7/31/2021 Batch: 22499957 Expiration Date: 8/10/2021 Material Number: M004PM9620K20 Batch: 20371559 Expiration Date: 3/6/2020 Batch: 20542305 Expiration Date: 4/18/2020 Batch: 20548241 Expiration Date: 4/19/2020 Batch: 20639975 Expiration Date: 5/14/2020 Batch: 20677314 Expiration Date: 5/21/2020 Batch: 20772834 Expiration Date: 6/14/2020 Batch: 22321772 Expiration Date: 6/29/2021 Batch: 22326857 Expiration Date: 7/1/2021 Material Number: M004PM9620N40 Batch: 20371742 Expiration Date: 3/8/2020 Batch: 20463744 Expiration Date: 3/28/2020 Batch: 20622763 Expiration Date: 5/8/2020 Batch: 20775597 Expiration Date: 6/14/2020 Batch: 22340824 Expiration Date: 7/4/2021 Batch: 22371871 Expiration Date: 7/12/2021 Batch: 22374909 Expiration Date: 7/13/2021 |
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.
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