—#169711

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

FDA product code: OAD — Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
Device class: Class 3
Medical specialty: Unknown
PMA numbers: P150005
Affected lot / code info: 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

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Boston Scientific Corporation
Address: 300 Boston Scientific Way, Marlborough, Massachusetts 01752-1291

Distribution

Distribution pattern: Japan

Timeline

Recall initiated: 2018-11-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #169711. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.