Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160
Summary
The FDA issued a Class I for Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS216 by Boston Scientific Corporation. Reason: Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistu.
Details
Source
Device Recall
External ID
Z-0302-2025
Action Date
2024-11-20
Status
Ongoing
Category
device
Product Description
Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160
Lot/Code Info: GTIN 00191506016463
Quantity Affected: 368 units
Reason for Recall
Boston Scientific is updating the instructions for use of their POLARx and POLARx FIT Cryoablation Balloon Catheters related to Atrio-esophageal Fistula Risk.
Distribution
Worldwide
Type: Voluntary: Firm initiated
Recall Initiated: 2024-10-10
Company
Saint Paul, MN
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 242 device recalls issued in the same week, part of 413 device-related FDA actions this month.
Boston Scientific Corporation has 399 FDA actions in our database, including 334 recalls and 65 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Boston Scientific Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Boston Scientific Corporation have FDA actions?
Boston Scientific Corporation has 399 FDA actions in our database, including 334 recalls and 65 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0302-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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