Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL6 (5PK), REF H74908526252; cardiac catheter
Summary
The FDA issued a Class I for Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL6 (5PK), REF H749085 by Boston Scientific Corporation. Reason: An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of t.
Details
Source
Device Recall
External ID
Z-1662-2024
Action Date
2024-05-22
Status
Ongoing
Category
device
Product Description
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL6 (5PK), REF H74908526252; cardiac catheter
Lot/Code Info: UDI/DI 08714729187851, Batch Numbers: 60447163, 60464498, 60485991, 60515607, 60517314, 60533583
Quantity Affected: 1669 catheters
Reason for Recall
An increase in complaints related to an inability to advance the guidewire through the lumen of the device for certain batches. There is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Distribution
Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-21
Company
Maple Grove, 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 191 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-1662-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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