Key facts
| Recalling firm | Boston Scientific Corporation |
|---|---|
| Manufacturer | Not disclosed in the FDA record. |
| Brand name | Not disclosed in the FDA record. |
| Product description | Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 (5PK), REF H7490852624; cardiac catheter |
| Classification | Class I |
| Recall number | Z-1685-2024 |
| Report date | Not disclosed in the FDA record. |
| Status | Ongoing |
| 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. |
What consumers should do
Facilities, clinicians, and consumers holding an affected unit or lot of Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 (5PK), REF H7490852624; cardiac catheter should stop using it for the purpose described in the recall notice and hold remaining stock pending instructions from Boston Scientific Corporation. FDA recall records typically direct the recalling firm to notify known accounts directly with a recall letter describing the specific corrective action -- replacement, field correction, refund, or return. Anyone who received the product through a distributor rather than directly from Boston Scientific Corporation should confirm with their supplier whether their specific lot or unit is on the affected list, since recall notices are lot- or unit-specific and not every unit of a product line is necessarily included. Questions about a specific unit's status should go to Boston Scientific Corporation directly or to the distributor that supplied it; Argus HQ is a public-record aggregator, not the recalling firm, and cannot confirm individual unit status.
What this classification means
A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case -- it reflects FDA’s assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field. FDA's Center for Devices and Radiological Health (for devices) or Center for Drug Evaluation and Research (for drugs) reviews the classification and can require additional corrective action if the initial response is judged insufficient. Because this record is filed as Class I, professionals and consumers handling an affected lot should treat FDA's own classification -- not this page's summary of it -- as the authoritative risk signal. A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death. This classification does not mean harm has already occurred in every case -- it reflects FDA’s assessment of the realistic worst-case risk profile of the defect described in the recall, based on the reason for recall reported by the firm. Class I recalls receive the closest FDA monitoring of the three classes: the recalling firm typically must submit a recall strategy, periodic status reports, and effectiveness checks confirming that the affected lots have actually been removed from distribution or corrected in the field.
Boston Scientific Corporation’s FDA history
Argus HQ has recorded 272 total FDA actions tied to Boston Scientific Corporation: 0 warning letters, 272 recalls, 0 approval records, and 0 Form 483 inspection citations.
Frequently asked questions
- What is the current status of this recall?
- Status as recorded by FDA: Ongoing.
- Where can I verify this recall directly with FDA?
- The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.
- Is Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL recalled?
- Yes. FDA lists a Class I recall by Boston Scientific Corporation for Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL5 (5PK), REF H7490852624; cardiac catheter, reported 20240522, with status "Ongoing." FDA recall number: Z-1685-2024.
- What is the recall class for Boston Scientific Corporation's recall?
- FDA classified this recall as Class I. A Class I recall is FDA’s most serious classification. FDA assigns Class I when there is a reasonable probability that use of, or exposure to, the recalled product will cause serious adverse health consequences or death.
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Related enforcement actions
Full FDA history for Boston Scientific Corporation- Recall: Boston Scientific Corporation — Class II recall: CRE Pro Wireguided 8-10mm 240cm →
- Recall: Boston Scientific Corporation — Class II recall: CRE Wireguided 15-18mm 240cm →
- Recall: Boston Scientific Corporation — Class II recall: CRE Wireguided 10-12mm 240cm →
- Recall: Boston Scientific Corporation — Class II recall: CRE Pro Wireguided 6-8mm 240cm →
- Recall: Boston Scientific Corporation — Class II recall: CRE Wireguided 6-8mm 240cm →
- Recall: Boston Scientific Corporation — Class II recall: CRE Wireguided 18-20mm 240cm →
- Recall: Boston Scientific Corporation — Class II recall: CRE Pro Wireguided 15-18mm 240cm →
- Recall: Boston Scientific Corporation — Class II recall: CRE Pro Wireguided 12-15mm 240cm →
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2024). Recall Record: Class I Recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F… by Boston Scientific Corporation. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/recall/boston-scientific-corporation-z-1685-2024-2024-05-22
"Recall Record: Class I Recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F… by Boston Scientific Corporation." Argus HQ Research, Digital Empire Holdings LLC, 2024, argushq.ai/recall/boston-scientific-corporation-z-1685-2024-2024-05-22.
Argus HQ Research. "Recall Record: Class I Recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F… by Boston Scientific Corporation." Digital Empire Holdings LLC. Accessed July 24, 2026. https://argushq.ai/recall/boston-scientific-corporation-z-1685-2024-2024-05-22.
@misc{argushq_argushq_ai_recall_boston_scientific_corporation_z_1685_2024_2024_05_22_2024,
title = {Recall Record: Class I Recall: Expo 5F Selective Angiographic Catheters, MODEL - 5F… by Boston Scientific Corporation},
author = {{Argus HQ Research}},
year = {2024},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/recall/boston-scientific-corporation-z-1685-2024-2024-05-22},
note = {Accessed: July 24, 2026}
}Source: FDA.gov — Recalls ↗