CLASS I ONGOING Device recall · Reported 22 May 2024 · FDA Enforcement Report
Expo 5F Selective Angiographic Catheters recalled by Boston Scientific
Boston Scientific is recalling Expo 5F Selective Angiographic Catheters. The recall was initiated on 21 Mar 2024 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1681-2024
- FDA event ID
- 94240
- Recalling firm
- Boston Scientific, Maple Grove, MN
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 21 Mar 2024
- FDA classified
- 10 May 2024
- Reported
- 22 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 21 Mar 2024 | Recall initiated by company | |
| 10 May 2024 | Classified by FDA | +50 days |
| 22 May 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO AR2 (5PK), REF H74908526862; cardiac catheter
Where it was distributed
Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
UDI/DI 08714729168874, Batch Numbers: 60430930, 60447169, 60462004, 60475385, 60515237, 60525060, 60447168, 60461420, 60474038, 60486305, 60522598, 60531431, 60540176
Where was it sold?
Worldwide distribution. US, US Territories, EMEA, Canada, LATAM and Asia Pacific countries/regions.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
47 other products · FDA event 94240This product is part of a recall event; the main page for the event is Expo 5F Selective Angiographic Catheters recalled by Boston Scientific.
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