FDA Device recall Z-1668-2024
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085263012
- FDA Device
- Class I
- ongoing
- Published 2024-05-22
On 2024-05-22 the FDA classified a Class I recall of Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085263012 by Boston Scientific, citing 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 delamin….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1668-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-03-21 |
| Published | 2024-05-22 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Boston Scientific |
| Distribution | n/a |
Product
Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO MULTIPACK 145 (5PKX3), REF H749085263012; cardiac catheter
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 the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining.
Identifiers
| code_info | UDI/DI 08714729187875, Batch Numbers: 60422723, 60442593, 60463980, 60477215, 60490182, 60504886, 60422730, 60442594, 6…UDI/DI 08714729187875, Batch Numbers: 60422723, 60442593, 60463980, 60477215, 60490182, 60504886, 60422730, 60442594, 60463981, 60477318, 60496717, 60509543, 60423803, 60449237, 60465461, 60478140, 60498231, 60532101, 60423804, 60452059, 60470647, 60480055, 60500299, 60532102, 60438197, 60453695, 60472578, 60486055, 60500755, 60536194, 60438657, 60456291, 60476246, 60486317, 60500756, 60536195, 60438658, 60459250, 60476454, 60490180, 60500757, 60536196, 60440954, 60463066, 60477214, 60490181, 60502671 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1668-2024%22
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