FDA Device recall Z-1390-2024
Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system
- FDA Device
- Class II
- ongoing
- Published 2024-04-03
On 2024-04-03 the FDA classified a Class II recall of Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system by Boston Scientific, citing boston Scientific is conducting a removal of specific batches of the iSLEEVETM 14F Expandable Introducer Set due to complaints associated with a hemostatic valve leak.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1390-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-02-20 |
| Published | 2024-04-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Boston Scientific |
| Distribution | US |
Product
Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system
Reason
Boston Scientific is conducting a removal of specific batches of the iSLEEVETM 14F Expandable Introducer Set due to complaints associated with a hemostatic valve leak.
Identifiers
| code_info | GTIN 08714729950660, Batch Numbers: 31368041, 31390084, 31390088, 31390089, 31501866, 31501867, 31501868, 31501869, 3…GTIN 08714729950660, Batch Numbers: 31368041, 31390084, 31390088, 31390089, 31501866, 31501867, 31501868, 31501869, 31520897, 31520898, 31604492, 31616143, 31633635, 31650457, 31664216, 31664217, 31671140, 31671143, 31693638, 31693639, 31724952, 31732930, 31732931, 31740806, 31740807, 31740808, 31751118, 31777134, 31786582, 31786583, 31818290, 31818299, 31818341, 31818342, 31818343, 31818344, 31818345, 31818346, 31818347, 31838684, 31838685, 31838686, 31838687, 31838688, 31838689, 31877302, 31877304, 31877305, 31877306, 31904748, 31904749, 31923755, 31923756, 31953345, 31953348, 32008170, 32031191, 32031192, 32031193, 32031196, 32059171, 32059386, 32059387, 32059388, 32059392, 32059393, 32059394, 32059396, 32059397, 32212151, 32212153, 32230544, 32230545, 32230546, 32230547, 32230548, 32230549, 32230550, 32230551, 32284196, 32284198, 32284200, 32304326, 32304327, 32304328, 32313757, 32313758, 32313759, 32322405, 32322406, 32322407, 32331162, 32331163, 32331164, 32331165, 32427040, 32 |
|---|
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-1390-2024%22
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