Z-1390-2024Class II

Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the...

Name: Z-1390-2024 Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the...
Creator: Boston Scientific Corporation
Published: 2024-02-20
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2024-02-20 / Open, Classified / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system on 2024-02-20. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1390-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-20
Posted: 2024-03-28
Recalling firm: Boston Scientific Corporation
Product: Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system
Product code: DYB Introducer, Catheter
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Boston Scientific issued an Urgent Field Safety Notice - Medical Device Product Removal to its consignees on 02/20/2027 via FedEx. The notice explained the problem with the device, potential risk, and requested the following: 1. Immediately discontinue use and segregate the affected product. 2. Complete and return the RVTF to get a Return Goods Authorization (RGA) number. 3. Once Boston Scientific receives your completed RVTF, you will be contacted within 2 business days and provided an RGA number for product return. For questions, contact your local Boston Scientific representative.
Quantity in commerce: 4060 devices
Distribution: Worldwide distribution - US Nationwide and the countries of Canada.
Product codes and lots: 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, 32452794, 32461848, 32461849, 32461850, 32470848, 32470849, 32480089, 32480090, 32481344, 32481345, 32522178, 32530450, 32530451, 32602892, 32602893, 32611557, 32611558, 32611559, 32620708, 32620709, 32620710, 32629426, 32642560, 32642561

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1390-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1390-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-03	2024-03-28

Product code DYB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)