FDA Medical Device Recalls (openFDA)
Boston Scientific Corporation: AngioJet SOLENT Dista Thrombectomy Set: UPN 111303-001, Catalog No. 111303, Sterilized Using Ethylene Oxide. For breaking apart and removing thrombus from vascular system, used with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits.
- Recall number
- Z-2379-2015
- Recalling firm
- Boston Scientific Corporation
- Product
- AngioJet SOLENT Dista Thrombectomy Set: UPN 111303-001, Catalog No. 111303, Sterilized Using Ethylene Oxide. For breaking apart and removing thrombus from vascular system, used with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits.
- Status
- Terminated
- Initiated
- 2015-07-31
- Posted
- 2015-08-13
- Terminated
- 2016-02-05
- Reason
- AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is Nov-2015, but the units are labeled with a use-by date of Dec-2015.
- Root cause
- Process control
- Action
- Boston Scientific sent an Urgent Medical Device Recall Removal letter dated July 31, 2015, to all affected consignees. The letter described the problem and the affected product. Consignees were advised to segregate the affected product and return it to Boston Scientific. They were also requested consignees to complete and return the Account Reply Verification Tracking Form. Contact your Sales Representative for any questions. For questions regarding this recall call 763-494-1556.
- Quantity
- total of 9 units
- Distribution
- Worldwide Distribution - US including AZ, MO, OH and Internationally to GERMANY and SPAIN.
- Lot, serial or model codes
- 161905
- 510(k) numbers
- ["K113363"]
- PMA numbers
- not on file
- Product code
- DXE
- Firm FEI
- 3002095335
- Firm city
- Maple Grove
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28