Z-2377-2015Class II

AngioJet Spiroflex Thrombectomy Set: Peripheral - UPN 106553-004, Catalog No.106553, Sterilized Using...

Name: Z-2377-2015 AngioJet Spiroflex Thrombectomy Set: Peripheral - UPN 106553-004, Catalog No.106553, Sterilized Using...
Creator: Boston Scientific Corporation
Published: 2015-07-31
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2015-07-31 / Terminated / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of AngioJet Spiroflex Thrombectomy Set: Peripheral - UPN 106553-004, Catalog No.106553, Sterilized Using Ethylene Oxide. For breaking apart and removing thrombus... on 2015-07-31. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2377-2015
Classification: Class II
Status: Terminated
Initiated: 2015-07-31
Posted: 2015-08-13
Terminated: 2016-02-05
Recalling firm: Boston Scientific Corporation
Product: AngioJet Spiroflex Thrombectomy Set: Peripheral - UPN 106553-004, Catalog No.106553, 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.
Product code: DXE Catheter, Embolectomy
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: total of 9 units
Distribution: Worldwide Distribution - US including AZ, MO, OH and Internationally to GERMANY and SPAIN.
Product codes and lots: 163580

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2377-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2377-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-19	2015-08-13
Z-2378-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-19	2015-08-13
Z-2379-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-19	2015-08-13
Z-2380-2015	Class II	Terminated	Voluntary: Firm initiated	2015-08-19	2015-08-13

Product code DXE

K072769Class IIAngiojet Ultra; Xmi (105041), Xvg (105042) and Spiroflex (106553) Thrombectomy SetsPossis Medical, Inc. / cleared 2007-11-14

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)