Food, drugs, devices › Boston Scientific Corporation

Device recall: AngioJet Spiroflex Thrombectomy Set: Peripheral - UPN 106553-004, Catalog No.106553, Sterilized Using Ethylene Oxide. Fo

FDA enforcement event 71849 · Class II · initiated 31 Jul 2015 · status Terminated · terminated 5 Feb 2016

DeviceVoluntary: Firm initiated4 product recordsMaple Grove, MN

Boston Scientific Corporation (Maple Grove, MN) initiated this device recall on 31 Jul 2015; FDA lists 4 product records under event 71849, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.

Status: Terminated, terminated 5 Feb 2016. Initiation: voluntary: firm initiated. Boston Scientific Corporation has 162 enforcement events on this register, with a median of 2 product records per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Boston Scientific Corporation, Maple Grove, MN.

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."

Distribution

"Worldwide Distribution - US including AZ, MO, OH and Internationally to GERMANY and SPAIN."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-2377-2015	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.	total of 9 units	Class II	Terminated	19 Aug 2015
Z-2378-2015	AngioJet SOLENT Omni Thrombectomy Set: UPN 109681-004 & 109681-001, Catalog No 109681, Sterilized. 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.	total of 9 units	Class II	Terminated	19 Aug 2015
Z-2379-2015	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.	total of 9 units	Class II	Terminated	19 Aug 2015
Z-2380-2015	AngioJet AVX Thrombectomy Set: UPN 105039-001, Catalog No.105039, 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.	total of 9 units	Class II	Terminated	19 Aug 2015

Context

91%of 2015 device events are Class II1,153 events that year

4product records in this eventfirm median: 2

162events on this register for the firm

Other enforcement events for Boston Scientific Corporation

Initiated	Product (first record)	Type	Class	Records
6 Aug 2026	LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US, Model Number 7260, All Ver	Device	Class II	3
22 Jul 2026	Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord, (1) Power Adaptor, (1)DVI Cable, (1)	Device	Class II	1
14 Jul 2026	OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.	Device	Class II	2
9 Jul 2026	Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous catheter	Device	Class I	2
30 Jun 2026	Rapid Refill Continuous Injection System, UPN M00566001	Device	Class II	1
30 Jun 2026	Radial Jaw 4 Standard Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 SC 240cm Box 20;	Device	Class II	3
19 Jun 2026	Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M00139509001; Radiological Image Processing Sys	Device	Class II	1
11 Jun 2026	FARADRIVE Steerable Sheath Clear IDE, used to facilitate access to the vasculature and into the chambers of the heart, M	Device	Class II	4
11 Jun 2026	FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Cathet	Device	Class II	3
11 Jun 2026	FARASTAR Ablation Generator EU, Pulsed Field Ablation Generator, Product ID 61M401; Percutaneous Cardiac Ablation Cathet	Device	Class II	1

All 162 events for Boston Scientific Corporation

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall 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."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "Worldwide Distribution - US including AZ, MO, OH and Internationally to GERMANY and SPAIN."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 5 Feb 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.