CLASS II Device recall · Reported 19 Aug 2015 · FDA Enforcement Report

AngioJet Spiroflex Thrombectomy Set: Peripheral - UPN recalled

Boston Scientific is recalling AngioJet Spiroflex Thrombectomy Set: Peripheral - UPN 106553-004, distributed in Arizona, Missouri, Ohio. The recall was initiated on 31 Jul 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes163580

Quantity recalledtotal of 9 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2377-2015
FDA event ID: 71849
Recalling firm: Boston Scientific, Maple Grove, MN
Classification: Class II
Status: Terminated
Recall initiated: 31 Jul 2015
FDA classified: 13 Aug 2015
Reported: 19 Aug 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Heart & Vascular Devices

Timeline

31 Jul 2015	Recall initiated by company
13 Aug 2015	Classified by FDA	+13 days
19 Aug 2015	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

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

Arizona Missouri Ohio

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

163580

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 71849

This product is part of a recall event; the main page for the event is AngioJet Solent Dista Thrombectomy Set: UPN recalled.

Reported	Class	Recall	Company	Reason	Where
19 Aug 2015	CLASS II	AngioJet Solent Dista Thrombectomy Set: UPN recalled	Boston Scientific	Device Malfunction	AZ, MO, OH
19 Aug 2015	CLASS II	AngioJet Solent Omni Thrombectomy Set: UPN 109681-004 recalled	Boston Scientific	Device Malfunction	AZ, MO, OH
19 Aug 2015	CLASS II	AngioJet AVX Thrombectomy Set: UPN recalled by Boston Scientific	Boston Scientific	Device Malfunction	AZ, MO, OH

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