CLASS II Device recall · Reported 7 Dec 2016 · FDA Enforcement Report

ELCA Coronary Atherectomy Catheter recalled by Spectranetics

Spectranetics is recalling ELCA Coronary Atherectomy Catheter, distributed nationwide in the US. The recall was initiated on 31 Oct 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesFDD16D20A; FDD16E02A; FBM16D15B; FBM16F17A; FHH16D05B; FHH16G13A FHH16D12A; FHH16G22A; FHH16D19A; FHH16H05A; FHH16D26A; FHH16H08C FHH16D27A; FHH16H12A; FHH16E03A; FHH16H15A; FHH16E13A; FHH16H17A FHH16E16A; FHH16H24A; FHH16F03A; FHH16H29A; FHH16F07A; FHH16J19A FHH16F22A ; FHH16J29A; FHH16F28A; FTT16D07A; FTT16F24A; FTT16E23A; FTT16H04A; FTT16F01A; FTT16J09A; FUU16E18A; FUU16F30A; FUU16F08A; FBB16D18A; FBB16H03A; FBB16F01A; FBB16H03B; FBB16G11A; FBB16H26A FBB16G20A; FLL16G21A; FHH16G28A; FHH16J09B

Quantity recalled3,141 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-0662-2017
FDA event ID: 75617
Recalling firm: Spectranetics, Colorado Springs, CO
Classification: Class II
Status: Terminated
Recall initiated: 31 Oct 2016
FDA classified: 1 Dec 2016
Reported: 7 Dec 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Heart & Vascular Devices

Timeline

31 Oct 2016	Recall initiated by company
1 Dec 2016	Classified by FDA	+31 days
7 Dec 2016	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

Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon due to potentially compromised integrity of the outer sterile packaging.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

ELCA Coronary Atherectomy Catheter. Models: 110-001, 110-002, 110-004, 114-009, 117-016, 117-205, 120-009 The Laser Catheters are used in conjunction with the Spectranetics CVX-300¿ Excimer Laser System and are intended for use in patients with single or multivessel coronary artery disease, either as a stand-alone modality or in conjunction with Percutaneous Transluminal Coronary Balloon Angioplasty (PTCA), and who are acceptable candidates for coronary artery bypass graft (CABG) surgery.

Where it was distributed

Worldwide Distribution - US (nationwide and PR) Internationally to Austria, Belgium, Cyprus, Denmark, France, Germany, Hungary, Italy, Netherlands, Norway, Poland, Spain, Sweden, Switzerland, United Kingdom, Australia, Bahrain, Brazil, Canada, Chile, Colombia, Dominican Republic, Israel, Japan, Kuwait, Taiwan, Thailand.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Which lots are affected?

FDD16D20A; FDD16E02A; FBM16D15B; FBM16F17A; FHH16D05B; FHH16G13A FHH16D12A; FHH16G22A; FHH16D19A; FHH16H05A; FHH16D26A; FHH16H08C FHH16D27A; FHH16H12A; FHH16E03A; FHH16H15A; FHH16E13A; FHH16H17A FHH16E16A; FHH16H24A; FHH16F03A; FHH16H29A; FHH16F07A; FHH16J19A FHH16F22A ; FHH16J29A; FHH16F28A; FTT16D07A; FTT16F24A; FTT16E23A; FTT16H04A; FTT16F01A; FTT16J09A; FUU16E18A; FUU16F30A; FUU16F08A; FBB16D18A; FBB16H03A; FBB16F01A; FBB16H03B; FBB16G11A; FBB16H26A FBB16G20A; FLL16G21A; FHH16G28A; FHH16J09B

Where was it sold?

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

2 other products · FDA event 75617

This product is part of a recall event; the main page for the event is Bridge Occlusion Balloon recalled by Spectranetics.

Reported	Class	Recall	Company	Reason	Where
7 Dec 2016	CLASS II	Bridge Occlusion Balloon recalled by Spectranetics	Spectranetics	Sterility	Nationwide
7 Dec 2016	CLASS II	Turbo Elite Atherectomy Catheter recalled by Spectranetics	Spectranetics	Sterility	Nationwide

More recalls from Spectranetics

All 12

Reported	Class	Recall	Company	Reason	Where
26 Feb 2025Device	CLASS I	Intact Vascular Tack Endovascular System recalled by Spectranetics	Spectranetics	Potency & Assay	Nationwide
20 Dec 2023Device	CLASS II	Turbo-Elite Laser Atherectomy Catheter 2.0 RX recalled by Spectranetics	Spectranetics	Packaging Defects	Nationwide
23 Nov 2022Device	CLASS II	Philips Laser System recalled by Spectranetics	Spectranetics	Device Malfunction	30 states
20 Jul 2022Device	CLASS II	Philips Laser System recalled by Spectranetics	Spectranetics	Other	23 states
3 Jun 2020Device	CLASS II	Bridge Occlusion Balloon recalled by Spectranetics	Spectranetics	Device Malfunction	Nationwide

Other Heart & Vascular Devices recalls

All 6,220

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14 Oct 2026Device	CLASS II	TufTex¿ Over-the-Wire Embolectomy Catheter recalled	LeMaitre Vascular	Other	Nationwide
14 Oct 2026Device	CLASS II	Endovascular Pack kits recalled by Avid Medical	Avid Medical	Other	Nationwide
14 Oct 2026Device	CLASS II	Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled	Stryker Sustainability Solutions	Particulate Matter	Nationwide
7 Oct 2026Device	CLASS II	Medical convenience kits containing BD CliniClean Pericare recalled	American Contract Systems	Device Malfunction	Nationwide
7 Oct 2026Device	CLASS II	Medical convenience kits containing BD CliniClean Pericare recalled	American Contract Systems	Device Malfunction	Nationwide