Hazard

Coating Delamination recalls

15 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 15
Critical: 4
Severe: 5
Most recent: 2025-11-05

Of the 15 coating delamination recalls we have scored against our rubric, 4 (27%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (33%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all coating delamination recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–15 of 15

CriticalFDA (Devices)·Z-0188-2026·2025-11-05
Distal access catheters recalled after coating material lifting inside the lumen
Balt USA is recalling 207 MEGA Ballast Distal Access Platform catheters over a manufacturing defect in which coating material lifts within the catheter's distal lumen. The FDA has classified it Class I.
Product
Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180, MEGABT09190, MEGABT091100, MEGABT091110 Software Version: N/A Product Description: The Mega Ballast 091 is designed with a semi-rigid proximal shaft and a highly flex
Category
Medical Device
Distribution
12 states
SevereFDA (Devices)·Z-1760-2025·2025-05-28
Centerline Biomedical IOPS Guidewire 2 Coating Delamination Risk
Centerline Biomedical is recalling the IOPS Guidewire 2 (Lot 2404-2005) because the coating may delaminate during use, potentially compromising the guidewire's function during catheter placement procedures.
Product
Centerline Biomedical IOPS Guidewire 2, REF ATW-2; Sensorized wire used to navigate through vasculature to facilitate placement of a catheter
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-3103-2017·2017-09-13
MicroVention Traxcess 7 Mini Guidewire Recalled for Coating Delamination
MicroVention is recalling 34 units of Traxcess 7 Mini Guidewires because the hydrophilic coating may delaminate from the device.
Product
MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating, Ref GW0721006M, 1 guidewire per package, sterile, RX.
Category
Medical Device
Distribution
12 states
CriticalFDA (Devices)·Z-0307-2017·2016-11-16
FDA Recalls Pipeline Embolization Devices Due to Coating Delamination
Micro Therapeutics Inc is recalling Pipeline Embolization Devices because PTFE coating may delaminate and enter the bloodstream.
Product
Pipeline Embolization Device (Pipeline Classic) The device is indicated for the endovascular treatment of adults (22 year of age or older) with large or giant widenecked intracranial aneurysms (lAs) in the internal carotid artery from the petrous to the superior hypophyseal sege
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0310-2017·2016-11-16
Ev3 Neurovascular Recalls X-Celerator Hydrophilic Exchange Guidewires
Micro Therapeutics Inc is recalling X-Celerator Hydrophilic Exchange Guidewires because PTFE coating delamination may release material into the bloodstream.
Product
X-Celerator Hydrophilic Exchange Guidewire Catalog No. 103-0601-300 103-0601-350V10 103-0602-350V06 103-0601-300V01 103-0602-300 103-0602-350V09 103-0601-300V02 103-0602-300V01 103-0602-350V10 103-0601-300V03 103-0602-300V02 103-0601-300V06 103-0602-300v06 103-06
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1454-2014·2014-04-23
FDA Recalls Alligator Retrieval Devices Due to Coating Delamination Risk
Micro Therapeutics Inc is recalling Alligator Retrieval Devices because the PTFE coating may delaminate and detach from the delivery wire.
Product
Alligator Retrieval Device (ARD). Used in the peripheral and neurovasculature for foreign body removal.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1453-2014·2014-04-23
Ev3 Neurovascular Recalls Pipeline Embolization Devices Due to Coating Defect
Ev3 Neurovascular is recalling 32 Pipeline Embolization Devices because the PTFE coating may delaminate and detach from the delivery wire.
Product
Pipeline Embolization Device (PED). Used endovascular treatment of adults with intracranial aneurysms in the internal carotid artery.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0558-2014·2014-01-01
Abbott Recalls HT Connect Peripheral Guide Wires Due to Coating Delamination
Abbott Vascular is recalling HT Connect Peripheral Guide Wires because a small number of devices show partial delamination of the PTFE coating.
Product
HT Connect Peripheral Guide Wire Part Number Description 1012587 018 HT CONNECT 145 CM 1012588 018 HT CONNECT 195 CM 1012589 018 HT CONNECT 300 CM 1012590 018 HT CONNECT FLEX 145 CM 1012591 018 HT CONNECT FLEX 195 CM 1012592
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-0261-2014·2013-11-27
Medtronic Cougar Nitinol Guidewires Recalled for Coating Delamination Risk
Medtronic Vascular is recalling specific Cougar Nitinol Workhorse Guidewires because the PTFE coating may delaminate and detach from the device.
Product
Cougar¿ Nitinol Workhorse Guidewire: Models: CGRLS190HJ, CGRLS190HS, CGRLS190S, CGRLS300HS, CGRLS300S. CGRXT190HJ, CGRXT190HS, CGRXT190J, CGRXT190S, CGRXT300HJ, CGRXT300HS, CGRXT300J, CGRXT300S Medtronic guide wires are steerable guide wires that are used for the introduction
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0268-2014·2013-11-27
Medtronic Zinger Steerable Guidewires Recalled for Coating Delamination Risk
Medtronic Vascular is recalling Zinger Steerable Guidewires because the PTFE coating may delaminate and detach from the device.
Product
ZINGER¿ Steerable Guidewire; Models: LVZRLS180J, LVZRLS180S, LVZRMS180J, LVZRMS180S, LVZRXT180J, LVZRXT180S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0264-2014·2013-11-27
Medtronic ProVia Crossing Guidewire Recalled for Coating Delamination Risk
Medtronic Vascular is recalling ProVia Crossing Guidewires because the PTFE coating may delaminate and detach from the device.
Product
ProVia¿ CROSSING GUIDEWIRE; Models: 15PROV300HS, 3PROV180HS, 3PROV180SS, 3PROV300HS, 3PROV300SS, 9PROV180HS, 9PROV180SS Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary an
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0266-2014·2013-11-27
Medtronic Cougar Steerable Guidewires Recalled for Coating Delamination Risk
Medtronic Vascular is recalling 20 units of Cougar Steerable Guidewires because the PTFE coating may delaminate and detach.
Product
COUGAR¿ Steerable Guidewire; Models: LVCLS190J, LVCLS190S, LVCXT190J, LVCXT190S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0262-2014·2013-11-27
Medtronic Zinger Guidewires Recalled for Coating Delamination Risk
Medtronic Vascular is recalling Zinger Stainless Steel Workhorse Guidewires because the PTFE coating may delaminate and detach.
Product
Zinger¿ Stainless Steel Workhorse Guidewire; Models: ZNGRLS180HJ, ZNGRLS180HS, ZNGRMS180HJ, ZNGRMS180HS, ZNGRMS180S, ZNGRS180HJ, ZNGRS180HS, ZNGRS180S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or intervent
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0267-2014·2013-11-27
Medtronic Thunder Steerable Guidewire Recalled for Coating Delamination Risk
Medtronic Vascular is recalling 1,205 Thunder Steerable Guidewires because the PTFE coating may delaminate and detach from the device.
Product
THUNDER¿ Steerable Guidewire; Model: LVTNDR190S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may be used to reach and cross a target le
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0263-2014·2013-11-27
Medtronic Thunder Extra Support Guidewire Recalled for Coating Delamination Risk
Medtronic Vascular is recalling 58 Thunder Extra Support Guidewires because the PTFE coating may delaminate and detach from the device.
Product
THUNDER¿ Extra Support Guidewire; Models: THNDR190J, THNDR190S, THNDR300J, THNDR300S Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or interventional devices in the coronary and peripheral vasculature, and may b
Category
Medical Device
Distribution
Distributed nationwide