CLASS I Device recall · Reported 13 May 2020 · FDA Enforcement Report
0.035"(.89mm)x150 cm guidewire. Model 114135150. Soft Tip 3.5cm. recalled
Argon Medical Devices is recalling 0.035"(.89mm)x150 cm guidewire. Model 114135150. Soft Tip 3.5cm.. The recall was initiated on 4 Dec 2019 and the FDA has classified it as Class I.
Check your package
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-1792-2020
- FDA event ID
- 85398
- Recalling firm
- Argon Medical Devices, Athens, TX
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 4 Dec 2019
- FDA classified
- 7 May 2020
- Reported
- 13 May 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 4 Dec 2019 | Recall initiated by company | |
| 7 May 2020 | Classified by FDA | +155 days |
| 13 May 2020 | 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
The stiffness of the soft end of the guidewire caused tissue perforation.
Product as listed by the FDA
0.035"(.89mm)x150 cm guidewire. Model 114135150. Soft Tip 3.5cm. REF/UDI: 114135150/(01)20886333008074. RxOnly.STERILE EO
Where it was distributed
No US consignees. OUS - Sweden, Norway, Denmark, Greece, Slovenia, Turkey, Hong Kong, England
Questions about this recall
Why was it recalled?
The stiffness of the soft end of the guidewire caused tissue perforation.
Which lots are affected?
Guidewire Model 114135150; LOT numbers: 11248718, 11251204, 11260495. 11268741, 11242667, 11241250 and 11239540
Where was it sold?
No US consignees. OUS - Sweden, Norway, Denmark, Greece, Slovenia, Turkey, Hong Kong, England
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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
1 other product · FDA event 85398| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | 0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. recalled | Argon Medical Devices | Other | TX |
More recalls from Argon Medical Devices
All 50| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | L-Cath PICC S/L Peripherally Inserted Central Catheter: (1.9F) recalled | Argon Medical Devices | Labeling Errors | 28 states |
| Device | CLASS II | L-Cath Midline S/L Catheter (3F) recalled by Argon Medical Devices | Argon Medical Devices | Labeling Errors | 28 states |
| Device | CLASS I | Bone Marrow Tray recalled by Argon Medical Devices | Argon Medical Devices | Sterility | Nationwide |
| Device | CLASS I | T-Lok Bone Marrow Tray recalled by Argon Medical Devices | Argon Medical Devices | Sterility | Nationwide |
| Device | CLASS I | One-Piece Introducer Tray recalled by Argon Medical Devices | Argon Medical Devices | Sterility | Nationwide |
Other Heart & Vascular Devices recalls
All 6,220| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | TufTex¿ Over-the-Wire Embolectomy Catheter recalled | LeMaitre Vascular | Other | Nationwide |
| Device | CLASS II | Endovascular Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled | Stryker Sustainability Solutions | Particulate Matter | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |